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

Ovarian Hyperstimulation Syndrome Clinical Trial

— PROGEVOL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05588635
• Other study ID #: 2022-05Obs-CHRMT
• Status: Completed
• Start date: November 1, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: October 2022
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: March 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

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

Related Conditions & MeSH terms

• Ovarian Hyperstimulation Syndrome

Intervention

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).

Locations

Country	Name	City	State
France	CHR Metz-Thionville/Hopital de Mercy	Metz

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pregnancy status	Pregnancy status (yes/no)	12 days after embryo transfer (Day 12)
Secondary	Serum progesterone	Measurement of serum progesterone (ng/ml)	12 days after embryo transfer (Day 12)