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

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Seoul National University

Status

Completed

Conditions

Infertility

Treatments

Drug: cetrorelix acetate

Study type

Interventional

Funder types

Other

Identifiers

NCT00571870
B-0710-050-001

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

80 participants in 2 patient groups

A
Active Comparator group
Description:
Stimulated as conventional protocol
Treatment:
Drug: cetrorelix acetate
B
Experimental group
Description:
GnRH antagonist stopped one day earlier than conventional protocol
Treatment:
Drug: cetrorelix acetate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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