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Trial Comparing hCG Triggering Versus hCG Associated With GnRH Agonist

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01607203
First Posted: May 30, 2012
Last Update Posted: February 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Onze Lieve Vrouw Hospital
Information provided by (Responsible Party):
Dr. Decleer Wim, AZ Jan Palfijn Gent
  Purpose
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 Intervention Phase
Infertility Drug: Decapeptyl Daily Drug: pregnyl Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

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


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

  • Patients With Cryopreserved Embryos [ Time Frame: 4 weeks ]

Enrollment: 120
Study Start Date: November 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
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
Belgium
A Z Jan Palfijn
Gent, Oost-vlaanderen, Belgium, 9000
Sponsors and Collaborators
AZ Jan Palfijn Gent
Onze Lieve Vrouw Hospital
Investigators
Principal Investigator: Wim Decleer, gynacologist IVF Centrum Jan Palfijn Gent
  More Information

Responsible Party: Dr. Decleer Wim, gynaecologist, AZ Jan Palfijn Gent
ClinicalTrials.gov Identifier: NCT01607203     History of Changes
Other Study ID Numbers: Dr. Decleer Wim
First Submitted: May 4, 2012
First Posted: May 30, 2012
Results First Submitted: December 30, 2013
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:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Deslorelin
Triptorelin Pamoate
Chorionic Gonadotropin
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