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

Toulouse University Hospital

Status: Enrolling

Conditions: IVF

Treatments: Other: Questionnaire

Study type: Interventional

Funder types: Other

Identifiers

NCT05109676

RC31/21/0490

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Patients having embryo transfert

Experimental group

Description:

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.

Treatment:

Other: Questionnaire