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

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

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.

Study Overview

• Status: Recruiting
• Conditions: IVF
• Intervention / Treatment: Other: Questionnaire

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas Gatimel, MD; Phone Number: +33 5 67 77 10 08; Email: gatimel.n@chu-toulouse.fr

Study Locations

• France
  • Toulouse, France
    • Recruiting
    • CHU Toulouse
    • Contact: Nicolas Gatimel; Phone Number: 0567771008; Email: gatimel.n@chu-toulouse.fr
    • Principal Investigator: Nicolas Gatimel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Nicolas Gatimel, MD, CHU Toulouse

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 7, 2021
• Primary Completion (ANTICIPATED): June 1, 2023
• Study Completion (ANTICIPATED): June 1, 2023

Study Registration Dates

• First Submitted: October 27, 2021
• First Submitted That Met QC Criteria: October 27, 2021
• First Posted (ACTUAL): November 5, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: RC31/21/0490

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No