Effect of Intervention on Progesterone Levels Before Euploid Embryo Transfer in Pregnancy Outcomes.
Status:
Completed
Trial end date:
2020-02-28
Target enrollment:
Participant gender:
Summary
Transferring an euploid embryo avoids one of the main reasons of miscarriage and implantation
failure (1), overcoming confounding factors such as embryo ploidy or maternal age. Frozen
Euploid Embryo Transfer (FEET) is routinely performed under standard hormone replacement
therapy (HRT) and could be considered the best model for evaluating the impact of the
endometrial preparation in clinical pregnancy rate and also in miscarriage rate.
Recently several authors have paid attention to serum progesterone (P) as a possible factor
influencing Frozen Embryo Transfer (FET) outcomes. P plays an important role in endometrial
gland formation, embryonic implantation and pregnancy maintenance. Labarta et al. (2)
described in blastocyst FET performed under HRT that serum P <9.2 ng/mL measured on the
transfer day is associated to significantly lower ongoing pregnancy rate (OR 0.297, 95%
CI:0.113-0.779).
Recently the investigators have analyzed 244 FEET performed under HRT in a retrospective
study (3). Preimplantation genetic testing for aneuploidies (PGT-A) was carried out as
previously described (4). Embryos that reached the blastocyst stage were biopsied and frozen
immediately afterwards using the vitrification method (5). Euploid embryos were transferred
in a subsequent cycle under HRT. Serum P was analyzed the day previous to FEET. Patients with
serum P <10.6 ng/mL had significantly higher miscarriage rate (26.6% vs 9.5%, p=0.007) and
lower live birth rate (47.5% vs 62.3 %, p= 0.029) than those with serum P >10.6 ng/mL. The
investigators also observed that patients with serum P >13.1 ng/mL had the lowest miscarriage
rate (9.1%) and the highest live birth rate (65.6%). The worst outcomes were observed when
serum P was <8.06 ng /mL (41% live birth rate and 32.4% miscarriage rate).
As miscarriage was higher among FEET cycles with serum P <10.6 ng/ml, the investigators
hypothesize that altering the progesterone supplementation scheme could potentially reduce
miscarriage rates and increase live birth rate. The purpose of this study is to modify the
standard progesterone supplementation in FEET under HRT (vaginal micronized progesterone 200
mg every 8 hours) (6) according to serum P measured not only on the day prior to transfer but
also on Beta subunit of Human Chorionic Gonadotropin (β-hCG) analysis day, and to probe if
this intervention reduces miscarriage rate and increases pregnancy outcome.
Phase:
N/A
Details
Lead Sponsor:
Institut Universitari Dexeus
Collaborators:
Dexeus Clinic Woman Dexeus Mujer Fundación Santiago Dexeus Font