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Intravaginal Gel Better Tolerated Than Intramuscular Progesterone in IVF, as Effective: Presented at ASRM

By Deborah Brauser

ATLANTA -- October 25, 2009 -- Although a large new study showed no significant differences in overall pregnancy rates and other luteal phase outcomes between crinone vaginal gel and intramuscular progesterone (IMP) during in vitro fertilisation (IVF), it did find that the gel was significantly better tolerated.

The results were presented in a poster session on October 21 here at the 65th Annual Meeting of the American Society for Reproductive Medicine (ASRM).

"Traditionally, intramuscular progesterone has been the usual way that we supplement IVF cycles, and it's very unpleasant with the injections," said lead author Elena Yanushpolsky, MD, Department of Obstetrics/Gynecology, Brigham and Women's Hospital, and Reproductive Biology, Harvard Medical School, Boston, Massachusetts.

"That's why we were looking for a way to administer progesterone in a less painful way for the patient. However, we certainly never wanted to compromise the efficacy."

Dr. Yanushpolsky and colleagues compared both efficacy and patient satisfaction between crinone vaginal gel and IMP during IVF in women aged younger than 40 years and with day 3 follicle-stimulating hormone levels of <15 mIU/mL.

The researchers enrolled 468 patients who had fewer than 3 prior unsuccessful cycles, with 407 completing the study. The women were randomised to receive either the intravaginal gel (n = 206) 48 hours after oocyte retrieval or IMP injection (n = 201) 24 hours after retrieval.

Overall satisfaction was evaluated by phone surveys at cycle completion on a scale of 1 to 5, with 5 being most satisfied.

Although the results were somewhat higher for the gel-treated group than for the IMP group, there were no significant differences in overall pregnancy rates (66.5% vs 62.2%), implantation (36.9% vs 34.7%), ongoing pregnancy (45.2% vs 42.2%), or failed pregnancy (32.1% vs 32%).

However, the patients tolerated the crinone gel significantly better with a score of 4.4 (+- 0.9) vs 2.5 (+- 1.3) for those receiving IMP (P < .0001).

"This study was the largest prospective, randomised study to date to compare any vaginal progesterone to [IMP]," reported Dr. Yanushpolsky. "The results showed that the high efficacy and excellent patient tolerability of this intravaginal supplementation make it an optimal choice for luteal phase support in IVF cycles."

She added, "My hope is that clinicians will be convinced that intravaginal gel is the way to go for supplementation. And hopefully these results will provide enough evidence for them to consider changing protocols, as we have done in our program."

[Presentation title: Crinone Vaginal Gel Is Equally Effective and Better Tolerated Than Intramuscular Progesterone (IMP) for Luteal Phase Progesterone Support in IVF Cycles: A Prospective Randomized Study. Abstract P-551]

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