Assisted Reproductive Technologies

Assisted Hatching

Before implanting in the uterus, an embryo must first emerge from its protective covering, much like a baby chick emerges from an egg. This process is called hatching.

In some women, this protective membrane seems to harden, particularly as they age. This can interfere with the hatching process. In these cases, thinning the embryo membrane with a diluted acidic solution or laser before embryo transfer can help the hatching process. It may increase the chance of pregnancy in older women or those who have not achieved pregnancy after several in vitro fertilization (IVF) cycles. Assisted hatching may also be done in some cases following cryopreservation ("egg freezing") and embryo thawing.

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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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