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Completed

NCT Number: NCT01268761

GnRH Antagonist for Treatment of Early Ovarian Hyperstimulation Syndrome

The aim of this study is to analyze the effectiveness of GnRh antagonist in the treatment of early ovarian hyperstimulation syndrome.

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Key information

Conditions

Ovarian Hyperstimulation Syndrome Adnexal Diseases Effects of Gonadotropin Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Oocyte Maturation Ovarian Diseases Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

IVI Valencia

Valencia, 46015, Spain

About this study

Ovarian hyperstimulation syndrome (OHSS) is a serious complication of ovarian stimulation protocols. Gonadotrophin-releasing hormone (GnRH) antagonist administration in the luteal phase was recently proposed as a new approach for the management of patients with established severe OHSS We analyze the response of egg donors with moderate- severe early ovarian hyperstimulation syndrome after a GnRH antagonist stimulation protocol to the administration of a daily doses of GnRH antagonist (Cetrorelix 0.25) during 7 days after the second day of oocyte retrieval compared with placebo (saline solution).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Egg donors
  • Volunteers.
  • 18-35 years old
  • Healthy
  • BMI < 30
  • OHHS after oocyte retrieval defined as ascitis > 9 cm2 associate to abdominal pain, sickness, abdominal distention,or haematocrit (Ht) >45% an white blood cell count >15,000/mm3 or creatine > 1.2 mg/dl or transaminases > 40 IU/liter

Exclusion criteria

  • BMI > 30
  • Allergy to GnRH antagonist

Treatment and study plan

GnRH antagonist (Cetrorelix)

Drug

•GnRH antagonist (Cetrorelix 0.25) during 7 days beginning administration the second day of oocyte retrieval

Placebo (Saline solution)

Drug
  • Placebo (saline solution) 1 ampoule every 24 hours during 7 days beginning administration the second day of oocyte retrieval

Primary outcomes

  1. Ultrasound

    Time frame: one week

    Ultrasound measurements: ascitis and ovarian size

  2. Blood measurements

    Time frame: one week

    Blood measurements: hyperstimulation biomarkers, liver and kidney function and hormonal profile.

Sponsors and collaborators

Lead sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Other

Registry information

Official study title

Usefulness of GnRH Antagonist Administration in the Treatment of Early Ovarian Hyperstimulation Syndrome

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 31, 2010
Registry last updated
Sep 19, 2013

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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