Trial Comparing hCG Triggering Versus GnRH Agonist Triggering in PCOS Patients

• Sponsor: AZ Jan Palfijn Gent (Other)
• Overall Status: Completed
• CT.gov ID: NCT01683513
• Collaborator: Onze Lieve Vrouw Hospital (Other)
• Enrollment: 120
• Location: 1
• Arms: 2
• Duration (Months): 39
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Infertility; PCOS	Drug: GnRh agonist +1500E hCG	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Prospective Randomized Trial on GnRH Agonist Triggering Versus hCG Triggering in IVF Stimulation in PCOS Patients
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Feb 1, 2015
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: humaan chorion gonadotropine ovulation induction with 5000E hCG
Active Comparator: GnRH agonist + 1500E hCG ovulation induction with GnRH agonist and 1500E hCG one hour after egg retrieval	Drug: GnRh agonist +1500E hCG; ovulation induction with GnRh agonist and 1500E hCG one hour after egg retrieval

Outcome Measures

Primary Outcome Measures

1. MII oocytes [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 [24h after ICSI]

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

Secondary Outcome Measures

1. implantation rate [12 weeks]

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

2. OHSS [one month with oocyte retrieval in the middle]

   patient follow up according to subjective complaints and objective measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 38 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AZ Jan Palfijn	Gent	Oost-vlaanderen	Belgium	9000

Sponsors and Collaborators

• AZ Jan Palfijn Gent
• Onze Lieve Vrouw Hospital

Investigators

• Principal Investigator: Wim Decleer, gynecologist, IVF Centrum Jan Palfijn Gent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Decleer Wim, gynecologist, AZ Jan Palfijn Gent
• ClinicalTrials.gov Identifier: NCT01683513
• Other Study ID Numbers: Dr. Decleer W
• First Posted: Sep 12, 2012
• Last Update Posted: Feb 2, 2021
• Last Verified: Feb 1, 2021

• Keywords provided by Dr. Decleer Wim, gynecologist, AZ Jan Palfijn Gent: OHSS; mataphase II oocytes (MII); good quality embryo's; pregnancy
• Additional relevant MeSH terms: Infertility

Study Results

No Results Posted as of Feb 2, 2021