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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Yunyang Medical College
ClinicalTrials.gov Identifier:
NCT00894608
First received: May 5, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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 Intervention
Polycystic Ovarian Syndrome
Drug: letrozole + gonadotropins
Drug: GnRHa + gonadotropins

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Letrozole Combined With Gn for Ovarian Hyperstimulation Undergoing IVF/ICSI in Patients With PCOS

Resource links provided by NLM:


Further study details as provided by Yunyang Medical College:

Primary Outcome Measures:
  • Cycle cancellation rate, number of oocytes retrieved, fertilization rate, embryo quality, clinical pregnancy, implantation rates and OHSS rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: January 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with PCOS
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00894608

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

No publications provided

Responsible Party: reproductive medicine research center, renmin hospital
ClinicalTrials.gov Identifier: NCT00894608     History of Changes
Other Study ID Numbers: a00949200
Study First Received: May 5, 2009
Last Updated: May 5, 2009
Health Authority: China: Ministry of Health

Keywords provided by Yunyang Medical College:
letrozole
ovarian stimulation
PCOS
IVF-ET

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Letrozole
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014