- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00349258
The Use of GnRH Agonist Trigger in the Prevention of OHSS
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Connecticut
-
Farmington, Connecticut, United States, 06032
- Center for Advanced Reproductive Services, UCHC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age 20-39
- normal early follicular phase serum FSH (≤10.0 IU/l)
- patients with either PCOS or PCOM undergoing their first cycle of IVF or patients with high response in a previous IVF cycle.
Exclusion Criteria:
- Hypogonadotropic hypogonadism
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
OHSS occurrence assessed one week after oocyte retrieval
|
Implantation rate assessed at seven weeks gestation
|
Secondary Outcome Measures
Outcome Measure |
---|
Clinical Pregnancy rate assessed at time of ultrasound
|
Mature oocytes assessed at time of retrieval
|
Ovarian volume assessed one week after oocyte retrieval
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lawrence Engmann, MD, UConn Health
- Principal Investigator: Claudio Benadiva, MD, UConn Health
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 04-277
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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