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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05109676
Other study ID # RC31/21/0490
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 7, 2021
Est. completion date June 2023

Study information

Verified date November 2022
Source University Hospital, Toulouse
Contact Nicolas Gatimel, MD
Phone 5 67 77 10 08
Email gatimel.n@chu-toulouse.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

During an In Vitro Fertilization (IVF) attempt, several embryos are obtained but not all of them can be transferred to the uterus in the same cycle due to the risk of multiple pregnancies. Thus, it is very common for these couples to benefit from cryopreservation. Patients scheduled for frozen embryo transfer (TEC) receive estrogen and progesterone replacement therapy to prepare the endometrium for implantation. Data from the literature recently showed that low progesterone on the day of embryo transfer was responsible for a significantly higher rate of implantation failure and miscarriage.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date June 2023
Est. primary completion date June 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patient undergoing a frozen embryo transfer in an artificial cycle at the AMP center of the Toulouse University Hospital. - Affiliation to a social security scheme or equivalent - Patient fulfilling the conditions for access to the AMP according to French bioethics law - Patient having given her consent (oral or written) after clear and fair information Exclusion Criteria: - Patient who received intramuscular administration of progesterone during the endometrial preparation phase. - Patient with comprehension difficulties. - Protected adult patient (safeguard of justice, guardianship or curatorship)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire
A questionnaire will be offered to patients and identify the schedules of administration of progesterone, the day and time of blood samples taken as part of the care, the potential adverse events associated with this administration.

Locations

Country Name City State
France CHU Toulouse Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Average plasma progesterone concentration. Dosage of apparent clearance (CL/F) Day of embryo transfer.
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