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

NCT ID: NCT00894608

Last Updated: 2009-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Polycystic Ovarian Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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letrozole protocol

patients in letrozole protocol for ovarian stimulation with letrozole combined with gonadotropins

Group Type EXPERIMENTAL

letrozole + gonadotropins

Intervention Type DRUG

patients in letrozole protocol for ovarian stimulation with letrozole combined with gonadotropins

long GnRHa protocol

patients in long GnRHa protocol for ovarian stimulation with Gnrha and gonadotropins

Group Type EXPERIMENTAL

GnRHa + gonadotropins

Intervention Type DRUG

patients in long GnRHa protocol for ovarian stimulation with GnRHa and gonadotropins

Interventions

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letrozole + gonadotropins

patients in letrozole protocol for ovarian stimulation with letrozole combined with gonadotropins

Intervention Type DRUG

GnRHa + gonadotropins

patients in long GnRHa protocol for ovarian stimulation with GnRHa and gonadotropins

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients with PCOS
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Yunyang Medical College

OTHER

Sponsor Role lead

Responsible Party

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renmin hospital

Principal Investigators

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zhang changjun, doctor

Role: STUDY_DIRECTOR

renmin hospital,yunyang medical college

Locations

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Reproductive Medcine Research Center

Shiyan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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a00949200

Identifier Type: -

Identifier Source: org_study_id

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