Notes:

1. For purposes of this entire policy, Aetna covers diagnostic infertility services to determine the cause of infertility and treatment only when specific coverage is provided under the terms of a member’s benefits plan. All coverage is subject to the terms and conditions of the plan. The following discussion is applicable only to members whose plans cover infertility services.

2. For purposes of this policy, a member is considered infertile if he or she is unable to conceive or produce conception after one year of frequent, unprotected heterosexual sexual intercourse, or six months of frequent, unprotected heterosexual sexual intercourse if the female partner is over age 35 years. Alternately, a woman without a male partner may be considered infertile if she is unable to conceive or produce conception after at least twelve (12) cycles of donor insemination (six cycles for women age 35 or older). However, this definition of infertility may vary due to state mandates and plan customization; please check plan documents.

3. Infertility services are considered not medically necessary once pregnancy is established and a fetal heartbeat is detected. Infertility services beyond eight weeks of pregnancy are not considered medically necessary.

1. Females: Basic Infertility Services

   The following services are considered medically necessary for diagnosis and/or treatment of infertility.

   1. History and physical examination

   2. Laboratory studies:

      1. Anti-sperm antibodies (e.g., immunobead or mixed antiglobulin method)
      2. Chlamydia trachomatis screening (See CPB 433 - Chlamydia trachomatis - Screening and Diagnosis.)
      3. Post-coital testing (PCT) (Simms-Huhner test) of cervical mucus
      4. Fasting and 2 hours post 75 gram glucose challenge levels
      5. Lipid panel (total cholesterol, HDL cholesterol, triglycerides)
      6. Rubella serology

      7. Serum hormone levels

         1. Androgens (testosterone, androstenedione, dehydroepiandrosterone sulfate (DHEA-S) if there is evidence of hyperandrogenism (e.g., hirsuitism, acne, signs of virilization) or ovulatory dysfunction

         2. Gonadotropins (serum FSH, LH) for women with irregular menstrual cycles (see Appendix for medical necessity limitations) or age-related ovulatory dysfunction. Note: Aetna considers urinary FSH testing to be experimental and investigational. Serum, not urinary, FSH is the standard of care for determination of menopausal status (AACE, 1999; NAMS, 2000; SOGC, 2002)

            Note: Some plans exclude coverage of infertility services for women with ovarian failure, defined as an FSH level greater than 19 mIU/ml on day 3 of any menstrual cycle. Please check benefit plan descriptions.

         3. Human chorionic gonadotrophin (hCG) (see Appendix for medical necessity limitations)
         4. Prolactin for women with an ovulatory disorder, galactorrhea, or a pituitary tumor
         5. Progestins (progesterone, 17-hydroxyprogesterone) (see Appendix for medical necessity limitations)
         6. Estrogens (estradiol) (see Appendix for medical necessity limitations)
         7. Thyroid stimulating hormone (TSH)
         8. Adrenocortitrophic hormone (ACTH) for ruling out Cushing's syndrome or Addison's disease in women who are amenorrheic

         9. Clomiphene citrate challenge test

      8. Karyotype testing for couples with recurrent pregnancy loss (two or more consecutive spontaneous abortions) (See CPB 348 - Recurrent Pregnancy Loss.)

      9. The following laboratory studies are considered experimental and investigational:

         1. Serum inhibin B measurement (value in assessing ovarian reserve is uncertain)
         2. Antiprothrombin antibodies (See CPB 662 - Antiprothrombin Antibody Testing.)
         3. Embryotoxicity assay (See CPB 348 - Recurrent Pregnancy Loss.)
         4. Endometrial function test (EFT) (cyclin E and p27).

            Note: Many plans exclude coverage of home pregnancy tests and home ovulation test kits. Please check benefit plan descriptions.

