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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00894608
Recruitment Status : Unknown
Verified May 2009 by Yunyang Medical College.
Recruitment status was:  Enrolling by invitation
First Posted : May 7, 2009
Last Update Posted : May 7, 2009
Information provided by:
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.

Condition or disease Intervention/treatment
Polycystic Ovarian Syndrome Drug: letrozole + gonadotropins Drug: GnRHa + gonadotropins

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Letrozole Combined With Gn for Ovarian Hyperstimulation Undergoing IVF/ICSI in Patients With PCOS
Study Start Date : January 2008
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Letrozole
U.S. FDA Resources

Arm Intervention/treatment
Experimental: letrozole protocol
patients in letrozole protocol for ovarian stimulation with letrozole combined with gonadotropins
Drug: letrozole + gonadotropins
patients in letrozole protocol for ovarian stimulation with letrozole combined with gonadotropins
Experimental: long GnRHa protocol
patients in long GnRHa protocol for ovarian stimulation with Gnrha and gonadotropins
Drug: GnRHa + gonadotropins
patients in long GnRHa protocol for ovarian stimulation with GnRHa and gonadotropins

Primary Outcome Measures :
  1. Cycle cancellation rate, number of oocytes retrieved, fertilization rate, embryo quality, clinical pregnancy, implantation rates and OHSS rate [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • patients with PCOS

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00894608

China, Hubei
Reproductive Medcine Research Center
Shiyan, Hubei, China, 442000
Sponsors and Collaborators
Yunyang Medical College
Study Director: zhang changjun, doctor renmin hospital,yunyang medical college

Responsible Party: reproductive medicine research center, renmin hospital Identifier: NCT00894608     History of Changes
Other Study ID Numbers: a00949200
First Posted: May 7, 2009    Key Record Dates
Last Update Posted: May 7, 2009
Last Verified: May 2009

Keywords provided by Yunyang Medical College:
ovarian stimulation

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs