Clinical trial

Effectiveness of Progestin-Primed Ovarian Stimulation Versus GnRH Antagonist Protocol for Ovarian Stimulation in IVF: a Randomized Clinical Trial

Name

05/24/DD-BVMD

Description

This non-inferiority randomized controlled trial will be conducted at My Duc Hospital, Ho Chi Minh City, Vietnam. This study compares the effectiveness of Progestin-Primed Ovarian stimulation versus GnRH protocol for ovarian stimulation in IVF treatment. Participants will be randomly assigned in a 1:1 ratio to receive Progestins or GnRH antagonists.

Trial arms

Trial start

2024-04-24

Estimated PCD

2025-12-31

Trial end

2026-09-30

Status

Recruiting

Treatment

Dydrogesterone 10 mg

Dydrogesterone 10mg orally 2 times daily, starting on the day of gonadotropin injection to the oocyte maturation trigger night.

Arms:

Progestins Primed Ovarian stimulation group

Other names:

Duphaston

Cetrorelix 0.25 mg

Cetrorelix 0.25mg is injected subcutaneously once a day. It is given from day 5 or day 6 of stimulation by the oocyte maturation trigger day.

Arms:

GnRH antagonist group

Other names:

Cetrotide

Size

626

Primary endpoint

Ongoing pregnancy

At 10 weeks after embryo(s) placement

Eligibility criteria

Inclusion Criteria: * Woman aged 18-40 * BMI ≤ 25kg/m2 * AMH \> 1.2ng/mL or AFC \>5 * Having indication for IVF treatment * Agree to have frozen embryo(s) transfer * Not participating in any other clinical trials * Provision of written informed consent to participate Exclusion Criteria: * Undergoing IVF cycle with other protocols: Down-regulation, mild stimulation, Random start * Oocyte donation cycles * Undergoing vitrified oocyte accumulation * Oocyte cryopreservation * Cycle with PGT (Preimplatation genetic testing) * Women with PCOS * Women allergy to dydrogesterone, rFSH, GnRH antagonist

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 626, 'type': 'ESTIMATED'}}

Updated at

2024-04-26

1 organization

2 products

1 indication

Organization

Mỹ Đức Hospital

Product

Dydrogesterone

Indication

Progestins Primed Ovarian Stimulation

Product

Cetrorelix