Miscarriage Clinical Trial
Official title:
Natural Cycle Versus Hormone Replacement Therapy Cycle for a Frozen-thawed Embryo Transfer in PGT Patients: A Randomized Trial
Verified date | April 2024 |
Source | CRG UZ Brussel |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the current study is to compare miscarriage rates (before 8 weeks) between a true natural cycle (awaiting spontaneous LH surge) and a hormone replacement therapy cycle prior to blastocyst transfer in preimplantation genetic testing (PGT) 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.
Status | Recruiting |
Enrollment | 522 |
Est. completion date | December 1, 2025 |
Est. primary completion date | September 1, 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 42 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Oligo-amenorrhea - BMI above 35 - Contraindications for the use of hormonal replacement therapy |
Country | Name | City | State |
---|---|---|---|
Belgium | Centre for Reproductive Medicine UZ Brussel | Brussels |
Lead Sponsor | Collaborator |
---|---|
CRG UZ Brussel |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Miscarriage rate before 8 weeks of gestation | a spontaneous loss of a clinical pregnancy before 8 weeks of gestational age, in which the embryo(s) is/are nonviable and is/are (not) spontaneously absorbed or expelled from the uterus per initiated embryo transfer cycle and per positive hCG | 8 weeks | |
Secondary | Miscarriage rate after 8 weeks of gestation | a spontaneous loss of a clinical pregnancy after 8 weeks but before 22 completed weeks of gestational age, in which the embryo(s) or fetus(es) is/are nonviable and is/are not spontaneously absorbed or expelled from the uterus per initiated embryo transfer cycle and per positive hCG | 22 weeks | |
Secondary | Clinical pregnancy rate | a pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy per initiated embryo transfer cycles | 7 weeks | |
Secondary | Ongoing pregnancy rate | the number of pregnancies after 20 weeks of gestation per initiated embryo transfer cycle | 20 weeks |
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