   3. Diagnostic procedures:

      The following diagnostic procedures are considered medically necessary:

      1. Endometrial biopsy
      2. Hysterosalpingography (hysterosalpingogram (HSG)) or hysterosalpingo-contrast-ultrasonography to screen for tubal occlusion
      3. Laparoscopy and contrast dye to assess tubal and other pelvic pathology, and to follow up on hysterosalpingography abnormalities.
      4. Hysteroscopy, salpingoscopy (falloscopy), hydrotubation where clinically indicated.
      5. Ultrasound (e.g., ovarian, transvaginal, pelvic) (see Appendix for medical necessity limitations)
      6. Sonohysterography
      7. CT or MR imaging of sella turcica is considered medically necessary if prolactin is elevated

      8. Monitoring of ovarian response to ovulatory stimulants:

         1. Serial ovarian ultrasounds are considered medically necessary for cycle monitoring (see Appendix for medical necessity limitations)
         2. Estradiol (see Appendix for medical necessity limitations)
         3. FSH (see Appendix for medical necessity limitations)
         4. hCG quantitative (see Appendix for medical necessity limitations)
         5. LH assay (see Appendix for medical necessity limitations)

         6. Progesterone (see Appendix for medical necessity limitations).

   4. Nonsurgical treatments:
      
      The following nonsurgical treatments are considered medically necessary:

      1. Estrogens (e.g., estrone and conjugated estrogens (Premarin))
      2. Corticosteroids (e.g., dexamethasone, prednisone)
      3. Progestins (oral or intramuscular progestins and progesterone vaginal suppositories, see CPB 510 - Progestins )
      4. Metformin (Glucophage) combined with clomiphene citrate for anovulatory women with polycystic ovary syndrome who have not responded to clomiphene citrate
      5. Prolactin inhibitors (bromocriptine (Parlodel), cabergoline (Dostinex), peroglide (Permax)) for women with ovulatory disorders due to hyperprolactinemia

      6. Ovulation induction:

         Ovulation induction with oral clomiphene citrate (Clomid, Serophene) or tamoxifen (Novaldex).

      Note: The medications listed above may not be covered for members without pharmacy benefit plans; in addition, some pharmacy benefit plans may exclude or limit coverage of some or all of these medications. Please check benefit plan descriptions for details.

      The following non-surgical treatments are considered experimental and investigational:
      
      Leukocyte immunization (immunizing the female partner with the male partner's leukocytes) (See CPB 348 - Recurrent Pregnancy Loss.); and 

      FSH manipulation of women with elevated FSH levels. (An elevated FSH level is a marker of reduced ovarian reserve, as occurs with advancing age. Elevated FSH-related (i.e., age-related) infertility has not been proven to be affected by interventions to reduce FSH levels.)

   5. Infertility surgery:

      1. Laparoscopy for treatment of pelvic pathology
      2. Ovarian wedge resection or ovarian drilling for women with polycystic ovarian syndrome who have not responded to clomiphene citrate
      3. Removal of myomas, uterine septa, cysts, ovarian tumors, and polyps
      4. Open or laparoscopic resection, vaporization, or fulguration of endometriosis implants plus adhesiolysis in women with endometriosis
      5. Laparoscopic cystectomy for women with ovarian endometriomas
      6. Hysteroscopic adhesiolysis for women with amenorrhea who are found to have intra-uterine adhesions
      7. Tubal ligation (salpingectomy) for women with hydrosalpinges who are contemplating in vitro fertilization, as this has been demonstrated to improve the chance of a live birth before in vitro fertilization treatment
      8. Hysteroscopic or fluoroscopic tubal cannulation (salpingostomy, fimbrioplasty), selective salpingography plus tubal catheterization, or transcervical balloon tuboplasty for women with proximal tubal obstruction (See CPB 347 - Transcervical Balloon Tuboplasty.)

      9. Surgical tubal reconstruction (unilateral or bilateral tuboplasty) and tubal anastomosis) for women with mid or distal tubal occlusion and for women with proximal tubal disease where tubal cannulation has failed or where severe proximal tubal disease precludes the likelihood of successful cannulation.

      Note: Most plans exclude coverage for reversal of sterilization surgery (including sterilization by tubal ligation or vasectomy) and exclude infertility services for couples in which either of the partners has had a previous sterilization procedure, with or without surgical reversal, and for females who have undergone a hysterectomy. Please check benefit plan descriptions for details.

2. Females: Additional Infertility Services

   The following additional services (referred to in some plans as "Comprehensive Infertility Services") may be considered medically necessary if the member is unable to conceive after treatment with Basic Infertility Services, or if the member's diagnosis suggests that there is no reasonable chance of pregnancy as a result of Basic Infertility Services.

   1. Injectable medications (See CPB 020 - Injectable Medications.)

      1. Gonadotropin releasing hormone (GnRH) (luteinizing hormone releasing hormone (LHR-H)) by intermittent subcutaneous injections or by GnRH infusion pump (See CPB 501 - Gonadotropin-Releasing Hormone Analogs and Antagonists for additional information and limitations.)

         1. Gonadorelin (Synarel, Factrel)
         2. Goserelin (Zoladex)

         3. Leuprolide (Lupron)

         Considered medically necessary for the following indications:

         1. For use, in addition to gonadotropin stimulation, in pituitary down-regulation as part of in vitro fertilization treatment (Note: coverage of GnRH for this indication is limited to plans that cover advanced reproductive technologies. Please check benefit plan descriptions for details.)

         2. Pulsatile administration of gonadotropin-releasing hormone is considered medically necessary in women with WHO Group I ovulation disorders (hypothalamic pituitary failure, characterized by hypothalamic amenorrhea or hypogonadotropic hypogonadism) (see appendix for WHO classification of ovulation disorders).

      2. Gonadotropins

         1. Human chorionic gonadotropin (hCG) (A.P.L., Novarel, Pregnyl, Profasi HP, Ovidrel, Chorex, Choron)
         2. Human menopausal gonadotropin (hMG) (menotropins) (LH and FSH) (Menopur, Repronex)
         3. Recombinant follitropin products (recombinant FSH) (Follitropin alfa (Gonal-F); Follitropin beta (Follistim))

         4. Urofollitropin (human FSH) (Fertinex, Bravelle).

         Gonadotropins are considered medically necessary for the following indications:

         1. Women with WHO Group II ovulation disorders such as polycystic ovary syndrome who do not ovulate with clomiphene citrate or tamoxifen. (See appendix for WHO classification of ovulation disorders.)
         2. For use in pituitary down-regulation as part of in vitro fertilization treatment (Note: coverage of gonadotropins for this indication is limited to plans that cover advanced reproductive technologies. Please check benefit plan descriptions for details.)
         3. Pulsatile administration of gonadotropins are considered medically necessary for women with WHO Group I ovulation disorders (hypothalamic pituitary failure, characterized by hypothalamic amenorrhea or hypogonadotropic hypogonadism).

         4. Clomiphene plus gonadotropins may be considered medically necessary in women who do not ovulate using clomiphene alone.

      3. Gonadotropin releasing hormone (GnRH) antagonists

         GnRH antagonists (ganirelix acetate, Cetrotide) are considered medically necessary for women undergoing assisted reproduction techniques (ART) to prevent premature LH surge in women undergoing controlled ovarian stimulation, allowing the follicles to mature for planned oocyte collection. (Note: coverage of GnRH antagonists for this indication is limited to plans that cover advanced reproductive technologies.  Please check benefit plan descriptions for details.)

      4. Growth hormone for infertility treatment is considered experimental and investigational. There is inadequate evidence that the use of adjuvant growth hormone treatment during ovulation induction improves pregnancy rates. See CPB 170 - Growth Hormone (GH), Growth Hormone Releasing Hormone (GHRH), and Growth Hormone Antagonists.

      5. Intravenous immunoglobulins are considered experimental and investigational for treatment of infertility. See CPB 348 - Recurrent Pregnancy Loss; and CPB 206 - Intravenous Immunoglobulins (IVIG).

      Note: Many plans exclude coverage for infertility injectable medications; other plans may limit coverage of ovulation induction cycles with menotropins to six (6) per lifetime. Please check plan documents for details.

   2. Artificial insemination: See section  IV below.

3. Males: Infertility Services

   The following services are considered medically necessary for diagnosis and/or treatment of infertility in men:

   1. History and physical examination

   2. Laboratory studies:

      1. Anti-sperm antibodies (e.g., immunobead or mixed antiglobulin method)

      2. Cultures

         1. Urine
         2. Semen

         3. Prostatic secretion

      3. Serum hormone levels

         1. Thyroid stimulating hormone (TSH) for men with symptoms of thyroid disease
         2. Gonadotropins (FSH, LH)
         3. Prolactin for men with reduced sperm counts, galactorrhea, or pituitary tumors
         4. Androgens (testosterone, free testosterone)
         5. Estrogens (e.g., estradiol, estrone)
         6. Adrenal cortical stimulating hormone (ACTH)
         7. Growth hormone (GH)
         8. 17-hydroxyprogesterone

         9. Sex hormone binding globulin (SHGB) for men with signs and symptoms of hypogonadism and low normal testosterone levels.  (SHGB is not indicated in the routine evaluation of male infertility).

