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OpenTrials
Completed

NCT Number: NCT05109676

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

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.

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Key information

Conditions

IVF

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU Toulouse

Toulouse, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Questionnaire

Other

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 outcomes

  1. Average plasma progesterone concentration.

    Time frame: Day of embryo transfer.

    Dosage of apparent clearance (CL/F)

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: PEKAPROGE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 5, 2021
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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