Trial Comparing hCG Triggering Versus GnRH Agonist Triggering in PCOS Patients

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2012 by AZ Jan Palfijn Gent.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Onze Lieve Vrouw Hospital

Information provided by (Responsible Party):

Dr. Decleer Wim, AZ Jan Palfijn Gent

ClinicalTrials.gov Identifier:

NCT01683513

First received: August 23, 2012

Last updated: September 7, 2012

Last verified: September 2012

History of Changes

Purpose

In this study the investigators compare the traditional way of triggering with a new way in PCOS patients. This to reduce the risque of OHSS in IVF/ ICSI treatment. The investigators also compare the number of oocytes, embryo's and pregnancy rate.

Condition	Intervention	Phase
Infertility PCOS	Drug: GnRh agonist +1500E hCG	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Prospective Randomized Trial on GnRH Agonist Triggering Versus hCG Triggering in IVF Stimulation in PCOS Patients

Resource links provided by NLM:

MedlinePlus related topics: Infertility

Drug Information available for: Deslorelin

U.S. FDA Resources

Further study details as provided by AZ Jan Palfijn Gent:

Primary Outcome Measures:

M2 oocytes [ Time Frame: patients will be followed during the stimulation with an average of 10 days ] [ Designated as safety issue: No ]
The number of mature oocytes retrieved after stimulation without creating OHSS
2PN fertilization [ Time Frame: 24h after ICSI ] [ Designated as safety issue: No ]
laboratory follow up of the fertilized egg during the first 24h
OHSS [ Time Frame: one month with oocyte retrieval in the middle ] [ Designated as safety issue: Yes ]
patient follow up according to subjective complaints and objective measures

Secondary Outcome Measures:

implantation rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
The number of pregnancies obtained wich still is the most important issue for the patients


Estimated Enrollment:	120
Study Start Date:	November 2011
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility


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

Criteria

Inclusion Criteria:

ICSI patients below 38 years
1, 2 and 3e IVF cycle
BMI < 32
PCOS patients

Exclusion Criteria:

endocrinal diseases or problems

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683513

Contacts


Contact: Wim Decleer	0032 9 3259220	wim.decleer@janpalfijngent.be
Contact: Paul Devroey	0032 9 2248070	ivf.studie@janpalfijngent.be

Locations


Belgium
AZ Jan Palfijn	Recruiting
Gent, Oost-vlaanderen, Belgium, 9000
Contact: Wim Decleer, gynecologist 0032 9 2243024 wim.decleer@janpalfijngent.be
Contact 0032 9 2248850 ivf.centrum@janpalfijngent.be
Principal Investigator: Wim Decleer, gynecologist

Sponsors and Collaborators

AZ Jan Palfijn Gent

Onze Lieve Vrouw Hospital

Investigators


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

More Information

No publications provided


Responsible Party:	Dr. Decleer Wim, gynecologist, AZ Jan Palfijn Gent
ClinicalTrials.gov Identifier:	NCT01683513 History of Changes
Other Study ID Numbers:	Dr. Decleer W
Study First Received:	August 23, 2012
Last Updated:	September 7, 2012
Health Authority:	Belgium: Ethics Committee

Keywords provided by AZ Jan Palfijn Gent:


OHSS mature oocytes good quality embryo's pregnancy

Additional relevant MeSH terms:


Infertility Genital Diseases, Female Genital Diseases, Male Deslorelin Triptorelin Pamoate Antineoplastic Agents Antineoplastic Agents, Hormonal Contraceptive Agents	Contraceptive Agents, Female Enzyme Inhibitors Luteolytic Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Reproductive Control Agents Therapeutic Uses

ClinicalTrials.gov processed this record on February 26, 2015

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