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Clinical Trials/2024-511890-30-03
2024-511890-30-03
Active, not recruiting
Phase 4

Frozen-thawed embryo transfer in a natural versus artificial cycle: a randomized clinical trial.

UZ Leuven5 sites in 1 country554 target enrollmentJanuary 22, 2025
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DrugsProgynova 2 mg dragerade tabletterUtrogestan 200 mg capsule molli vaginali

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Not specified
Sponsor
UZ Leuven
Enrollment
554
Locations
5
Primary Endpoint
Clinical pregnancy rate with fetal heart beat
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Finding the optimal endometrial preparation protocol for transfer of a frozen-thawed embryo

Registry
euclinicaltrials.eu
Start Date
January 22, 2025
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
UZ Leuven
Responsible Party
Principal Investigator
Principal Investigator

Joke De Roover

Scientific

UZ Leuven

Eligibility Criteria

Inclusion Criteria

  • •Women undergoing FET after a first, second or third fresh IVF/ICSI cycle
  • •Single embryo transfer (SET) or Double embryo transfer (DET)
  • •Female age between 18-45 year
  • •Women having a natural ovulatory cycle (24-35 days)
  • •Normal uterine cavity (fundal indentation at the cavity <10mm)
  • •Written informed consent

Exclusion Criteria

  • •Use of donor gametes
  • •BMI > or equal to 35 kg / m2
  • •Any contra-indication to estrogen or progesterone supplementation (e.g. history of thrombosis, prior or current hormone-sensitive malignancy…)

Outcomes

Primary Outcomes

Clinical pregnancy rate with fetal heart beat

Clinical pregnancy rate with fetal heart beat

Secondary Outcomes

  • Biochemical pregnancy rate, miscarriage rate, ectopic pregnancy rate, live birth rate, multiple pregnancy rate, adverse events, cycle cancellation rate, endometrial thickness, endometrial pattern, number of center visits to monitor FET cycle, cost analysis per cycle, patient satisfaction
  • Obstetrical outcomes in case of pregnancy: gestational age, birth weight, incidence of pregnancy- induced hypertension, pre-eclampsia, placenta previa, placenta accrete/increta/percreta, abruptio placentae, postpartum hemorrhage (early, late)

Study Sites (5)

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