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Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist

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ClinicalTrials.gov Identifier: NCT01607203
Recruitment Status : Completed
First Posted : May 30, 2012
Results First Posted : February 19, 2015
Last Update Posted : February 19, 2015
Sponsor:
Collaborator:
Onze Lieve Vrouw Hospital
Information provided by (Responsible Party):
Dr. Decleer Wim, AZ Jan Palfijn Gent

Study Description
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Brief Summary:
The purpose of this study is to see whether patients triggered with only human Chorion Gonadotropin (hCG) have higher number of Metaphase II oocytes (MII) and implantation rate than patients triggered with hCG combined with Gonadotropin Releasing Hormone (GnRH) agonist.

Condition or disease Intervention/treatment Phase
Infertility Drug: Decapeptyl Daily Drug: pregnyl Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Controlled Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist
Study Start Date : November 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: hCG
5000 IU Pregnyl SC
 Drug: pregnyl
5000 IU SC
Active Comparator: hCG and GnRH agonist
5000 IU Pregnyl SC + 0.2 mg Decapeptyl daily SC
 Drug: Decapeptyl Daily
Decapeptyl 0.2 mg SC once 1day
Other Name: Gonapeptyl

Drug: pregnyl
5000 IU SC


Outcome Measures
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Primary Outcome Measures :
  1. MII Oocytes [ Time Frame: 3 weeks ]
    the number of mature oocytes retrieved


Secondary Outcome Measures :
  1. Pregnancy Rate [ Time Frame: 12 weeks ]
    the number of pregnancies obtained, wich still is the most important issue for the patients

  2. Patients With Cryopreserved Embryos [ Time Frame: 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   up to 38 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Intra-cytoplasmic sperm injection (ICSI) patients below 38 years
  • 1,2 or 3 rd IVF-cycle

Exclusion Criteria:

  • polycystic ovary syndrome (PCOS) patients
  • patients with endocrinological diseases or problems
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01607203


Locations
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Belgium
A Z Jan Palfijn
Gent, Oost-vlaanderen, Belgium, 9000
Sponsors and Collaborators
AZ Jan Palfijn Gent
Onze Lieve Vrouw Hospital
Investigators
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Principal Investigator: Wim Decleer, gynacologist IVF Centrum Jan Palfijn Gent
More Information
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Responsible Party: Dr. Decleer Wim, gynaecologist, AZ Jan Palfijn Gent
ClinicalTrials.gov Identifier: NCT01607203    
Other Study ID Numbers: Dr. Decleer Wim
First Posted: May 30, 2012    Key Record Dates
Results First Posted: February 19, 2015
Last Update Posted: February 19, 2015
Last Verified: February 2015
Keywords provided by Dr. Decleer Wim, AZ Jan Palfijn Gent:
ovarian hyper stimulation syndrome (OHSS)
metaphase II oocytes (MII)
good quality embryo's
implantation
pregnancy
Additional relevant MeSH terms:
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Infertility
Triptorelin Pamoate
Chorionic Gonadotropin
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
 Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Antineoplastic Agents, Hormonal
Antineoplastic Agents