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Dual Trigger to Reduce Ovarian Hyperstimulation Syndrome

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ClinicalTrials.gov Identifier: NCT02022228
Recruitment Status : Unknown
Verified October 2013 by Chenshiling, Nanfang Hospital of Southern Medical University.
Recruitment status was:  Recruiting
First Posted : December 27, 2013
Last Update Posted : December 27, 2013
Sponsor:
Collaborators:
National Natural Science Foundation of China
Comprehensive Strategic Cooperation Project of Guangdong Province and Chinese Academy of Science
Guangzhou Science and Technology Program key projects
National Key Basic Research Development Plan of China
Information provided by (Responsible Party):
Chenshiling, Nanfang Hospital of Southern Medical University

Tracking Information
First Submitted Date  ICMJE December 15, 2013
First Posted Date  ICMJE December 27, 2013
Last Update Posted Date December 27, 2013
Study Start Date  ICMJE July 2012
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 20, 2013)
  • clinical pregnancy rate per transfer cycle [ Time Frame: 1month post embryo transfer ]
  • numbers of patients having OHSS [ Time Frame: 2 weeks post trigger with dual GnRHa ]
  • oocyte yield [ Time Frame: oocyte retrieval day (34 to 38 hours post trigger with GnRHa and hCG) ]
    Oocyte yield was defined as the ratio of the total number of collected oocytes to the number of follicles measuring ≥10 mm on the day of oocyte retrieval.
  • Oocyte maturity [ Time Frame: 24 hours post oocyte retrieval day ]
    Oocyte maturity was defined as the ratio of metaphase II (MII) oocytes to the number of collected oocytes in the patients undergoing with intracytoplasmic sperm injection (ICSI).
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2013)
  • serum luteinizing hormone level 12 hours post trigger [ Time Frame: 12 hours post trigger ]
  • serum hCG level 12 hours post trigger [ Time Frame: 12 hours post trigger ]
  • fertilization rate [ Time Frame: 48 hours post IVF/ICSI ]
    Fertilization rate was defined as the ratio of normal fertilized oocytes (2PNs) to the number of oocytes used for fertilization (i.e. the denominator in IVF in calculating fertilization rate is all oocytes recovered, but in ICSI it is calculated using only the number of MII oocytes).
  • implantation rate [ Time Frame: 1 month post embryo transfer ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dual Trigger to Reduce Ovarian Hyperstimulation Syndrome
Official Title  ICMJE Dual Trigger With GnRH Agonist and Human Chorionic Gonadotropin for Final Oocyte Maturation in Patients at High Risk of Ovarian Hyperstimulation Syndrome in GnRH Antagonist Protocol
Brief Summary

Gonadotropin releasing hormone (GnRH) agonist is sufficient for triggering final oocyte maturation in GnRH antagonist protocol and can significantly reduce incidence of ovarian hyperstimulation syndrome (OHSS) in high-risk patients.

However, lower oocyte yield was reported in patients with lower luteinizing hormone (LH) level post trigger with single injection of GnRH agonist, which might be related to the shorter duration and lower amount of LH induced by GnRH agonist.

Our aim is to study dual trigger with GnRH agonist and human chorionic gonadotropin (hCG) for preventing OHSS and maintaining clinical outcome in high risk patients who receive controlled ovarian stimulation in GnRH antagonist protocol.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Infertility and at High Risk of OHSS
Intervention  ICMJE
  • Drug: triptorelin
    0.2 mg triptorelin, ih
    Other Name: triptorelin: Diphereline
  • Drug: hCG
    1000 IU hCG, im
  • Drug: hCG
    500IU hCG, im
Study Arms  ICMJE
  • Experimental: 0.2mg triptorelin and 500 IU hCG
    Patients were triggered with 0.2mg triptorelin and 500 IU hCG
    Interventions:
    • Drug: triptorelin
    • Drug: hCG
  • Experimental: 0.2mg triptorelin and 1000 IU hCG
    Patients were triggered with 0.2mg triptorelin and 1000 IU hCG
    Interventions:
    • Drug: triptorelin
    • Drug: hCG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 20, 2013)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2016
Estimated Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • patients with polycystic ovarian syndrome
  • patients with polycystic ovarian morphology on ultrasound
  • patients who previously experienced an ovarian stimulation cycle, with a high response to gonadotrophins

Exclusion Criteria:

  • patients undergoing coasting
  • patients with past ovarian surgery
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE up to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02022228
Other Study ID Numbers  ICMJE Dual Trigger
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chenshiling, Nanfang Hospital of Southern Medical University
Study Sponsor  ICMJE Chenshiling
Collaborators  ICMJE
  • National Natural Science Foundation of China
  • Comprehensive Strategic Cooperation Project of Guangdong Province and Chinese Academy of Science
  • Guangzhou Science and Technology Program key projects
  • National Key Basic Research Development Plan of China
Investigators  ICMJE
Study Chair: Shi-Ling Chen, M.D., Ph.D. Nanfang Hospital of Southern Medical University
PRS Account Nanfang Hospital of Southern Medical University
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP