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

Study Overview
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Brief Summary
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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.

Official Title
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Monitoring of Progesterone Administered in Infertile Patients During a Cycle of Frozen Embryo Transfer: a Population Pharmacokinetic Study.

Conditions
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IVF

Intervention / Treatment
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* Other: Questionnaire


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients having embryo transfert<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average plasma progesterone concentration. | Dosage of apparent clearance (CL/F) | Day of embryo transfer. |