Clinical trial

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

Name

HRT_NC-FET

Description

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.

Trial arms

Trial start

2019-05-25

Estimated PCD

2025-09-01

Trial end

2025-12-01

Status

Recruiting

Phase

Early phase I

Treatment

Estradiol Valerate

Estradiol valerate will be started in the beginning of the menstrual cycle in order to induce proliferation of the endometrium.

Arms:

Hormone replacement therapy cycle

Other names:

Progynova

Micronized progesterone

If the endometrium is considered adequately proliferated, micronized progesterone is administered and frozen-thawed blastocyst transfer will take place on the 6th day of supplementation.

Arms:

Hormone replacement therapy cycle

Other names:

Utrogestan

Size

522

Primary endpoint

Miscarriage rate before 8 weeks of gestation

8 weeks

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized to either natural cycle frozen-thawed embryo transfer (group A), or hormonal replacement therapy cycle frozen-thawed embryo transfer (group B).', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 522, 'type': 'ESTIMATED'}}

Updated at

2024-04-16

1 organization

2 products

6 indications

Organization

CRG UZ Brussel

Product

Estradiol Valerate

Indication

Miscarriage

Indication