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
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Infertility
• PCOS

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