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

Study on the Effect of GnRH Antagonist on hCG Day on Outcomes of Controlled Ovarian Hyperstimulation With GnRH Antagonist Flexible Multiple-dose Protocols

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00571870
Enrollment
80
Registered
2007-12-12
Start date
2007-11-30
Completion date
2009-08-31
Last updated
2009-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

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.

Interventions

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

Sponsors

Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Maturity of oocytes, fertilization rate, embryo quality3 days

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026