Clinical trial

Dydrogesterone-Primed Ovarian Stimulation Protocol Versus Gonadotropin Releasing Hormone Antagonist Protocol in Patients With Polycystic Ovary Syndrome Undergoing Intra-Cytoplasmic Sperm Injection

Name

9736-20-9-2022

Description

GnRH antagonist protocol is currently a good strategy for controlled ovarian stimulation in women with PCOS undergoing IVF/ICSI cycles. Finding a protocol that can be a better alternative will help in improving the success rate of IVF/ICSI cycles

Trial arms

Trial start

2023-02-20

Estimated PCD

2024-04-20

Trial end

2025-03-20

Status

Recruiting

Treatment

progestin primed ovarian stimulation protocol

Arms:

Group (A), group (B)

dydrogesterone (Duphaston, Abbott)

20 mg oral dose of dydrogesterone (Duphaston, Abbott)

Arms:

Group (A)

Cetrotide

0.25 mg of Cetrotide (gonadotropin releasing hormone (GnRH) antagonist)

Arms:

group (B)

Other names:

cetrorelix

Size

Primary endpoint

Efficacy (Number of MII oocytes retrieved)

3 months

Efficacy (Maturation index)

3 months

Eligibility criteria

Inclusion Criteria: 1. All patients should be candidates for ICSI. 2. Age between 20-40 years. 3. Body mass index 18-35 kg/m2. 4. Diagnosis of PCOS according to modified Rotterdam's criteria Exclusion Criteria: * 1) Any patient with contraindication to IVF treatment or pregnancy 2) Women with history of intra-uterine abnormality. 3) Severe endometriosis (grade 3 or 4) 4) Clinically significant systemic disease or other endocrinopathy.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 79, 'type': 'ESTIMATED'}}

Updated at

2023-03-02

1 organization

2 products

2 indications

Organization

Product

Indication

Indication

Product