Is there a difference in early pregnancy loss between an endometrium prepared in a natural cycle or by medication prior to transfer of a frozen-thawed embryo?
Phase 1
- Conditions
- Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]Female infertility
- Registration Number
- EUCTR2018-003156-20-BE
- Lead Sponsor
- CRG UZ Brussel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 522
Inclusion Criteria
-Age between 18 and 42 years
-BMI under 35 kg/m2
-Regular menstrual cycle pattern (i.e. 24-35 days cycle)
-First, second and third ICSI-PGT cycle
-First frozen embryo transfer cycle following a fresh ICSI-PGT attempt
-PGT with trophectoderm biopsy on day 5 of embryonic development
-Signed informed consent
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 522
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
-Oligo-amenorrhea
-Age above 43 years
- BMI above 35
-Contraindications for the use of hormonal replacement therapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: The aim of the current study is to compare miscarriage rates (before 8 weeks) between true natural cycle (awaiting spontaneous LH surge) and hormone replacement therapy frozen-warmed embryo transfer cycles in pre-implantation genetic (PGT) testing patients, with biopsy on day 5 of embryonic development. The advantage of performing the study in PGT patients is the exclusion of aneuploidy as a cause of miscarriage.<br> ;<br> Secondary Objective: not applicable<br> ;Primary end point(s): miscarriage rate before 8 weeks of gestation;Timepoint(s) of evaluation of this end point: at the end of the study, if 522 patients are included
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): Miscarriage rate after 8 weeks of gestation<br> Clinical pregnancy rate<br> Ongoing pregnancy rate<br> ;Timepoint(s) of evaluation of this end point: at the end of the study, if 522 patients are included