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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
1,070
Oral Dydrogesterone 10 mg tablets tid
Intravaginal micronized progesterone 200 mg capsules tid
Placebo intravaginal micronized progesterone 200 mg capsules tid
placebo oral dydrogesterone 10 mg tablets tid
Site reference no. 113176
Vienna, Austria
Site reference no. 93593
Brasschaat, Belgium
Site reference no. 93598
Brussels, Belgium
Site reference no. 93615
Brussels, Belgium
Site reference no. 93617
Brussels, Belgium
Site reference no. 93613
Percentage of Participants Being Pregnant as Measured by the Presence of Fetal Heart Beats at 12 Weeks´Gestation Using Transvaginal Ultrasound
Percentage of participants being pregnant as measured by the presence of fetal heart beats at 12 weeks´gestation using transvaginal ultrasound
Time frame: 12 weeks´ gestation (at visit 6)
Percentage of Participants Being Pregnant as Measured by the Positive Biochemical Pregnancy Test on Day 14 After Embryo Transfer
Percentage of participants being pregnant as measured by the positive biochemical pregnancy test on Day 14 after embryo transfer
Time frame: Day 14 after embryo transfer
Percentage of Participants With a Successful Completion of Pregnancy
Incidence of live births and healthy newborns
Time frame: After delivery (about 9 months after IVF)
Gender of the Newborn
was recorded and collected for Newborn
Time frame: After delivery (about 9 months after IVF)
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Genk, Belgium
Site reference no. 93594
Ghent, Belgium
Site reference no. 93597
Ghent, Belgium
Site reference no. 93616
Hasselt, Belgium
Site reference no. 93595
Leuven, Belgium
...and 30 more locations