      4. Semen analysis (volume, pH, liquefaction time, sperm concentration, total sperm number, motility (forward progression), motile sperm per ejaculate, vitality, round cell differentiation (white cells versus germinal), morphology, viscosity, agglutination) is considered medically necessary for the evaluation of infertility in men.

         1. If the result of the first semen analysis is abnormal and the man has not been exposed to gonadotoxins, up to two repeat confirmatory tests may be considered medically necessary.
         2. For men with abnormal semen analysis exposed to gonadotoxins, up to four semen analyses are considered medically necessary.

         3. For men with a normal initial semen analysis, a repeat semen analysis is considered medically necessary if there is no pregnancy four months after the initial normal semen analysis.

      5. Vasography
      6. Semen leukocyte analysis (e.g., Endtz test, immunohistochemical staining)

      7. Seminal fructose

         Note: Seminal alpha-glucosidase, zinc, citric acid, and acid phosphatase are considered experimental and investigational.

      8. Blood test for cytogenetic analysis (karyotype and FISH) in men with severe deficits of semen quality or azoospermia (for consideration of ICSI)
      9. Cystic fibrosis mutation testing in men with congenital absence of vas deferens
      10. Y chromosome microdeletion analysis in men with severe deficits of semen quality or azoospermia (for consideration of ICSI). Note: Y chromosome microdeletion analysis is not routinely indicated before ICSI, and is subject to medical necessity review
      11. Post-coital test (PCT) (Simms-Huhner test) of cervical mucus

      12. Sperm function tests:

          1. Sperm penetration assay (zona-free hamster egg penetration test)

          Note: The following sperm function tests are considered experimental and investigational:

          2. Sperm chromatin assay
          3. Sperm DNA fragmentation assay
          4. Hemizona assay
          5. In vitro testing of sperm penetration
          6. Hypoosmotic swelling test
          7. Sperm nucleus maturation

          8. Hyaluronan binding assay.

      13. Karyotyping of couples with recurrent pregnancy loss (defined as two or more consecutive spontaneous abortions) (See CPB 348 - Recurrent Pregnancy Loss.)

   3. Diagnostic procedures:

      1. Scrotal exploration
      2. Testicular biopsy
      3. Scrotal (testicular) ultrasound (See CPB 532 - Scrotal Ultrasonography.)
      4. Venography
      5. Vasography
      6. Transrectal ultrasound (See CPB 001 - Transrectal Ultrasound.)

      7. CT or MR imaging of sella turcica if prolactin is elevated.

      Note: Fine needle aspiration (“mapping”) of testes is considered experimental and investigational.

   4. Treatments:

      1. Endocrine management

         1. Clomiphene (Clomid, Serophene)
         2. Corticosteroids (e.g., dexamethasone, prednisone)
         3. Antiestrogens (tamoxifen (Nolvadex)) for men with elevated estrogen levels.
         4. Prolactin inhibitors (bromocriptine (Parlodel), cabergoline (Dostinex)) for persons with hyperprolactinemia
         5. Thyroid hormone replacement for men with thyroid deficiency
         6. Androgens (testosterone) for persons with documented androgen deficiency

         7. Aromatase inhibitors (testolactone).

      2. Gonadotropins and gonadotropin releasing hormone for men with hypogonadotropic hypogonadism, a rare cause of male infertility (see CPB 501 - Gonadotropin-Releasing Hormone Analogs and Antagonists for additional information and limitations):

         1. Human chorionic gonadotropins (hCG) (A.P.L., Novarel, Pregnyl, Profasi HP, Ovidrel, Chorex, Choron)
         2. Choriogonadotropin alpha
         3. Human menopausal gonadotropins (hMG) (menotropins) (Menopur, Repronex)

         4. Gonadotropin releasing hormone (GnRH) (luteinizing hormone releasing hormone (LHRH)), by intermittent subcutaneous injections or by GnRH infusion pump

            1. Gonadorelin (Synarel, Factrel)
            2. Goserelin (Zoladex)

            3. Leuprolide (Lupron).

         5. Recombinant follitropin products (recombinant FSH) (Follitropin alfa (Gonal-F); Follitropin beta (Follistim)

         6. Urofollitropins (human FSH) (Fertinex, Bravelle).

         The above medications are considered experimental and investigational for idiopathic male infertility (i.e., for men without documented hypogonadotropic hypogonadism) because they have not been found to be effective for this indication.

