CClinicalTrials.gg
CompletedNCT05109676PEKAPROGEUpdated May 7, 2026

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

An interventional study of Questionnaire in IVF, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-07.

Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • IVF
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In context

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts 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

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)
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (actual)

Study arms

  • 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

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.

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What researchers measure

Primary outcomes

  1. Average plasma progesterone concentration.

    Dosage of apparent clearance (CL/F)

    Time frame: Day of embryo transfer.

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Study locations

1 site
  • CHU Toulouse
    Toulouse, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05109676
Lead sponsor
University Hospital, Toulouse
Responsible party
Sponsor
First posted
Nov 5, 2021
Start date
Dec 7, 2021
Primary completion
Jun 3, 2022
Completion
Jun 3, 2022
Last update
May 7, 2026

Study contacts

Nicolas Gatimel, MD
principal investigator · University Hospital, Toulouse

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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