Ovarian Hyperstimulation Syndrome Clinical Trial
— PROGEVOLOfficial title:
Association Between Live Birth Rate and Serum Progesterone on Frozen-thawed Embryo Transfer Day: Retrospective Study
Verified date | October 2022 |
Source | Centre Hospitalier Régional Metz-Thionville |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | CHR Metz-Thionville/Hopital de Mercy | Metz |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Régional Metz-Thionville |
France,
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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