Female Infertility Clinical Trial
Official title:
A Randomized, Open-label, Two-arm, Multicenter Study Comparing the Efficacy, Safety and Tolerability of Oral Dydrogesterone 30 mg Daily Versus Crinone 8% Intravaginal Progesterone Gel 90 mg Daily for Luteal Support in In-Vitro Fertilization (LOTUS II)
The purpose of this randomized, two-arm and open label study is to demonstrate that the
treatment of a daily dose of 3x10mg dydrogesterone orally is as effective and safe as the
daily dose Crinone 8% intravaginal progesterone gel 90 mg for the luteal support in women who
are unable to conceive a child and are undergoing IVF. The treatment will start on the day of
oocyte retrieval and continue until pregnancy is negative or until week 12 gestation.
Patients will be followed during treatment until 30 days after delivery to record any safety
and tolerability data of the patient and their newborn (s).
"This article has been accepted for publication in Human Reproduction published by Oxford University Press." ;
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