Conditions: Female Infertility
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1070
Healthy volunteers: no

Brief summary:
Female inability to conceive a child. The purpose of this randomized, two-arm and double blind, double dummy study is to demonstrate that the treatment of a daily dose of 3x10mg dydrogesterone orally is as effective and safe as the daily dose of 3x200 mg micronized progesterone capsules administered intravaginally for the luteal support in patients 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 after treatment until 30 days after delivery to record any safety and tolerability data of the patient and their newborn(s).

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Dydrogesterone 30 mg intervention 2: Micronized Progesterone 600 mg intervention 3: Placebo progesterone intervention 4: Placebo dydrogesterone
Intervention descriptions: intervention 1: Oral Dydrogesterone 10 mg tablets tid intervention 2: Intravaginal micronized progesterone 200 mg capsules tid intervention 3: Placebo intravaginal micronized progesterone 200 mg capsules tid intervention 4: placebo oral dydrogesterone 10 mg tablets tid

Protocol document: