Phase III trial of 8% vaginal progesterone gel for luteal phase support in Japanese women undergoing in vitro fertilization and fresh embryo transfer cycles.

ABSTRACT:

Aim

This study evaluated the efficacy and safety of vaginal progesterone gel that was administered daily for luteal phase support as part of in vitro fertilization/embryo transfer (IVF/ET) cycles in Japanese women.

Methods

This was a phase III, multicenter, open-label, single-arm trial in Japanese women undergoing IVF/ET, using the Japanese Society of Obstetrics and Gynecology 2009 registry as a historical control. The primary objective was to demonstrate the non-inferiority, with regard to the clinical pregnancy rate per ET, of vaginal progesterone gel that was administered once daily, compared with the historical standard value in IVF/ET cycles in Japan. The biochemical pregnancy (positive serum β-hCG pregnancy test but no clinical pregnancy) rate per ET also was investiga

SUBMITTER: Kokeguchi S 

PROVIDER: S-EPMC5715867 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature