NCT05588635

Association Between Live Birth Rate and Serum Progesterone During Hormonal Replacement Therapy

Association Between Live Birth Rate and Serum Progesterone on Frozen-thawed Embryo Transfer Day: Retrospective Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 168 (actual)
• Sponsor: Centre Hospitalier Régional Metz-Thionville · Academic / Other
• Sex: Female
• Age: 18 Years – 43 Years
• Healthy volunteers: Not accepted

Summary

Nowadays, frozen-thawed embryo transfers (FET) are expending. This practice avoids risk of ovarian hyperstimulation syndrome (OHSS), as well as allowing better synchronization between endometrium and embryo, which is fundamental for pregnancy. There are several FET protocols, including hormonal replacement therapy cycle (HRT), which enable clinicians to adapt the day of embryo transfer. However, increase in spontaneous miscarriages was observed with this latter protocol compared to fresh embryo transfers and the other endometrial preparations (natural and stimulated), in relation with the lack of physiological corpus luteum. Then, Clinicians interrogate about measuring serum progesterone in order to adjust their treatment and/or transfer date. Various studies have shown thresholds below and/or above which pregnancy or live birth rate were lowered. The main objective is to find a serum progesterone threshold on the day of embryo transfer above which live birth rate is increased. The secondary objectives are to analyze the factors associated with increased serum progesterone on the day of transfer, to analyze the miscarriage rate, and impact of change on luteal phase support on day 12.

Conditions

• Ovarian Hyperstimulation Syndrome
• Frozen-thawed Embryo Transfers

Interventions

Type	Name	Description
OTHER	Identification of predictive factors	Evaluation of the following variables : mother age (years), father age (years), serum progesterone (ng/ml), mother body mass index (kg/m2), serum Antimüllerian hormone (AMH) (ng/ml), infertility etiology (yes/no): 4 categories: idiopathic etiology, mixed origin infertility, male infertility, female infertility; smoker status among mothers (yes/no).

Timeline

• Start date: 2019-11-01
• Primary completion: 2021-03-01
• Completion: 2021-03-01
• First posted: 2022-10-20
• Last updated: 2022-10-20

Locations

1 site across 1 country: France