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

May 5, 2009
May 5, 2009
January 2008
December 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Letrozole Combined With Gonadotropins (Gn) for Ovarian Stimulation Undergoing in Vitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) in Patients With Polycystic Ovary Syndrome (PCOS)
Letrozole Combined With Gn for Ovarian Hyperstimulation Undergoing IVF/ICSI in Patients With PCOS

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Polycystic Ovarian Syndrome
  • Drug: letrozole + gonadotropins
    patients in letrozole protocol for ovarian stimulation with letrozole combined with gonadotropins
  • Drug: GnRHa + gonadotropins
    patients in long GnRHa protocol for ovarian stimulation with GnRHa and gonadotropins
  • Experimental: letrozole protocol
    patients in letrozole protocol for ovarian stimulation with letrozole combined with gonadotropins
    Intervention: Drug: letrozole + gonadotropins
  • Experimental: long GnRHa protocol
    patients in long GnRHa protocol for ovarian stimulation with Gnrha and gonadotropins
    Intervention: Drug: GnRHa + gonadotropins
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
90
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients with PCOS
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00894608
a00949200
Yes
reproductive medicine research center, renmin hospital
Yunyang Medical College
Not Provided
Study Director: zhang changjun, doctor renmin hospital,yunyang medical college
Yunyang Medical College
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP