TerminatedPhase 4

Natural Cycle Versus Hormone Replacement Therapy Cycle for a Frozen-thawed Embryo Transfer in PGT Patients

Stopped: safety

Belgium362 participantsStarted 2019-05-25

Plain-language summary

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.

Who can participate

Age range18 Years – 42 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Miscarriage rate before 8 weeks of gestation

Timeframe: 8 weeks

Trial details

NCT IDNCT03976544

SponsorCRG UZ Brussel

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-01

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