Infertility Clinical Trial
Official title:
Impact of Serum Progesterone Levels on the Day of Fresh and Frozen Embryo Transfer on the Ongoing Pregnancy Rates
NCT number | NCT04839627 |
Other study ID # | PROGESTE |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 16, 2021 |
Est. completion date | June 1, 2023 |
Verified date | July 2023 |
Source | Hospital St. Joseph, Marseille, France |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Serum progesterone levels prepare the endometrium for implantation and play an important role during embryo transfer (ET). In clinical practice, luteal phase support progesterone supplementation is systematically offered to all women undergoing medically assisted procreation (AMP), independently of ET conditions (fresh and frozen). The investigators propose to perform a prospective cross-sectional single-center cohort study to measure progesterone levels on the day of the ET on all AMP cycles and to compare these levels between active pregnancies and ET unsuccessful cycles. They will determine progesterone threshold levels corresponding to successful attempts in all ET strategies (fresh and frozen) as well as clinical and biological risk factors leading to luteal phase deficiency during ET. They could therefore individualize progesterone supplementation according to patient's needs.
Status | Completed |
Enrollment | 250 |
Est. completion date | June 1, 2023 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years - planned embryo transfer - signed informed consent Exclusion Criteria: - patients falsely included, major inclusion criteria not respected - lack of social insurance - refusal to participate in the research |
Country | Name | City | State |
---|---|---|---|
France | Hopital Saint Joseph Marseille | Marseille |
Lead Sponsor | Collaborator |
---|---|
Hospital St. Joseph, Marseille, France |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum progesterone levels on the day of embryo transfer | µg/L | During the procedure | |
Secondary | pregnancy rate | Post-embryo transfer ßHCG levels (UI/l). | 1 month after procedure |
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