A multi-center, randomized, open-label, parallel group study of a natural micronized progesterone vaginal tablet as a luteal support agent in Japanese women undergoing assisted reproductive technology.

ABSTRACT:

Purpose

To verify sufficient progesterone supplementation during the luteal phase and to determine the efficacy and safety of a natural micronized progesterone vaginal tablet (FE 999913) in Japanese women undergoing in vitro fertilization-embryo transfer or intracytoplasmic sperm injection.

Methods

In a multi-center, randomized, open-label, parallel group trial, 108 subjects were randomized to receive FE 999913 vaginally twice daily (n = 54) or three times daily (n = 54) for up to 10 weeks. Primary endpoints were the proportion of subjects with serum progesterone concentration ≥10 ng/ml on day 5 and ongoing pregnancy rate at week 5.

Results

Ninety-four subjects completed the trial and 90 subjects underwent embryo transfer. The proportion of subjects with

SUBMITTER: Fujiwara T 

PROVIDER: S-EPMC4592497 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature