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Completed

NCT Number: NCT00349258

The Use of GnRH Agonist Trigger in the Prevention of OHSS

To compare the incidence of ovarian hyperstimulation syndrome (OHSS) and implantation rate between high responder patients using Gonadotropin releasing GnRH) agonist or human chorionic gonadotropin (hCG) to trigger final oocyte maturation.

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Key information

Age range

20 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Center for Advanced Reproductive Services, UCHC

Farmington, Connecticut, 06032, United States

About this study

OHSS is an iatrogenic complication of controlled ovarian hyperstimulation, which in its severe form, may result in significant morbidity. Although, there have been significant advances in in-vitro fertilization (IVF) protocols over the years, the incidence of OHSS have remained stable and there is currently no effective way of preventing this disorder.

hCG is commonly used as a substitute for the endogenous LH surge to induce final oocyte maturation in IVF. Unfortunately, hCG results in a prolonged luteotropic effect because of its long half-life which may result in a potential risk of OHSS in high-risk patients. In contrast, induction of endogenous LH surge with a GnRH agonist may result in a reduced risk of OHSS. This is due both to the shorter half-life of the endogenous LH surge and the subsequent pituitary suppression leading to early luteolysis. However, previous studies have suggested that this approach may impair implantation rates.

There are no randomized studies assessing the effect of GnRH agonist to induce oocyte maturation on the occurrence of OHSS and implantation rates in high-risk patients. The aims of this study are to compare the incidence of OHSS and implantation rates among high-risk patients who used either GnRH agonist or hCG to trigger oocyte maturation after prevention of premature LH surge with either a GnRH antagonist protocol or the dual pituitary suppression protocol, respectively.

High risk patients include women with polycystic ovarian syndrome (PCOS) or PCO morphology (PCOM) on ultrasound without the clinical or biochemical evidence of the syndrome, and patients with previous high response to gonadotropins.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 20-39
  • normal early follicular phase serum FSH (≤10.0 IU/l)
  • patients with either PCOS or PCOM undergoing their first cycle of IVF or patients with high response in a previous IVF cycle.

Exclusion criteria

  • Hypogonadotropic hypogonadism

Treatment and study plan

Leuprolide Acetate

Drug

Primary outcomes

  1. OHSS occurrence assessed one week after oocyte retrieval

  2. Implantation rate assessed at seven weeks gestation

Secondary outcomes

  1. Clinical Pregnancy rate assessed at time of ultrasound

  2. Mature oocytes assessed at time of retrieval

  3. Ovarian volume assessed one week after oocyte retrieval

Sponsors and collaborators

Lead sponsor

University of Connecticut

Other

Collaborators

  • Organon

Registry information

Official study title

A Prospective Randomized Study Comparing the Use of hCG or GnRH Agonist to Trigger Final Oocyte Maturation in High Responders Undergoing in-Vitro Fertilization Treatment

Important dates

Study start
2004
Study completion
2006
First posted
Jul 6, 2006
Registry last updated
Jul 6, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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