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

Study Overview
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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.

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

Conditions
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Ovarian Hyperstimulation Syndrome, Frozen-thawed Embryo Transfers

Intervention / Treatment
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* Other: Identification of predictive factors


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| With live birth group<br>patients with live birth following frozen-thawed embryo transfer | Other: Identification of predictive factors<br>* 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).<br>|
| Without live birth group<br>patients without live birth following frozen-thawed embryo transfer | Other: Identification of predictive factors<br>* 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).<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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serum progesterone, frozen-thawed embryo transfer, live birth rate