The Rescue of Hormonal Replacement Frozen Embryo Transfer Cycle With Low Serum Progesterone.
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
Frozen embryo transfer (FET) is increasingly adopted strategy in modern IVF. Among the many
factors that have contributed to such change, the pursuit of an ovarian hyperstimulation
syndrome free clinic has been strongly required. Improvements in the vitrification and
warming processes and the excellent cryo-survival rates have turned FET in our main tool for
preventing this complication. Moreover, a freeze all strategy has proven to provide excellent
or even better pregnancy rates (PRs), not only in high but also in normal responders.
While ART have rapidly evolved in the areas of embryo culture, vitrification and
understanding of the embryo development, little progress has been achieved regarding
endometrial preparation for FET. Undoubtedly, correct implantation requires a good quality
embryo and a suitable decidualized endometrium. Artificial cycles require hormone replacement
treatment (HRT) with estradiol and progesterone (P4). However, there is not a single
standardized treatment described for optimal endometrial preparation and no protocol has
proven superiority in terms of reproductive outcomes.(5, 6) Although artificial preparation
is the most convenient method to schedule FET cycles, recent reports have highlighted a
potentially detrimental effect of low P4 levels prior to FET on miscarriage and live birth
rates (LBRs). These results have been observed both in homologous and oocyte recipient FET
cycles(7, 8), but also in FET cycles of embryos that had undergone PGT for aneuploidies
(PGT-A).(9) Additional P4 supplementation may be a way to improve reproductive outcomes in
these patients.
Our open labelled randomized control study aims to investigate whether patients with low
serum P4 levels the day before FET under standard HRT can benefit in terms of clinical and
ongoing pregnancy and implantation rates from an individualized luteal phase support
consisting in the addition of oral dydrogesterone supplementation or daily subcutaneous P4
injection.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
El Shatby University Hospital for Obstetrics and Gynecology