Medication

Understanding Hormone Therapy

Sometimes, hormone therapy is needed to help a woman's ability to conceive.

The type of medicine used depends upon which phases of the infertility treatment cycle you are in. It's a relatively common treatment.

A woman usually receives hormone therapy while she undergoes either ovulation induction (OI) or assisted reproductive technologies (ART) treatments.

Follicular phase

During the first 13 days of a woman's cycle, follicles in her ovaries begin to produce a single mature egg. During this phase, Gonal-f® (follitropin alfa for injection), a follicle stimulating hormone (FSH), may be prescribed to help stimulate the development of the follicles. If a woman has been diagnosed with profound luteinizing hormone (LH) deficiency (less than 1.2 IU/liter), Luveris® (lutropin alfa for injection), an LH, may also be prescribed to aid in stimulating follicular development in profoundly LH-deficient hypogonadotropic hypogonadal (HH) women (LH< 1.2 IU/L).

Throughout the cycle, timing is very important. During this phase, a woman's body releases a hormone called estradiol. If the level of estradiol gets too high too early, it can trigger a premature surge of LH that leads to early ovulation. So Cetrotide® (cetrorelix acetate for injection) may be used in controlled ovarian stimulation to delay this surge until the developing follicles are ready. Around the 11th day, treatment with Gonal-f® is stopped and the woman may receive a single injection of Ovidrel® PreFilled Syringe (choriogonadotropin alfa injection). Ovidrel® PreFilled Syringe mimics the surge of LH, which triggers the final step in the follicular phase. The hormone in Ovidrel® PreFilled Syringe causes the final maturation of the eggs and their release from the ovaries. This is called ovulation.

If the woman is undergoing OI, this is the time for intrauterine insemination (IUI). The sperm is inserted into the reproductive tract in an attempt to fertilize the egg.

In ART, if the woman is undergoing in vitro fertilization (IVF), the eggs are instead retrieved and brought together with the male's sperm in a laboratory in order to create an embryo.

Luteal phase

Once ovulation occurs, the body naturally begins releasing progesterone to prepare the endometrium (lining of the uterus) to receive the embryo.

Some women's bodies, however, don't produce enough progesterone on their own. Because of low progesterone, the endometrium may not develop the thick, nourishing lining required for pregnancy. As a result, an embryo cannot attach and get the nourishment it needs to develop. A woman may need a medication to supplement her own progesterone. This medication helps prepare and later maintain the uterine lining for the embryo.

During this phase, embryos created in the laboratory using IVF will be implanted into a woman's uterus. Medication such as progesterone will often continue after pregnancy is detected and until progesterone naturally produced by the placenta takes control of nurturing the pregnancy.

Important Safety Information
As with all prescription medications, side effects may occasionally occur with use of fertility drugs. Doctors specializing in fertility or reproductive health should only prescribe these products. Patients prescribed gonadotropins and GnRH analogs should be monitored carefully by a trained fertility specialist. Risks include the following events which can be serious: hypersensitivity reactions; ovarian hyperstimulation syndrome (OHSS); pulmonary and vascular complications, and multiple births. For complete product details about a specific fertility drug, please refer to the Full Prescribing Information offered below.

RFF: Revised Formulation Female

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Indication:
For women, Gonal-f® (follitropin alfa for injection), Gonal-f® RFF (follitropin alfa injection) and Gonal-f® RFF Pen (follitropin alfa injection) are indicated for 1) the induction of ovulation and pregnancy in the anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure and 2) for the development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program.
For men, Gonal-f® is also indicated for the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the main cause of infertility is not due to primary testicular failure.

Important Safety Information:
These products should only be prescribed by physicians specializing in fertility or reproductive health. Use of Gonal-f® or Gonal-f® RFF by women can result in multiple births. Patients should let their doctor know of any allergic reactions to recombinant FSH preparations or other product ingredients. Patients should also inform their doctor of a history of cancer of the sex organs or brain and uncontrolled thyroid or adrenal disease before starting or continuing treatment. Women with a history of abnormal bleeding from the uterus or vagina, swollen, enlarged, or painful ovaries should speak to their doctor before starting treatment. Gonal-f® and Gonal-f® RFF are potent gonadotropic substances capable severe adverse reactions, including Ovarian Hyperstimulation Syndrome (OHSS) in women, which can result hospitalization. Women should inform their doctor if they experience severe stomach pain, vomiting, bloating, or weight gain while taking Gonal-f® or Gonal-f RFF®. The most common side effects are headache, ovarian cysts, upset stomach, and sinus infections in women taking Gonal-f® or Gonal-f® RFF. The most common side effects in men taking Gonal-f® are skin acne, breast pain and growth, and tiredness. Needle injections may cause some discomfort.

For more information, refer to the prescribing and patient information offered below and talk to your doctor.


© EMD Serono, Inc. CIM Last Update 2008-09-16
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