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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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 |
- 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 |
Inclusion Criteria:
- patients with PCOS
Contacts and Locations| China, Hubei | |
| Reproductive Medcine Research Center | |
| Shiyan, Hubei, China, 442000 | |
| 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 June 17, 2013