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NCT01683513 Clinical Trial

Trial Comparing hCG Triggering Versus GnRH Agonist Triggering in PCOS Patients

Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01683513
Other study ID # Dr. Decleer W
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 2011
Est. completion date February 2015

Study information
Verified date February 2021
Source AZ Jan Palfijn Gent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 38 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• GnRh agonist +1500E hCG
ovulation induction with GnRh agonist and 1500E hCG one hour after egg retrieval

Locations
Country Name City State
Belgium AZ Jan Palfijn Gent Oost-vlaanderen

Sponsors (2)
Lead Sponsor Collaborator
AZ Jan Palfijn Gent Onze Lieve Vrouw Hospital

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary MII oocytes The number of mature oocytes retrieved after stimulation without creating OHSS patients will be followed during the stimulation with an average of 10 days
Primary 2 Pro Nuclei (2PN) fertilization laboratory follow up of the fertilized egg during the first 24h 24h after ICSI
Secondary implantation rate The number of pregnancies obtained wich still is the most important issue for the patients 12 weeks
Secondary OHSS patient follow up according to subjective complaints and objective measures one month with oocyte retrieval in the middle
See also
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Completed NCT03678597 - Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB) N/A
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