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

Completed

• Conditions: Frozen-thawed Embryo Transfers; Ovarian Hyperstimulation Syndrome
• Interventions: Other: Identification of predictive factors

• Registration Number: NCT05588635
• Lead Sponsor: Centre Hospitalier Régional Metz-Thionville

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-01
• Primary Completion: 2021-03-01
• Study Completion: 2021-03-01
• Status Verified: 2022-10
• Study First Submitted: 2022-10-10
• Study First Submitted QC: 2022-10-17
• Last Update Submitted: 2022-10-17
• Study First Posted: 2022-10-20
• Last Update Posted: 2022-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 168

Inclusion Criteria

• women between 18 and 43,
• having frozen-thawed single embryo transfer of a day-5 blastocyst with hormonal replacement therapy, with measurement of serum progesterone on the day of transfer

Exclusion Criteria

• frozen-thawed transfer of a day-2 or -3 or -6 embryo,
• double embryo transfer,
• other protocol than HRT,
• patient without serum progesterone measurement on the day of transfer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
With live birth group	Identification of predictive factors	patients with live birth following frozen-thawed embryo transfer
Without live birth group	Identification of predictive factors	patients without live birth following frozen-thawed embryo transfer

Primary Outcome Measures

Name	Time	Method
Identification of factors on the embryo transfer day that predict live birth after frozen-thawed embryo transfer	On the day of embryo transfer (Day 0)	The following variables were compared between groups: 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).

Secondary Outcome Measures

Name	Time	Method
Pregnancy status	12 days after embryo transfer (Day 12)	Pregnancy status (yes/no)
Serum progesterone	12 days after embryo transfer (Day 12)	Measurement of serum progesterone (ng/ml)

Trial Locations

Locations (1)

CHR Metz-Thionville/Hopital de Mercy; 🇫🇷 Metz, France