Vaginal gel versus intramuscular progesterone for luteal phase supplementation: a prospective randomized trial

Abstract

The aim of this randomized study was to compare the efficacy of intramuscular progesterone (IMP) and progesterone in vaginal gel (VGP) at two different doses for luteal support in IVF. A total of 412 patients, aged between 28 and 37 years, were randomized into three groups. The day after oocyte retrieval each patient began supplementation with one of the following: IMP 50 mg daily (150 patients), VGP 90 mg once daily (143 patients), or VPG 90 mg twice daily (148 patients). No significant difference was found between the three groups in any of the endpoints. The rate of positive beta-human chorionic gonadotrophin per transfer was 38.4% with IMP, 35.0% with VPG once daily and 43.1% with VPG twice daily. Clinical pregnancy rate per transfer and implantation rate were 32.6% and 19.6% with IMP, 26.3% and 16.4% with one dose of VGP, and 37.2% and 21.1% with two doses of VGP. Live birth rate per transfer was 26.1%, 23.4% and 29.9%, respectively. Progesterone vaginal gel can be successfully used as an alternative to intramuscular progesterone for luteal support in IVF. One daily dose appears sufficient to induce clinical pregnancies and live births at a rate comparable to intramuscular supplementation.

Vaginal (Crinone 8%) gel vs. intramuscular progesterone in oil for luteal phase support in in vitro fertilization: a large prospective trial

“…Although there was a trend toward higher pregnancy, delivery, and implantation rates with the vaginal gel administered twice daily, these differences were not statistically significant (19). In a large prospective, randomized trial, Yanushpolsky showed similar results between Crinone and IMP in 407 patients (7).…”

“…Despite desire on the part of patients to replace IMP, physicians have been reluctant to change protocols, presumably because of concern that alternative formulations will not be able to deliver the same success rates. Many recent studies have suggested at least equivalent efficacy between vaginal P and IMP (8,18,19).…”

Comparison of oral dydrogestrone with progesterone gel and micronized progesterone for luteal support in 1,373 women undergoing in vitro fertilization: a randomized clinical study

“…Progesterone vaginal gel can be successfully used as an alternative to IM P for luteal support in IVF. One daily dose seems sufficient to support clinical pregnancies and live births at a rate comparable to IM supplementation (26).…”

The efficiency of progesterone vaginal gel versus intramuscular progesterone for luteal phase supplementation in gonadotropin-releasing hormone antagonist cycles: a prospective clinical trial

“…The investigators commented that the increased luteal phase bleeding with vaginal P 4 occurred in unsuccessful IVF cycles without a viable pregnancy. A prospective randomized study compared the efficacy of IMP (50 mg) and PVG at two different doses (Crinone 8% once daily or twice daily) for luteal support in IVF (19) and concluded that PVG at one daily dose appeared sufficient to induce clinical pregnancies and live births at a rate comparable with IMP. Although the onset of bleeding in patients who had a negative b-hCG test was not included as one of the end points of their study, the investigators evaluated this feature in a subgroup of patients for whom the data were available and found an incidence of bleeding before the b-hCG test that was similar in the two vaginal gel groups (single vs. double dose: 71.6% in single dose and 64.1% in double dose), but statistically significantly higher (P<.001) than in the IMP group (32.7%).…”