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

NCT00571870 | Completed

• 1 other identifier: B-0710-050-001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Maturity of oocytes, fertilization rate, embryo quality

  3 days

Study Arms (2)

A

ACTIVE COMPARATOR

Stimulated as conventional protocol

Drug: cetrorelix acetate

B

EXPERIMENTAL

GnRH antagonist stopped one day earlier than conventional protocol

Drug: cetrorelix acetate

Interventions

cetrorelix acetate DRUG

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

A; B

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Infertility

Interventions

cetrorelix

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Chang Suk Suh, M.D., Ph.D.

  Dept. of Obstetrics and Gynecology, Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 10, 2007
• First Posted: December 12, 2007
• Study Start: November 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: August 21, 2009

Record last verified: 2009-08

Locations

KR (1)