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Gonadotropin-releasing Hormone Antagonist on Triggering Day: A Randomized Controlled Study

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT00571870
First received: December 10, 2007
Last updated: August 20, 2009
Last verified: August 2009
History of Changes
  Purpose

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.


Condition Intervention
Infertility
 Drug: cetrorelix acetate

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Maturity of oocytes, fertilization rate, embryo quality [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: November 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Stimulated as conventional protocol
 Drug: cetrorelix acetate
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
Experimental: B
GnRH antagonist stopped one day earlier than conventional protocol
 Drug: cetrorelix acetate
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00571870

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Chang Suk Suh, M.D., Ph.D. Dept. of Obstetrics and Gynecology, Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Chang Suk Suh, Dept. of Obstetrics and Gynecology, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT00571870     History of Changes
Other Study ID Numbers: B-0710-050-001
Study First Received: December 10, 2007
Last Updated: August 20, 2009
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Hormone Antagonists
 Cetrorelix
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013