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Follicular Synchronization in PCOS Patients Undergoing ICSI

NCT04069117 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-04-06

No results posted yet for this study

Summary

The use of GnRH antagonist protocol nowadays is the slandered protocol of controlled ovarian stimulation in patients with poly cystic ovarian syndrome (PCOS) because it decreases the incidence of OHSS(1, 2). However, this protocol may lead to asynchronous growth of follicles with an early dominant follicle specially in PCOS patients(3). In most of cases this phenomenon will affect the IVF outcomes(2, 4) Aromatase inhibitors (AIs) nowadays is recommended to be used for ovulation induction in patients with PCOS (5, 6).It has fewer side effects, and a shorter half-life than clomiphene citrate(CC), and no effect ON the endometrial receptivity. It is used in treating patients with chronic anovulation, unexplained infertility and poor ovarian reserve(7). It acts through decreasing estrogen levels and allows follicle stimulating hormone (FSH) release from the hypothalamus (8, 9). It could be used alone or with combination with human menopausal gonadotropin (HMG) specially in patients with CC resistant(10-13). It also improves the ovarian response to FSH when they are used in combination and it decreases the risk of OHSS (14).

This study aims to evaluate the effect of uses of letrozole in combination with HMG during ovarian stimulation in patients having PCOS undergoing IVF/ICSI on the follicular growth pattern, synchronized growth of follicles, maturity of oocyte and the quality of embryos.

Conditions

  • Polycystic Ovarian Syndrome

Interventions

DRUG

letrozole 2.5mg (Femara; Novartis Pharma Services, Basel, Switzerland)

letrozole /antagonist protocol

Sponsors & Collaborators

  • Mansoura University Hospital

    lead OTHER

Principal Investigators

  • Mohamed E Taman, MD · Faculty of Medicine - Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2022-02-20
Completion
2022-02-20
FDA Drug
Yes

Countries

  • Egypt

Study Locations

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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 NCT04069117 on ClinicalTrials.gov