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| Sponsor: | University of Connecticut |
|---|---|
| Collaborator: |
Organon |
| Information provided by: | University of Connecticut Health Center |
| ClinicalTrials.gov Identifier: | NCT00349258 |
Purpose
To compare the incidence of ovarian hyperstimulation syndrome (OHSS) and implantation rate between high responder patients using Gonadotropin releasing GnRH) agonist or human chorionic gonadotropin (hCG) to trigger final oocyte maturation.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Hyperstimulation Syndrome |
Drug: Leuprolide acetate |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Prospective Randomized Study Comparing the Use of hCG or GnRH Agonist to Trigger Final Oocyte Maturation in High Responders Undergoing in-Vitro Fertilization Treatment |
| Estimated Enrollment: | 66 |
| Study Start Date: | August 2004 |
| Estimated Study Completion Date: | May 2006 |
OHSS is an iatrogenic complication of controlled ovarian hyperstimulation, which in its severe form, may result in significant morbidity. Although, there have been significant advances in in-vitro fertilization (IVF) protocols over the years, the incidence of OHSS have remained stable and there is currently no effective way of preventing this disorder.
hCG is commonly used as a substitute for the endogenous LH surge to induce final oocyte maturation in IVF. Unfortunately, hCG results in a prolonged luteotropic effect because of its long half-life which may result in a potential risk of OHSS in high-risk patients. In contrast, induction of endogenous LH surge with a GnRH agonist may result in a reduced risk of OHSS. This is due both to the shorter half-life of the endogenous LH surge and the subsequent pituitary suppression leading to early luteolysis. However, previous studies have suggested that this approach may impair implantation rates.
There are no randomized studies assessing the effect of GnRH agonist to induce oocyte maturation on the occurrence of OHSS and implantation rates in high-risk patients. The aims of this study are to compare the incidence of OHSS and implantation rates among high-risk patients who used either GnRH agonist or hCG to trigger oocyte maturation after prevention of premature LH surge with either a GnRH antagonist protocol or the dual pituitary suppression protocol, respectively.
High risk patients include women with polycystic ovarian syndrome (PCOS) or PCO morphology (PCOM) on ultrasound without the clinical or biochemical evidence of the syndrome, and patients with previous high response to gonadotropins.
Eligibility| Ages Eligible for Study: | 20 Years to 39 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Connecticut | |
| Center for Advanced Reproductive Services, UCHC | |
| Farmington, Connecticut, United States, 06032 | |
| Principal Investigator: | Claudio Benadiva, MD | University of Connecticut Health Center |
| Principal Investigator: | Lawrence Engmann, MD | University of Connecticut Health Center |
More Information
| ClinicalTrials.gov Identifier: | NCT00349258 History of Changes |
| Other Study ID Numbers: | 04-277 |
| Study First Received: | July 5, 2006 |
| Last Updated: | July 5, 2006 |
| Health Authority: | United States: Institutional Review Board |
|
OHSS PCOS Previous high response |
GnRH antagonist GnRH agonist IVF |
|
Ovarian Hyperstimulation Syndrome Ovarian Diseases Adnexal Diseases Genital Diseases, Female Gonadal Disorders Endocrine System Diseases Deslorelin Leuprolide Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Fertility Agents, Female Fertility Agents Reproductive Control Agents Physiological Effects of Drugs |