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

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

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.

Study Overview

• Status: Completed
• Conditions: Ovarian Hyperstimulation Syndrome; Frozen-thawed Embryo Transfers
• Intervention / Treatment: Other: Identification of predictive factors

• Study Type: Observational
• Enrollment (Actual): 168

Contacts and Locations

Study Locations

• France
  • Metz, France, 57085
    • CHR Metz-Thionville/Hopital de Mercy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

patient having frozen-thawed single embryo transfer of a day-5 blastocyst with hormonal replacement therapy

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
With live birth group; patients with live birth following frozen-thawed embryo transfer	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).
Without live birth group; patients without live birth following frozen-thawed embryo transfer	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of factors on the embryo transfer day that predict live birth after frozen-thawed embryo transfer	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).	On the day of embryo transfer (Day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy status	Pregnancy status (yes/no)	12 days after embryo transfer (Day 12)
Serum progesterone	Measurement of serum progesterone (ng/ml)	12 days after embryo transfer (Day 12)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional Metz-Thionville
• Investigators: Principal Investigator: Ariane GOUTALAND, MD, CHR Metz Thionville Hopital de Mercy

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: October 10, 2022
• First Submitted That Met QC Criteria: October 17, 2022
• First Posted (Actual): October 20, 2022

Study Record Updates

• Last Update Posted (Actual): October 20, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: live birth rate; serum progesterone; frozen-thawed embryo transfer
• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Hyperstimulation Syndrome
• Other Study ID Numbers: 2022-05Obs-CHRMT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No