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Rec-FSH Plus GnRH-Antagonist Associated With Increased Clinical Pregnancy Rates: Presented at ASRM

By Deborah Brauser

ATLANTA -- October 25, 2009 -- A treatment combination of recombinant follicle stimulating hormone (rec-FSH) and a flexible initiation of gonadotropin releasing hormone (GnRH)-antagonist is associated with higher clinical pregnancy and live birth rates than rec-FSH alone or with a fixed-start GnRH, according to an ongoing prospective study presented here at the 65th Annual Meeting of the American Society for Reproductive Medicine (ASRM).

Lead author Laurel Stadtmauer, PhD, Jones Institute for Reproductive Medicine at Eastern Virginia Medical School, Norfolk, Virginia, announced the interim results here on October 21.

With a goal of evaluating the effects of a GnRH-antagonistic in gonadotropin-stimulated patients with anovulatory polycystic ovary syndrome (PCOS), the investigators enrolled 154 women undergoing ovulation induction cycles with intrauterine insemination.

"A problem with women with PCOS is that a number of them are difficult to stimulate and don't respond at all until you increase the dose and then they may overstimulate," said Dr. Stadtmauer. "Many of these women have higher testosterone levels and elevated luteinising hormones [LH], and many are obese."

"So we wanted to see if adding a GNRH-antagonist, which is a medication that decreases LH, would be beneficial in increasing pregnancy rates."

The patients, who had an average body mass index (BMI) of 29 to 31, were randomised to receive either a treatment with rec-FSH alone (group 1, n = 53), the rec-FSH plus a GnRH-antagonist added once follicle size reached 13 mm in diameter (group 2, n = 54), or the rec-FSH plus the GnRH-antagonist added from the first day of stimulation (group 3, n = 47).

The clinical pregnancy rate per cycle initiated was the primary outcome, with live birth and premature luteinisation rates secondary.

The results showed a higher clinical pregnancy rate in group 2 at 35.1% versus 22.6% in group 1 and 21.33 in Group 3 (P = .1).

Group 2 also had a higher live birth rate at 33% versus 19% and 15% in groups 1 and 3, respectively (P = .07) and a similarly higher live birth rate per cycle completed at 35% versus 20% and 18% (P = .15).

Premature luteinisation occurred significantly more in group 1 at 20% versus 0% in group 2 and 2% in group 3 (P < .05). "This makes sense as group 1 was the one that did not have the antagonist," explained Dr. Stadtmauer.

In addition, all pregnancies were singletons except for 2 sets of twins in group 2.

"These interim results show a clear trend for improved primary outcome in the flexible antagonist group," said Dr. Stadtmauer.

"There are 2 important takeaways from this study. One is that in women with PCOS, ovulation induction is an alternative to IVF. If you give low dose treatment with careful monitoring, you can achieve decent pregnancy rates."

"Second, it appears that the GnRH-antagonist might be the preferred treatment in these women by decreasing premature luteinisation rate and the LH levels," Dr. Stadtmauer concluded.

[Presentation title: Randomized Controlled Trial Evaluating the Effect of a GnRH-Antagonist in Women With PCOS Undergoing Ovulation Induction With Gonadotropins and Intrauterine Insemination (IUI): Interim Analysis. Abstract O-274]

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