Randomized controlled study, open label to compare effectiveness of addition of dydrogesterone 20mg to the standard luteal phase support treatment after fresh embryos transfer.
In the context of IVF treatment, it's a standard of care to use progesterone for endometrial synchronization and for luteal phase support after embryos transfer and until week 9-12 of pregnancy. In Israel, as in most european countries, vaginal insert of Micronised Vaginal Progesterone (MVP) is mostly prescribed. Dydrogesterone is a potent active progesterone receptor agonist that is well tolerated, orally administered and is considered to be sufficiently safe during pregnancy. Based on recent publications, single oral dydrogesterone treatment seems to be a good option in clinical practice for luteal phase support in IVF cycles with fresh embryos transfer. But, until now, there is no publication evaluating the effectiveness of an addition of Dydrogesterone to the standard of care. The aim of the study is to compare effectiveness of addition of dydrogesterone 20mg to the standard luteal phase support treatment after fresh embryos transfer. The trial is a randomized controlled study, open label. Participants will receive either standard treatment with an addition of oral 10mg dydrogesterone (Duphaston) 2 times daily or the standard treatment without Dydrogesterone, starting on the day of fresh embryos transfer until 10 weeks of gestation or until pregnancy test is negative. Study participation will be proposed to every woman going through fresh embryos transfer in Laniado IVF unit, who meets the inclusion/exclusion criteria. The investigators aim to include 150 patients in each arm of the study, during 2 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
oral 10mg dydrogesterone (Duphaston) 2 times daily
Laniado Hospital
Netanya, Israel
Live birth rate
The percentage of live newborns in the total cycles of treatment
Time frame: 9 month
Presence of fetal heartbeats at 12 weeks of gestation
The percentage of pregnancies with heartbeats observed by ultrasound at 12 weeks in the total cycles of treatment
Time frame: 12 weeks
Frequency of positive pregnancy tests on Day 14 after embryo transfer
Time frame: 14 days
Rates of obstetrical complications
Obstetrical complications during pregnancy and labor. Examples- abruptio placenta, First trimester bleeding, Preterm Prelabor Rupture Of Membranes (PPROM), preterm labor
Time frame: 9 months
Newborn outcomes
Appearance, Pulse, Grimace, Activity and Respiration (APGAR) score- between 0-10. 10 is the best outcome. 0 is the worst outcome.
Time frame: 1 year
Newborn Weight
in grammes
Time frame: 9 months
Rates of Newborn malformations
Abnormal findings of physical examination of the newborn
Time frame: 1 year
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