The Use of GnRH Agonist Trigger in the Prevention of OHSS
Primary Purpose
Ovarian Hyperstimulation Syndrome
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Leuprolide acetate
Sponsored by
About this trial
This is an interventional prevention trial for Ovarian Hyperstimulation Syndrome focused on measuring OHSS, PCOS, Previous high response, GnRH antagonist, GnRH agonist, IVF
Eligibility Criteria
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
Sites / Locations
- Center for Advanced Reproductive Services, UCHC
Outcomes
Primary Outcome Measures
OHSS occurrence assessed one week after oocyte retrieval
Implantation rate assessed at seven weeks gestation
Secondary Outcome Measures
Clinical Pregnancy rate assessed at time of ultrasound
Mature oocytes assessed at time of retrieval
Ovarian volume assessed one week after oocyte retrieval
Full Information
NCT ID
NCT00349258
First Posted
July 5, 2006
Last Updated
July 5, 2006
Sponsor
University of Connecticut
Collaborators
Organon
1. Study Identification
Unique Protocol Identification Number
NCT00349258
Brief Title
The Use of GnRH Agonist Trigger in the Prevention of OHSS
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2006
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Connecticut
Collaborators
Organon
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Hyperstimulation Syndrome
Keywords
OHSS, PCOS, Previous high response, GnRH antagonist, GnRH agonist, IVF
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Leuprolide acetate
Primary Outcome Measure Information:
Title
OHSS occurrence assessed one week after oocyte retrieval
Title
Implantation rate assessed at seven weeks gestation
Secondary Outcome Measure Information:
Title
Clinical Pregnancy rate assessed at time of ultrasound
Title
Mature oocytes assessed at time of retrieval
Title
Ovarian volume assessed one week after oocyte retrieval
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudio Benadiva, MD
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lawrence Engmann, MD
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Advanced Reproductive Services, UCHC
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21601197
Citation
Engmann L, Romak J, Nulsen J, Benadiva C, Peluso J. In vitro viability and secretory capacity of human luteinized granulosa cells after gonadotropin-releasing hormone agonist trigger of oocyte maturation. Fertil Steril. 2011 Jul;96(1):198-202. doi: 10.1016/j.fertnstert.2011.04.071. Epub 2011 May 20.
Results Reference
derived
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The Use of GnRH Agonist Trigger in the Prevention of OHSS
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