Trial Comparing hCG Triggering Versus GnRH Agonist Triggering in PCOS Patients
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ClinicalTrials.gov Identifier: NCT01683513 |
Recruitment Status
:
Recruiting
First Posted
: September 12, 2012
Last Update Posted
: March 21, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Infertility PCOS | Drug: GnRh agonist +1500E hCG | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated 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 : | November 2011 |
Estimated Primary Completion Date : | January 2018 |

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
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- 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
- 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

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Ages Eligible for Study: | 18 Years to 38 Years (Adult) |
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

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): NCT01683513
Contact: Wim Decleer | 0032 9 3259220 | wim.decleer@janpalfijngent.be | |
Contact: Paul Devroey | 0032 9 2248070 | ivf.studie@janpalfijngent.be |
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 |
Principal Investigator: | Wim Decleer, gynecologist | IVF Centrum Jan Palfijn Gent |
Responsible Party: | Dr. Decleer Wim, gynecologist, AZ Jan Palfijn Gent |
ClinicalTrials.gov Identifier: | NCT01683513 History of Changes |
Other Study ID Numbers: |
Dr. Decleer W |
First Posted: | September 12, 2012 Key Record Dates |
Last Update Posted: | March 21, 2017 |
Last Verified: | March 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 |