Gonadotropin-releasing Hormone Antagonist on Triggering Day: A Randomized Controlled Study
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
cetrorelix acetate
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- Both ovaries present with no morphological abnormalities
- Normal ovulatory cycle with cycle lengths of between 25 and 35 days
- Basal serum FSH (day 3) level of < 15 mIU/mL
- Body mass index (BMI) ranging between 18 and 27 kg/m2
Exclusion Criteria:
- History of a poor ovarian response
- Evidence of endocrine abnormalities, such as, hyperprolactinemia, thyroid dysfunction, or polycystic ovary syndrome
- Hydrosalpinx
- Severe endometriosis (stage III-IV)
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
A
B
Arm Description
Stimulated as conventional protocol
GnRH antagonist stopped one day earlier than conventional protocol
Outcomes
Primary Outcome Measures
Maturity of oocytes, fertilization rate, embryo quality
Secondary Outcome Measures
Full Information
NCT ID
NCT00571870
First Posted
December 10, 2007
Last Updated
August 20, 2009
Sponsor
Seoul National University Bundang Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00571870
Brief Title
Gonadotropin-releasing Hormone Antagonist on Triggering Day: A Randomized Controlled Study
Official Title
Study on the Effect of GnRH Antagonist on hCG Day on Outcomes of Controlled Ovarian Hyperstimulation With GnRH Antagonist Flexible Multiple-dose Protocols
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Seoul National University Bundang Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Gonadotropin-releasing hormone (GnRH) antagonists have been widely used for the prevention of premature luteinizing hormone (LH) surges during controlled ovarian hyperstimulation (COH) for in vitro fertilization and embryo transfer (IVF-ET) since the late 1990's.
Many years have passed since GnRH antagonists were introduced to prevent premature LH surges during stimulated cycles. However, there is still no consensus on the optimal GnRH antagonist protocol. Attempts at modifying GnRH antagonist protocols have been made to improve COH outcomes. However, a meta-analysis of 27 randomized controlled trials, including recent reports, showed significantly lower clinical ongoing pregnancy rates in the antagonist group. Thus, additional efforts are needed to identify the optimal stimulation protocols to achieve better follicular and embryonic development and to improve the pregnancy rates in COH using GnRH antagonist.
Given the assumption of a detrimental effect of GnRH antagonist on the pregnancy rate, with current protocols, we hypothesized that a shorter duration of GnRH antagonist administration might improve outcome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
Stimulated as conventional protocol
Arm Title
B
Arm Type
Experimental
Arm Description
GnRH antagonist stopped one day earlier than conventional protocol
Intervention Type
Drug
Intervention Name(s)
cetrorelix acetate
Intervention Description
The GnRH antagonist, cetrorelix acetate (Cetrotide; Serono) 0.25 mg was added daily, starting when the leading follicle reached 14 mm in diameter during ovarian stimulation for IVF. When the leading follicle reached a mean diameter of 18 mm or two follicles or more reached a diameter of 17 mm, 250 μg of recombinant hCG (Ovidrel; Serono) SQ was injected. In Group A, the GnRH antagonist continued to be used until the day of hCG administration. In Group B, the GnRH antagonist was not administrated on the hCG day
Primary Outcome Measure Information:
Title
Maturity of oocytes, fertilization rate, embryo quality
Time Frame
3 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Both ovaries present with no morphological abnormalities
Normal ovulatory cycle with cycle lengths of between 25 and 35 days
Basal serum FSH (day 3) level of < 15 mIU/mL
Body mass index (BMI) ranging between 18 and 27 kg/m2
Exclusion Criteria:
History of a poor ovarian response
Evidence of endocrine abnormalities, such as, hyperprolactinemia, thyroid dysfunction, or polycystic ovary syndrome
Hydrosalpinx
Severe endometriosis (stage III-IV)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang Suk Suh, M.D., Ph.D.
Organizational Affiliation
Dept. of Obstetrics and Gynecology, Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Gonadotropin-releasing Hormone Antagonist on Triggering Day: A Randomized Controlled Study
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