Vaginal progesterone gel is equally effective as hormone injection in infertility treatment: Study

Vaginal progesterone gel is equally effective as intramuscular hormone injection in infertility treatment, according to large new clinical study.

The results from the largest prospective, randomized clinical study compared vaginal progesterone to intramuscular progesterone injections (IM progesterone) for luteal support in infertility treatment.

The study which used Crinone vaginal progesterone gel showed that vaginal progesterone is equally effective and significantly better tolerated than IM progesterone for luteal phase support in In Vitro Fertilization and Embryo Transfer (IVF-ET) cycles.

“Last year, over 70% of the progesterone used in fertility and Ob/Gyn practices was intramuscular. However, I predict that in 2010 we will see vaginal administration as the preferred route of administration,” Paul W. Zarutskie, MD, an authority on luteal phase support in IVF from the Zarutskie Fertility and Endocrine Institute, was quoted as saying.

The time has come to change the paradigm for the administration of progesterone in luteal support and early pregnancy support to vaginal gel, Dr. Zarutskie stated.

Intramuscular progesterone injections have been the standard form of luteal phase support in IVF for decades. Intramuscular progesterone injection is considered painful and inconvenient and causes irritation of tissues, infections, and occasionally even more serious pulmonary complications. Hence, it was highly desirable to find an alternative more comfortable route of progesterone supplementation, but without compromise to pregnancy rates, experts said.

Data from the study were presented by researchers from Brigham & Women’s Hospital in Boston at the annual meeting of the American Society for Reproductive Medicine (ASRM).

In the study, over 400 participants were randomized to receive Crinone or IM progesterone, 48 or 24 hours after egg retrieval, respectively. No differences were observed between Crinone and the IM progesterone groups in overall pregnancy rates, implantation, ongoing pregnancy or failed pregnancy rates. Patients were also surveyed at the completion of the cycle, and reported that Crinone was significantly better tolerated than IM progesterone.

The study was supported in part by a grant from Columbia Laboratories, Inc.

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.

Columbia Laboratories Columbia Laboratories, Inc. is a specialty pharmaceutical company focused on developing and commercializing products for the women’s healthcare and endocrinology markets that use its novel bioadhesive drug delivery technology.