         Note: Many plans that otherwise cover infertility treatments exclude coverage for infertility injectable medications. Please check benefit plan descriptions.

      3. Antibiotics for men with an identified infection.
      4. Varicocelectomy (spermatic vein ligation) (See CPB 413 - Percutaneous Embolization of Varicocele.)
      5. Spermatocelectomy and hydrocelectomy

      6. Surgical repair of vas deferens: vasovasostomy

         Note: Most plans exclude coverage for reversal of sterilization procedures. This would include vasectomy. Please check benefit plan descriptions for details.

      7. Surgical correction of epididymal blockage for men with obstructive azoospermia.

         1. Epididymectomy
         2. Epididymovasostomy
         3. Excision of epididymal tumors and cysts

         4. Epididymostomy.

      8. Transurethral resection of ejaculatory ducts (TURED) for obstruction of ejaculatory ducts
      9. Orchiopexy

      10. Alpha sympathomimetic agents (for retrograde ejaculation) (e.g., phenylephrine, imipramine).

      Note: Under most Aetna benefit plans, self-administered prescription medications are covered under the pharmacy benefit. Please check benefit plan descriptions.

4. Artificial Insemination

   1. Aetna considers artificial insemination (intracervical or intrauterine (IUI)) medically necessary for infertile couples with mild male-factor fertility problems, unexplained infertility problems, minimal to mild endometriosis, or couples undergoing menotropin ovarian stimulation.
   2. Aetna considers clomiphene-citrate-stimulated artificial insemination (intracervical or intrauterine (IUI)) medically necessary for infertile women with WHO Group II ovulation disorders such as polycystic ovarian syndrome who ovulate with clomiphene citrate but have not become pregnant after ovulation induction with clomiphene.

   3. Electroejaculation is considered medically necessary DME to overcome total anejaculation secondary to neurologic impairment, which most commonly occurs among members with the following conditions:

      1. Spinal cord injury
      2. Prior retroperitoneal surgery (most commonly retroperitoneal lymphadenectomy as a treatment of testicular cancer)

      3. Diabetic neuropathy.

   4. Donor insemination is considered medically necessary for the following indications:

      1. Obstructive azoospermia
      2. Nonobstructive azoospermia
      3. Infectious disease in the male partner (such as HIV)*
      4. Severe rhesus isoimmunization
      5. Severe deficits in semen quality in couples who do not wish to undergo intracytoplasmic sperm injection.

      6. Where there is a high risk of transmitting a genetic disorder in the male partner to the offspring.*

   Notes:

   Many Aetna plans that otherwise cover infertility services exclude coverage of fees associated with donor insemination (including semen donor recruitment, selection and screening, and cryostorage of sperm). In addition, cryopreservation of semen is not considered treatment of disease. Please check benefit plan descriptions for details.

   * Some plans limit coverage of donor insemination to couples who are infertile. Under these plans, donor insemination would not be covered for these indications (infectious disease in male partner, high risk of transmitting a genetic disorder) as these do not meet the contractual definition of infertility. Please check benefit plan descriptions.

   Note: Some Aetna benefit plans may exclude coverage of artificial insemination (AI). For Aetna benefit plans that cover artificial insemination, coverage is typically limited to six (6) cycles per lifetime. Please check benefit plan descriptions.

5. Advanced Reproductive Technology

   The following Advanced Reproductive Technologies (ART) procedures are considered medically necessary for women with infertility who meet either of the following criteria:

   1. Women who have failed three or more cycles of intrauterine insemination with gonadotropin (FSH) or clomiphene citrate ovarian hyperstimulation.

      or

   2. Couples for whom natural or artificial insemination would not be expected to be effective, including:

      1. Men with azoospermia or severe deficits in semen quality or quantity (see appendix); or

      2. Women with tubal factor infertility:

         1. Bilateral tubal disease (e.g., tubal obstruction, absence, or hydrosalpinges).
         2. Endometriosis stage 3 or 4.

