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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

168 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2021-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Ovarian Hyperstimulation Syndrome Frozen-thawed Embryo Transfers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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With live birth group

patients with live birth following frozen-thawed embryo transfer

Identification of predictive factors

Intervention Type 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).

Without live birth group

patients without live birth following frozen-thawed embryo transfer

Identification of predictive factors

Intervention Type 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).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No