Oral Versus Vaginal Progesterone in the Luteal Support in Cryo-warmed Embryo Transfer Cycles
Status:
Recruiting
Trial end date:
2021-08-01
Target enrollment:
Participant gender:
Summary
In IVF/ICSI cycles, the progesterone levels induced by ovarian stimulation are low, therefore
the luteal phase is supported by progesterone. The use of progestogens in IVF is associated
with an improvement in the live birth rate Standard protocol for luteal phase support has not
yet been established. Currently vaginal progesterone is widely used, since the classic oral
progesterone seems to result in a low bioavailability and a lower pregnancy rate. However,
vaginal administration of progesterone is associated with vaginal irritation, discharge and
bleeding. For all these reasons, there is a need for an effective, well tolerated, and safe
treatment that can improve patient satisfaction and compliance.
Many studies have observed similar pregnancy rate results with dydrogesterone and micronized
vaginal progesterone. A new RCT including a total of 1143 patients by Tournaye, showed that
dydrogesterone treatment had a similar safety profile to micronized vaginal progesterone
(MVP) for luteal support as part of ART treatment. The crude pregnancy rates at 12 weeks were
37.6% and 33.1% in the dydrogesterone and MVP treatment groups respectively.
Regarding the administration route of progesterone, intramuscular and transvaginal routes are
the two conventional progesterone administration techniques. However, very few studies have
compared the advantages of oral dydrogestrone with vaginal progesterone for luteal support in
ART cycles.
The objective of the investigator's study is to demonstrate the superiority of oral
dydrogesterone (Duphaston) 10 over MVP (Utrogestan) used for luteal supplementation in
cryo-warmed embryo transfer cycles. Upon consent, 224 patients women will be randomly
allocated into either one of the study groups using a simple randomization method by
computer-generated random numbers. Group I will receive the oral dydrogesterone, while group
II will receive the vaginal microprogesterone.