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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05109676
Acronym
PEKAPROGE
Enrollment
300
Registered
2021-11-05
Start date
2021-12-07
Completion date
2022-06-03
Last updated
2026-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IVF

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.

Interventions

OTHERQuestionnaire

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.

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Average plasma progesterone concentration.Day of embryo transfer.Dosage of apparent clearance (CL/F)

Countries

France

Contacts

PRINCIPAL_INVESTIGATORNicolas Gatimel, MD

University Hospital, Toulouse

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 8, 2026