MedTrace Logo

Effect of GnRH Agonist vs GnRH Antagonist on IVF/ICSI Outcomes in Polycystic Ovary Syndrome Patients.

NCT04727671 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-10-24

No results posted yet for this study

Summary

This prospective, non-randomised, open-label, clinical trial is conducting on polycystic ovary syndrome (PCOS) subjects to compare the effects of two pituitary suppression regimens; GnRH Agonist-Long Protocol and GnRH Antagonist-Flexible Protocol on clinical and embryological IVF/ICSI outcomes, and on the follicular fluid levels of Placental Growth Factor (PlGF); which is known for his pivotal role in the regulation of ovulation, embryo development, and implantation

Conditions

  • In Vitro Fertilization
  • Intracytoplasmic Sperm Injection
  • Infertility
  • Polycystic Ovary Syndrome

Interventions

DRUG

Triptorelin acetate

0.05-0.1 mg subcutaneously (SC) once daily from the mid-luteal phase (day 21) of the cycle until the day of ovulation triggering.

DRUG

Cetrorelix

0.25 mg subcutaneously (SC) once daily starting from the day detecting a leading follicle diameter ≥ 14 mm until the day of ovulation triggering.

DRUG

recombinant-FSH or recombinant-FSH + human Menopausal Gonadotropin

Dosage adjustment according to the ovarian response.

DRUG

Human Chorionic Gonadotropin (hCG)

Ovulation will be triggered by the administration of 10,000 IU of Human Chorionic Gonadotropin (hCG) when at least three follicles become more than 16-17 mm.

Sponsors & Collaborators

  • Damascus University

    lead OTHER

Principal Investigators

  • Sally Kadoura, B Pharm, MD · Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Damascus University, Damascus, Syria

  • Abdul Hakim Nattouf, MD, PhD · Professor at Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Damascus University, Damascus, Syria

  • Marwan Alhalabi, MD, PhD · Professor at Department of Embryology and Reproductive Medicine, Faculty of Medicine, Damascus University, Damascus, Syria.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-22
Primary Completion
2021-08-15
Completion
2021-12-30

Countries

  • Syria

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04727671 on ClinicalTrials.gov