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

Phase 4

Active, not recruiting

• Conditions: Subfertility

• Registration Number: 2024-511890-30-03
• Lead Sponsor: UZ Leuven

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Posted: 2025-01-22
• Last Update Posted: 2025-01-22

Recruitment & Eligibility

• Status: Ongoing, recruitment ended
• Sex: Female
• Target Recruitment: 554

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…)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate with fetal heart beat		Clinical pregnancy rate with fetal heart beat

Secondary Outcome Measures

Name	Time	Method
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		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)		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)

Trial Locations

Locations (5)

Ziekenhuis Aan De Stroom; 🇧🇪 Antwerp, Belgium

UZ Leuven; 🇧🇪 Leuven, Belgium

Jessa Ziekenhuis; 🇧🇪 Hasselt, Belgium

Clinique Saint-Jean Kliniek Sint-Jan; 🇧🇪 Brussels, Belgium

Imelda; 🇧🇪 Bonheiden, Belgium

Ziekenhuis Aan De Stroom

🇧🇪Antwerp, Belgium

Peter De loecker

Site contact

034433549

peter.deloecker@zas.be