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Completed

NCT Number: NCT01683513

Trial Comparing hCG Triggering Versus GnRH Agonist Triggering in PCOS Patients

In this study the investigators compare the traditional way of triggering with a new way in patients with Poly Cystic Ovary Syndrome (PCOS). This to reduce the risque of Ovary Hyper Stimulation Syndrome (OHSS) in In Vitro Fertilization/ IntraCytoplastic Sperm Injection (IVF/ ICSI) treatment. The investigators also compare the number of mature oocytes, embryo's and pregnancy rate.

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Key information

Conditions

Infertility Genital Diseases PCOS Urogenital Diseases

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

AZ Jan Palfijn

Ghent, Oost-vlaanderen, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ICSI patients below 38 years
  • 1, 2 and 3e IVF cycle
  • Body Mass Index (BMI) less than 32
  • PCOS patients

Exclusion criteria

  • endocrinal diseases or problems

Treatment and study plan

GnRh agonist +1500E hCG

Drug

ovulation induction with GnRh agonist and 1500E hCG one hour after egg retrieval

Primary outcomes

  1. MII oocytes

    Time frame: patients will be followed during the stimulation with an average of 10 days

    The number of mature oocytes retrieved after stimulation without creating OHSS

  2. 2 Pro Nuclei (2PN) fertilization

    Time frame: 24h after ICSI

    laboratory follow up of the fertilized egg during the first 24h

Secondary outcomes

  1. implantation rate

    Time frame: 12 weeks

    The number of pregnancies obtained wich still is the most important issue for the patients

  2. OHSS

    Time frame: one month with oocyte retrieval in the middle

    patient follow up according to subjective complaints and objective measures

Sponsors and collaborators

Lead sponsor

AZ Jan Palfijn Gent

Other

Collaborators

  • Onze Lieve Vrouw Hospital

Registry information

Official study title

Prospective Randomized Trial on GnRH Agonist Triggering Versus hCG Triggering in IVF Stimulation in PCOS Patients

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Sep 12, 2012
Registry last updated
Feb 2, 2021

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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