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Completed

NCT Number: NCT00835523

Ovarian Hyperstimulation Syndrome (OHSS) Prevention With Agonist

The aim of the study is to explore the concept of GnRH-agonist triggering in combination with elective cryopreservation of all 2PN oocytes at larger scale in a pragmatic clinical setting. The question asked is: "Does GnRH-agonist triggering and cryopreservation work", in terms of efficacy and safety, when applied to a larger cohort of patients, and by a number of different centres with different clinical routines.

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Key information

Conditions

Ovarian Hyperstimulation Syndrome Adnexal Diseases Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Ovarian Diseases Urogenital Diseases

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IVF-Augsburg, Augsburg, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Indication for IVF with ICSI
  • Age < 40 years
  • < 4 failed previous IVF attempts with embryo transfer
  • ovarian stimulation with GnRH-antagonist and gonadotrophins
  • >20 follicles >11 mm in mean diameter or E2 >4500 pg/ml on the day , on which it was planned to administer hCG
  • willing to participate and able to consent
  • patient has not previously received GnRH-agonist as a trigger of final oocyte maturation

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Cumulative ongoing pregnancy rate (10-12 GWs) per patient within 12 months

    Time frame: 12 months after recruitment

Secondary outcomes

  1. ongoing pregnancy rate/frozen-thawed ET

    Time frame: 12 months after recruitment

  2. Ongoing pregnancy rate/first frozen-thawed ET

    Time frame: 12 months after recruitment

  3. time to pregnancy in weeks

    Time frame: 12 months after recruitment

  4. incidence of OHSS III°

    Time frame: 12 months after recruitment

  5. number of cumulus-oocyte-complexes

    Time frame: 12 months after recruitment

  6. fertilization rate (number COCs/number of 2 PN oocytes

    Time frame: 12 months after recruitment

  7. survival rate (number of vital embryos/number of frozen 2 PN oocytes

    Time frame: 12 months after recruitment

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Registry information

Official study title

OHSS Prevention by GnRH-agonist Triggering of Final Oocyte Maturation and Cryoperservation of All Two-pronucleate Oocytes in Women Undergoing Stimulation for IVF With Gonadotrophins and GnRH-analogues: a Prospective, Observational, Multicentric, Clinical Cohort Study

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 3, 2009
Registry last updated
Jun 14, 2012

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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