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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

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.


Condition or disease Intervention/treatment Phase
Infertility and at High Risk of OHSS Drug: triptorelin Drug: hCG Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : July 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 0.2mg triptorelin and 500 IU hCG
Patients were triggered with 0.2mg triptorelin and 500 IU hCG
Drug: triptorelin
0.2 mg triptorelin, ih
Other Name: triptorelin: Diphereline

Drug: hCG
500IU hCG, im

Experimental: 0.2mg triptorelin and 1000 IU hCG
Patients were triggered with 0.2mg triptorelin and 1000 IU hCG
Drug: triptorelin
0.2 mg triptorelin, ih
Other Name: triptorelin: Diphereline

Drug: hCG
1000 IU hCG, im




Primary Outcome Measures :
  1. clinical pregnancy rate per transfer cycle [ Time Frame: 1month post embryo transfer ]
  2. numbers of patients having OHSS [ Time Frame: 2 weeks post trigger with dual GnRHa ]
  3. 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.

  4. 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).


Secondary Outcome Measures :
  1. serum luteinizing hormone level 12 hours post trigger [ Time Frame: 12 hours post trigger ]
  2. serum hCG level 12 hours post trigger [ Time Frame: 12 hours post trigger ]
  3. 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).

  4. implantation rate [ Time Frame: 1 month post embryo transfer ]


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Ages Eligible for Study:   up to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02022228


Contacts
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Contact: Shi-Ling Chen, M.D., Ph.D. +86-20-62787604 chensl_92@163.com

Locations
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China, Guangdong
Center for Reproductive Medicine, Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Shi-Ling Chen, M.D., Ph.D.    +86-20-62787604    chensl_92@163.com   
Principal Investigator: Shi-Ling Chen, M.D., Ph.D.         
Sponsors and Collaborators
Chenshiling
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
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Study Chair: Shi-Ling Chen, M.D., Ph.D. Nanfang Hospital of Southern Medical University

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Responsible Party: Chenshiling, Professor, M.D., Ph.D., Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT02022228     History of Changes
Other Study ID Numbers: Dual Trigger
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: December 27, 2013
Last Verified: October 2013
Keywords provided by Chenshiling, Nanfang Hospital of Southern Medical University:
Ovarian Hyperstimulation Syndrome
Luteinizing Hormone
Polycystic Ovarian Syndrome
Ovarian Yield
Ovarian Maturity
Gonadotropin Releasing Hormone Agonist
Human Chorionic Gonadotropin
Additional relevant MeSH terms:
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Infertility
Ovarian Hyperstimulation Syndrome
Syndrome
Disease
Pathologic Processes
Genital Diseases, Male
Genital Diseases, Female
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Triptorelin Pamoate
Chorionic Gonadotropin
Physiological Effects of Drugs
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents