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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| letrozole protocol | Experimental | patients in letrozole protocol for ovarian stimulation with letrozole combined with gonadotropins |
|
| long GnRHa protocol | Experimental | patients in long GnRHa protocol for ovarian stimulation with Gnrha and gonadotropins |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| letrozole + gonadotropins | Drug | patients in letrozole protocol for ovarian stimulation with letrozole combined with gonadotropins |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cycle cancellation rate, number of oocytes retrieved, fertilization rate, embryo quality, clinical pregnancy, implantation rates and OHSS rate | 2 years |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| zhang changjun, doctor | renmin hospital,yunyang medical college | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reproductive Medcine Research Center | Shiyan | Hubei | 442000 | China |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 24, 2009 | |
| Reset | Sep 29, 2009 | |
| Release | Oct 1, 2009 |
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| GnRHa + gonadotropins | Drug | patients in long GnRHa protocol for ovarian stimulation with GnRHa and gonadotropins |
|
| Reset | Nov 5, 2009 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 24, 2009 | Sep 29, 2009 | |||
| Oct 1, 2009 | Nov 5, 2009 |
| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077289 | Letrozole |
| D006062 | Gonadotropins |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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