         3. Failure to conceive after pelvic surgery with restoration of normal pelvic anatomy (see section  I. E above for pelvic surgery procedures for infertility):

            1. After trying to conceive for 6 months if less than 40 years of age;

            2. After trying to conceive for 3 months if 40 years of age or older.

         4. Infertility resulting from ectopic pregnancy
         5. Ectopic pregnancy occurring during infertility treatment.

         6. Unilateral hydrosalpinx with failure to conceive:

            1. After trying to conceive for 12 months if less than 40 years of age;

            2. After trying to conceive for 6 months if 40 years of age or older.

      3. Inadvertent ovarian hyperstimulation (estradiol level was greater than 1000 pg/mL plus greater than 3 follicles > 16 mm or 4 to 8 follicles > 14 mm or a larger number of smaller follicles) during preparation for a planned stimulated IUI cycle in women less than 40 years of age with a diagnosis other than polycystic ovarian syndrome. In women 40 year of age or older, it is not generally medically necessary to convert an IUI cycle to IVF due to ovarian hyperstimulation.

   Note: Coverage is limited to plans with an ART benefit; please check benefit plan descriptions):

   1. In vitro fertilization (IVF) with embryo transfer:

      1. Oocyte (egg) retrieval via laparoscope or transvaginal needle aspiration of follicles
      2. Oocyte (egg) insemination in laboratory dish
      3. Embryo transfer (transcervical transfer back to the donor) (including cryopreserved embryo transfer)
      4. Sperm preparation and capacitation
      5. Intracytoplasmic sperm injection (ICSI) is medically necessary where there is azoospermia or oligospermia (obstructive or nonobstructive), severe deficits in semen quality or quantity (see appendix), or for couples where a previous in vitro fertilization treatment cycle has resulted in failed or poor (see appendix) fertilization. (For use of ICSI in preimplantation genetic diagnosis, see CPB 358 - Invasive Prenatal Diagnosis of Genetic Diseases.)

      6. Frozen embryo transfer (FET) (Note: It may be considered medically necessary to freeze embryos not transferred during a stimulated in vitro fertilization treatment cycle, and to transfer the embryos before the next stimulated treatment cycle because this will minimize ovulation induction and egg collection, both of which carry risks for the woman and use more resources.) Before proceeding to the next fresh ART cycle, FET using cryopreserved embryos must be used if 3 or more cryopreserved embryos of a similar developmental stage are available (4 for women 35 years of age or older).

         Note: Some Aetna plans have a specific contractual exclusion of coverage of any charges associated with embryo cryopreservation or storage of cryopreserved embryos. Please check benefit plan descriptions. In addition, cryopreservation of embryos (other than short-term cryopreservation of embryos for persons under active infertility treatment) is not considered treatment of disease.

      7. Assisted Hatching is considered medically necessary for any of the following indications:

         1. Multiple (2 or more) failed IVF attempts; or
         2. Age greater than 38 years; or

         3. Thickened zona pellucida.

   2. Gamete intrafallopian transfer (GIFT) is considered medically necessary as an alternative to in vitro fertilization for women with female factor infertility. GIFT includes:

      1. Oocyte (egg) retrieval via laparoscope

      2. Immediate loading of the eggs into a transfer catheter with sperm and insertion into the patient’s fallopian tube via the same laparoscope (the patient must have at least one patent fallopian tube for this method to be an effective treatment for infertility).

      GIFT is considered experimental and investigational for person with male factor infertility or unexplained infertility problems because there is insufficient evidence to recommend GIFT over in vitro fertilization for these indications.

   3. Zygote intrafallopian transfer (ZIFT), tubal embryo transfer (TET), pronuclear stage tubal embryo transfer (PROUST) is considered medically necessary as an alternative to in vitro fertilization for women with female factor infertility.

      ZIFT is considered experimental and investigational for persons with male factor infertility or unexplained infertility problems because there is insufficient evidence to recommend ZIFT over in vitro fertilization for these indications.

   4. Specialized sperm retrieval techniques (including vasal sperm aspiration, microsurgical epididymal sperm aspiration (MESA), percutaneous epididymal sperm aspiration (PESA), electroejaculation, testicular sperm aspiration (TESA), seminal vesicle sperm aspiration, and sperm recovery from bladder or urine for retrograde ejaculation) are considered medically necessary to overcome anejaculation.

