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

Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00571870
• Other study ID #: B-0710-050-001
• Status: Completed
• Phase: N/A
• First received: December 10, 2007
• Last updated: August 20, 2009
• Start date: November 2007
• Est. completion date: August 2009

Study information

• Verified date: August 2009
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maturity of oocytes, fertilization rate, embryo quality		3 days	No