Trial Comparing hCG Triggering Versus GnRH Agonist Triggering in PCOS Patients

This study is currently recruiting participants.

See

Contacts and Locations

Verified March 2017 by Dr. Decleer Wim, AZ Jan Palfijn Gent

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: March 20, 2017

Last verified: March 2017

History of Changes

Purpose

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


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: No masking 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:

Drug Information available for: Deslorelin

U.S. FDA Resources

Further study details as provided by Dr. Decleer Wim, AZ Jan Palfijn Gent:

Primary Outcome Measures:

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 Pro Nuclei (2PN) fertilization [ Time Frame: 24h after ICSI ]
laboratory follow up of the fertilized egg during the first 24h

Secondary Outcome Measures:

implantation rate [ Time Frame: 12 weeks ]
The number of pregnancies obtained wich still is the most important issue for the patients
OHSS [ Time Frame: one month with oocyte retrieval in the middle ]
patient follow up according to subjective complaints and objective measures


Estimated Enrollment:	120
Study Start Date:	November 2011
Estimated Primary Completion Date:	January 2018 (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 (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

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 2248853 wim.decleer@janpalfijngent.be
Contact 0032 9 2248851 ivf.studie@janpalfijngent.be
Principal Investigator: Wim Decleer, gynecologist
Sub-Investigator: Kaan Osamanagaoglu, gynecologist, MD

Sponsors and Collaborators

AZ Jan Palfijn Gent

Onze Lieve Vrouw Hospital

Investigators


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

More Information


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:	March 20, 2017

Keywords provided by Dr. Decleer Wim, AZ Jan Palfijn Gent:


OHSS mataphase II oocytes (MII) good quality embryo's pregnancy

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on July 21, 2017

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