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

NCT ID: NCT05109676

Last Updated: 2022-11-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-07
• Study Completion Date: 2023-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Patients having embryo transfert

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.

Group Type: EXPERIMENTAL

Questionnaire

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nicolas Gatimel, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

CHU Toulouse

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Nicolas Gatimel, MD

Role: CONTACT

gatimel.n@chu-toulouse.fr

5 67 77 10 08 ext. +33

Facility Contacts

Nicolas Gatimel

Role: primary

gatimel.n@chu-toulouse.fr

0567771008

Other Identifiers

RC31/21/0490

Identifier Type: -

Identifier Source: org_study_id