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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05588635
Other study ID # 2022-05Obs-CHRMT
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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)
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