What is the best cycle preparation for transferring a thawed embryo: a natural cycle or a cycle with hormonal medication?
Phase 1
- Conditions
- Patients with subfertility having frozen embryos after in vitro fertilization (IVF) or intracytoplasmatic sperm injection (ICSI)Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
- Registration Number
- EUCTR2018-001014-15-BE
- Lead Sponsor
- university hospital leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- 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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 554
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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
- Secondary Outcome Measures
Name Time Method