   5. Oocyte donation is considered medically necessary for managing infertility problems associated with the following conditions, when the infertile member is the intended recipient of the resulting embryos:

      1. Premature ovarian failure (failure of ovulation in woman younger than 40 years of age);
      2. Gonadal dysgenesis including Turner syndrome;
      3. Bilateral oophorectomy;
      4. Ovarian failure following chemotherapy or radiotherapy;
      5. In vitro fertilization treatment failure.

      6. High risk of transmitting a genetic disorder from the female partner to the offspring.

      Note: Many Aetna plans that otherwise cover infertility services exclude coverage of fees associated with oocyte donation, including recruitment and selection of donors, ovarian stimulation of donors, collection of oocytes from donors, and screening and storage of donor oocytes. Please check benefit plan descriptions for details. Under plans with benefits for in vitro fertilization that have this exclusion, medically necessary in vitro fertilization services are covered only once an embryo is created from the donor egg.

   6. Cryopreservation of oocytes or ovaries is considered experimental and investigational. In addition, such cryopreservation is not considered treatment of disease.

Note: A cycle of ART defined in the CPB may be any of the following: IVF (with fresh embryos), IVF/frozen embryo transfer, GIFT or ZIFT.

See also: CPB 323 - Preconceptional Sex Selection Techniques; CPB 189 - Genetic Counseling.

Appendix

Laboratory Services:

The following numbers of laboratory services per cycle are considered medically necessary.

Key: IUI - intrauterine insemination; Inj - injection; Mon - monthly; IVF - in vitro fertilization; GIFT - gamete intrafallopian transfer; FET - frozen embryo transfer; PM - pregnancy monitoring; FSH - follicle stimulating hormone; LH - luteinizing hormone; hCG - human chorionic gonadotropin.

*Note: More than two progesterone measurements may be medically necessary for infertile women with irregular and prolonged menstrual cycles. For infertile women with regular menstrual cycles, a mid-luteal serum progesterone measurement (day 21 of a 28-day cycle) is considered medically necessary. For infertile women with irregular menstrual cycles, this test would need to be repeated at the mid-luteal phase and weekly thereafter until the next menstrual cycle starts.

Definitions:

For purposes of this policy, the following definitions will be used:

Classification of ovulatory disorders:

Anovulation and oligo-ovulation are ovulatory disorders that are estimated to cause 21% of female fertility problems. The World Health Organization classifies ovulation disorders into three groups.

• Group I: hypothalamic pituitary failure (hypothalamic amenorrhea or hypogonadotrophic hypogonadism).
• Group II: hypothalamic pituitary dysfunction (predominately polycystic ovary syndrome).
• Group III: ovarian failure.

Embryo Quantity and Quality in ART Cycles:

Embryo quantity and quality are considered adequate if an ART cycle produces 3 or more embryos for transfer, each of which are at least 6 to 8 cells (for day 3 transfers) of reasonable quality (grade B or its equivalent) with less than 50 percent fragmentation.

Fertilization Rates in IVF Cycles:

Fertilization rates are considered poor if IVF cycles result in less than 50 percent fertilization.

Ovarian Reserve in Response to Gonadotropin Stimulation:

Ovarian reserve is considered normal if three or more follicles develop and estrogen levels are greater than 500 mIU/ml following ovarian hyperstimulation with gonadotropins. Diminished ovarian reserve is indicated by peak estrogen levels less than 500 mIU/ml or fewer than 3 mature follicles are available at the time of stimulation and retrieval.

Semen Quality and Quantity:

Deficits in semen quantity are considered severe if there are less than 10 million total motile sperm per ejaculate (unwashed specimen) or less than 3 million total motile sperm (washed specimen) on two separate occasions at least 2 weeks apart. Deficits in semen quality are considered severe if there are less than 4 percent normal forms using Kruger strict morphology.

No fertility treatment other than oocyte donation has been shown to be effective for women over 40 years of age with compromised ovarian reserve.  Elevated FSH and estradiol levels are independent predictors of poor prognosis in older women.  Common criteria for normal ovarian reserve are an early follicular phase FSH level of less than 10 mIU/ml and an estradiol level of less than 80 pg/ml (ASRM, 2002).  Higher cut-off values for FSH have been reported (as high as 20 to 25 mIU/ml for FSH) because of the use of different FSH assay reference standards.  Women with diminished ovarian reserve experience decreased responses to ovulation induction, require higher doses of gonadotropin, have higher IVF cycle cancellation rates, and experience lower pregnancy rates through IVF.