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

Primary Purpose

IVF

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Questionnaire

About this trial

This is an interventional basic science trial for IVF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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)

Sites / Locations

CHU ToulouseRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients having embryo transfert

Arm 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.

Outcomes

Primary Outcome Measures

Average plasma progesterone concentration.

Dosage of apparent clearance (CL/F)

Secondary Outcome Measures

Full Information

NCT ID

NCT05109676

First Posted

October 27, 2021

Last Updated

November 14, 2022

Sponsor

University Hospital, Toulouse

1. Study Identification

Unique Protocol Identification Number

NCT05109676

Brief Title

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

Acronym

PEKAPROGE

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

December 7, 2021 (Actual)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

IVF

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients having embryo transfert

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Questionnaire

Intervention Description

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.

Primary Outcome Measure Information:

Title

Average plasma progesterone concentration.

Description

Dosage of apparent clearance (CL/F)

Time Frame

Day of embryo transfer.

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nicolas Gatimel, MD

Phone

5 67 77 10 08

Ext

+33

gatimel.n@chu-toulouse.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nicolas Gatimel, MD

Organizational Affiliation

CHU Toulouse

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Toulouse

City

Toulouse

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicolas Gatimel

Phone

0567771008

gatimel.n@chu-toulouse.fr

First Name & Middle Initial & Last Name & Degree

Nicolas Gatimel

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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