Monitoring of Progesterone Administered in Infertile Patients During a Cycle of Frozen Embryo Transfer.

NCT05109676 | Completed

• 1 other identifier: RC31/21/0490
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

IVF

Outcome Measures

Primary Outcomes (1)

• Average plasma progesterone concentration.

  Dosage of apparent clearance (CL/F)

  Day of embryo transfer.

Study Arms (1)

Patients having embryo transfert

EXPERIMENTAL

Patients benefit from the usual treatment for frozen embryo transfer with a preparatory cycle of the artificial endometrium: 150 µg of percutaneous estradiol for approximately 11 days and 200 mg of progesterone morning and evening to be taken vaginally for 2 days in case of embryo transfer at day 2 stage, 3 days in case of embryo transfer at day 3 stage, 5 days in case of day 5 embryo transfer or 6 days in case of day 6 embryo transfer.

Other: Questionnaire

Interventions

Questionnaire OTHER

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.

Patients having embryo transfert

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU Toulouse

Toulouse, France

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Nicolas Gatimel, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 5, 2021
• Study Start: December 7, 2021
• Primary Completion: June 3, 2022
• Study Completion: June 3, 2022
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)