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

Study Overview
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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.

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.

Official Title
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Letrozole Combined With Gn for Ovarian Hyperstimulation Undergoing IVF/ICSI in Patients With PCOS

Conditions
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Polycystic Ovarian Syndrome

Intervention / Treatment
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* Drug: letrozole + gonadotropins
* Drug: GnRHa + gonadotropins


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with PCOS
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: letrozole protocol<br>patients in letrozole protocol for ovarian stimulation with letrozole combined with gonadotropins | Drug: letrozole + gonadotropins<br>* patients in letrozole protocol for ovarian stimulation with letrozole combined with gonadotropins<br>|
| Experimental: long GnRHa protocol<br>patients in long GnRHa protocol for ovarian stimulation with Gnrha and gonadotropins | Drug: GnRHa + gonadotropins<br>* patients in long GnRHa protocol for ovarian stimulation with GnRHa and gonadotropins<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cycle cancellation rate, number of oocytes retrieved, fertilization rate, embryo quality, clinical pregnancy, implantation rates and OHSS rate |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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letrozole, ovarian stimulation, PCOS, IVF-ET