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

NCT05588635 | Completed

• 1 other identifier: 2022-05Obs-CHRMT
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Hyperstimulation Syndrome; Frozen-thawed Embryo Transfers

Keywords

serum progesterone; frozen-thawed embryo transfer; live birth rate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pregnancy status

  12 days after embryo transfer (Day 12)

• Serum progesterone

  12 days after embryo transfer (Day 12)

Study Arms (2)

With live birth group

patients with live birth following frozen-thawed embryo transfer

Other: Identification of predictive factors

Without live birth group

patients without live birth following frozen-thawed embryo transfer

Other: Identification of predictive factors

Interventions

Identification of predictive factors OTHER

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).

With live birth group; Without live birth group

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead

Study Sites (1)

CHR Metz-Thionville/Hopital de Mercy

Metz, 57085, France

Location

MeSH Terms

Conditions

Ovarian Hyperstimulation Syndrome

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Ariane GOUTALAND, MD

  CHR Metz Thionville Hopital de Mercy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 20, 2022
• Study Start: November 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: October 20, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)