Letrozole Combined With Gonadotropins (Gn) for Ovarian Stimulation Undergoing in Vitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) in Patients With Polycystic Ovary Syndrome (PCOS)
Primary Purpose
Polycystic Ovarian Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
letrozole + gonadotropins
GnRHa + gonadotropins
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovarian Syndrome focused on measuring letrozole, ovarian stimulation, PCOS, IVF-ET
Eligibility Criteria
Inclusion Criteria:
- patients with PCOS
Sites / Locations
- Reproductive Medcine Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
letrozole protocol
long GnRHa protocol
Arm Description
patients in letrozole protocol for ovarian stimulation with letrozole combined with gonadotropins
patients in long GnRHa protocol for ovarian stimulation with Gnrha and gonadotropins
Outcomes
Primary Outcome Measures
Cycle cancellation rate, number of oocytes retrieved, fertilization rate, embryo quality, clinical pregnancy, implantation rates and OHSS rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00894608
Brief Title
Letrozole Combined With Gonadotropins (Gn) for Ovarian Stimulation Undergoing in Vitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) in Patients With Polycystic Ovary Syndrome (PCOS)
Official Title
Letrozole Combined With Gn for Ovarian Hyperstimulation Undergoing IVF/ICSI in Patients With PCOS
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2009 (Anticipated)
Study Completion Date
December 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Yunyang Medical College
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovarian Syndrome
Keywords
letrozole, ovarian stimulation, PCOS, IVF-ET
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
letrozole protocol
Arm Type
Experimental
Arm Description
patients in letrozole protocol for ovarian stimulation with letrozole combined with gonadotropins
Arm Title
long GnRHa protocol
Arm Type
Experimental
Arm Description
patients in long GnRHa protocol for ovarian stimulation with Gnrha and gonadotropins
Intervention Type
Drug
Intervention Name(s)
letrozole + gonadotropins
Intervention Description
patients in letrozole protocol for ovarian stimulation with letrozole combined with gonadotropins
Intervention Type
Drug
Intervention Name(s)
GnRHa + gonadotropins
Intervention Description
patients in long GnRHa protocol for ovarian stimulation with GnRHa and gonadotropins
Primary Outcome Measure Information:
Title
Cycle cancellation rate, number of oocytes retrieved, fertilization rate, embryo quality, clinical pregnancy, implantation rates and OHSS rate
Time Frame
2 years
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with PCOS
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhang changjun, doctor
Organizational Affiliation
renmin hospital,yunyang medical college
Official's Role
Study Director
Facility Information:
Facility Name
Reproductive Medcine Research Center
City
Shiyan
State/Province
Hubei
ZIP/Postal Code
442000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Letrozole Combined With Gonadotropins (Gn) for Ovarian Stimulation Undergoing in Vitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) in Patients With Polycystic Ovary Syndrome (PCOS)
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