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

IVF Clinical Trial

— PEKAPROGE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05109676
• Other study ID #: RC31/21/0490
• Status: Recruiting
• Phase: N/A
• Start date: December 7, 2021
• Est. completion date: June 2023

Study information

• Verified date: November 2022
• Source: University Hospital, Toulouse
• Contact: Nicolas Gatimel, MD
• Phone: 5 67 77 10 08
• Email: gatimel.n[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Infertility
• IVF

Intervention

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.

Locations

Country	Name	City	State
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average plasma progesterone concentration.	Dosage of apparent clearance (CL/F)	Day of embryo transfer.