Letrozole Combined With Gonadotropins (Gn) for Ovarian Stimulation Undergoing in Vitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) in Patients With Polycystic Ovary Syndrome (PCOS)

Not Applicable

• Conditions: Polycystic Ovarian Syndrome
• Interventions: Drug: letrozole + gonadotropins; Drug: GnRHa + gonadotropins

• Registration Number: NCT00894608
• Lead Sponsor: Yunyang Medical College

Brief Summary

The purpose of this study is to determine whether letrozole combined with gonadotropins are effective in the ovarian hyperstimulating for IVF/ICSI in patients with PCOS.

Detailed Description

Polycystic ovarian syndrome (PCOS) occurs in 4% to 7% of all women of reproductive age and 20% of women presenting with anovulatory infertility. A significant proportion of these women will ultimately need assisted reproductive techniques. Various protocols of ovarian stimulation such as step up protocol, coasting, GnRH antagonists et al have been proposed for optimizing IVF results in patients with PCOS. The results of these studies have shown it not to be satisfied. The preliminary studies have proven that Letrozole, a potent and highly specific nonsteroidal aromatase inhibitor, could successfully induce ovulation in women with polycystic ovary syndrome. In spite of only a little study research of letrozole in IVF/ICSI cycle, for poor ovarian responders, addition of letrozole improved ovarian response to FSH and reduced gonadotrophin dose required for COH without having a negative impact on pregnancy rates. These reports prompted us to hypothesize that adjunctive use of letrozole in COH protocol for patients with PCOS would minimize the gonadotrophin dose, and consequently the cost, and lower the risk of OHSS in a IVF/ICSI treatment cycle.

Study Timeline

• Study Start: 2008-01
• Status Verified: 2009-05
• Study First Submitted: 2009-05-05
• Study First Submitted QC: 2009-05-05
• Last Update Submitted: 2009-05-05
• Study First Posted: 2009-05-07
• Last Update Posted: 2009-05-07
• Primary Completion: 2009-12
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

• patients with PCOS

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
letrozole protocol	letrozole + gonadotropins	patients in letrozole protocol for ovarian stimulation with letrozole combined with gonadotropins
long GnRHa protocol	GnRHa + gonadotropins	patients in long GnRHa protocol for ovarian stimulation with Gnrha and gonadotropins

Primary Outcome Measures

Name	Time	Method
Cycle cancellation rate, number of oocytes retrieved, fertilization rate, embryo quality, clinical pregnancy, implantation rates and OHSS rate	2 years

Trial Locations

Locations (1)

Reproductive Medcine Research Center; 🇨🇳 Shiyan, Hubei, China