unexplained infertility

Although up to 10% of infertile couples are diagnosed with idiopathic or “unexplained infertility”, “infertility” is generally diagnosed when conception does not occur after one year of unprotected intercourse in couples where the woman is under age 35. Where the woman is 35 or older, the diagnosis of infertility is usually made once a couple has been trying to become pregnant for only six months. This distinction is based on data suggesting that a woman’s reproductive potential declines after the age of 35.

“Unexplained” means that a conventional battery of fertility tests for both partners has failed to reveal a cause of infertility.

determining the facts

Individual healthcare providers differ as to what constitutes a conventional panel of infertility tests. After reviewing the medical history and completing a physical examination, they may include the following:

For women:

• Blood hormone levels
• Ovulatory function tests
• Post-coital tests
• Transvaginal ultrasound
• Hysterosalpingogram (HSG) (x-ray of uterus and fallopian tubes using radio-opaque dye)
• Laparoscopy (tiny telescope inserted into abdomen to examine uterus, ovaries, fallopian tubes)

For Men:

• Hormone tests
• Semen analysis
• Additional tests for sperm motility, sperm penetration capacity, antibodies, blockage or infections

how is it treated?

Just as the tests used to diagnose unexplained infertility vary according to the healthcare provider, so too do the treatments offered for that condition. The following treatments may be recommended:

• Ovulation induction drugs, such as clomiphene citrate; sometimes human menopausal gonadotropins (hMG) or follicle-stimulating hormone (FSH) drugs such as Follistim® AQ Cartridge (follitropin beta injection)
• Intrauterine insemination (IUI) (artificial insemination of sperm into the uterus)
• In vitro fertilization (IVF) (eggs and sperm are combined in a laboratory, then fertilized eggs/embryos are transferred into the uterus)

The emotional reaction to a diagnosis of unexplained infertility can be difficult and frustrating, since couples start testing with the expectation that the test results will reveal a cause for their infertility problem. It is not uncommon for couples to relentlessly pursue their search for answers and some couples have great difficulty deciding when to discontinue treatment.

Follistim^® AQ Cartridge (follitropin beta injection) is approved to help women who have problems with ovulation. Follistim^® AQ Cartridge will not help women whose ovaries do not work at all (primary ovarian failure). Follistim^® AQ Cartridge is also for women that are in an assisted reproductive technology (ART) program, such as in vitro fertilization.

Important Safety Information

Always follow your health care professional’s dosing instructions when administering Follistim^® AQ Cartridge. Your health care professional has individualized the dose to be administered based on your medical history. Do not change your dose unless instructed by your health care professional.

Do not use Follistim^® AQ Cartridge if you are allergic to recombinant human FSH products; have primary ovarian failure (your ovaries do not work at all); are pregnant or think you might be pregnant; have uncontrolled thyroid or adrenal gland problems; have tumors in your ovaries, breasts, uterus, hypothalamus, or pituitary gland; have heavy or irregular vaginal bleeding and the cause is not known; have ovarian cysts or enlarged ovaries not due to polycystic ovary syndrome (PCOS); or are allergic to streptomycin or neomycin. Follistim^® AQ Cartridge may contain traces of these antibiotics and may cause allergic reactions.

Follistim^® AQ Cartridge may cause ovarian hyperstimulation syndrome (OHSS), which is a serious medical problem that can happen when the ovaries are overstimulated. In rare cases it has caused death. OHSS causes fluid to build up suddenly in the stomach and chest areas. OHSS may occur after treatment with Follistim^® AQ Cartridge. Call your health care professional right away if you get any of the following symptoms: severe pelvic pain (lower stomach area), nausea, vomiting, sudden weight gain, or reduced urine output.

Follistim^® AQ Cartridge and other FSH products may cause serious lung problems including fluid in the lungs, trouble breathing, and worsening of asthma. Follistim^® AQ Cartridge and other FSH products may also cause blood clots in blood vessels. This can lead to blood vessel problems (thrombophlebitis), stroke, loss of limb, or a blood clot in the lung (pulmonary embolus).

Follistim^® AQ Cartridge and other FSH products can cause multiple births. Your health care professional will discuss your chances of multiple births.

Follistim^® AQ Cartridge should only be prescribed by physicians experienced in infertility treatments.

Other side effects with Follistim^® AQ Cartridge include stomach pain, gas, pelvic pain, nausea, breast pain, injection site problems, enlarged stomach area, back pain, constipation, headache, and ovarian pain. If you get any side effects that concern you, call your health care professional. These are not all the side effects of Follistim^® AQ Cartridge. Contact your doctor or other health care professional without delay if you are experiencing symptoms including significant abdominal pain or if symptoms develop some days after the last injection has been given.

Please click here for important Product Information, or click here for the Follistim^® AQ Cartridge Patient Information leaflet.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088