Bleeding Is Rare In IVF Patients Who Become Pregnant When Treated With A Combination Of Vaginal Progesterone Gel And Estrogen

Main Category: Pregnancy / Obstetrics
Also Included In: Blood / Hematology;  Fertility
Article Date: 23 Oct 2009 - 6:00 PDT

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A prospective, multi-center study demonstrated that in IVF (in vitro fertilization) cycles supplemented with once-daily dosing of Crinone® vaginal progesterone gel and Estrace® oral estrogen, vaginal bleeding is rare in patients who become pregnant. Bleeding does occur in approximately one-quarter of patients who do not become pregnant. These data were presented at the American Society for Reproductive Medicine (ASRM) annual meeting in Atlanta.

Vaginal bleeding is reported in some IVF cycles during the luteal phase (the end of a woman's menstrual cycle, when progesterone levels are significantly higher), and can be a major concern for women undergoing infertility treatment. This study, including 66 patients who became clinically pregnant and 53 patients who did not conceive, evaluated the effectiveness of the combination of Crinone with estrogen on luteal phase bleeding.

In a podium presentation, James P. Toner, MD, PhD, Atlanta Center for Reproductive Medicine, demonstrated that 36% of patients had spotting or bleeding associated with egg retrieval. No more than two (5%) of the pregnant patients bled on any day past egg retrieval. The combination of vaginal progesterone gel and estrogen appears to reduce the incidence of bleeding in IVF patients who become pregnant.

"By treating IVF patients with a combination of Crinone and Estrace, we may succeed in eliminating bleeding in those who achieve pregnancy and reduce the level of stress and concern for patients during this stage of their treatment cycle," stated Dr. Toner. "We are continuing to collect data, including data from other centers that use either intramuscular progesterone or do not supplement their Crinone cycles with estradiol, to determine if bleeding rates are different with these other strategies for luteal support."

This study was supported by a grant from Columbia Laboratories (Nasdaq: CBRX).

About Progesterone and Luteal Phase Support

Progesterone is a hormone naturally found in a woman's body, which creates a healthy environment in the uterus, where a fertilized egg can implant and grow into a healthy pregnancy. Most women undergoing infertility treatment need additional progesterone, to help prepare the uterus for implantation and development of a fertilized egg.

Before ovulation, progesterone levels in a woman's body remain relatively low, but rise after ovulation, during the luteal phase. The luteal phase is the latter part of a woman's menstrual cycle. It begins with the production of progesterone and ends with either pregnancy or menstruation, when the uterus sheds its lining. During pregnancy, progesterone helps to maintain the lining of the uterus, providing necessary nutrients to support and nurture a fertilized egg.

About CRINONE® 8%

CRINONE ® 8% was the first FDA-approved natural progesterone for progesterone supplementation or replacement as part of Assisted Reproductive Technology (ART) treatments for infertile women with progesterone deficiency, and is the only once a day treatment. CRINONE 8% is safe for use during pregnancy, and has been safely used for a decade by tens of thousands of women globally to help sustain pregnancy in the first trimester. Its unique bioadhesive delivery system provides controlled and sustained release of progesterone directly where it is needed. For more information, please visit http://www.crinoneusa.com.

The most common side effects of CRINONE 8% include breast enlargement, constipation, somnolence, nausea, headache, and perineal pain. CRINONE 8% is contraindicated in patients with active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders, missed abortion, undiagnosed vaginal bleeding, liver dysfunction or disease, and known or suspected malignancy of the breast or genital organs.

Source
Columbia Laboratories