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The Effect of a Dual Trigger on Intracytoplasmic Sperm Injection (ICSI) Reproductive Outcomes

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ClinicalTrials.gov Identifier: NCT01979341
Recruitment Status : Withdrawn (treatment strategy changed)
First Posted : November 8, 2013
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):
Kevin Coetzee, Antalya IVF

Brief Summary:

The use of antagonist controlled ovarian stimulation protocols has allowed the use of GnRH agonist to be used for final oocyte maturation. The use of GnRH agonist as ovulation trigger has been shown to reduce the risks for ovarian hyperstimulation syndrome (OHSS), but its sole use results in reduced embryo implantation due to luteal phase insufficiency. The combination of GnRH agonist and variable doses of hCG for final oocyte maturation has been shown to overcome the luteal phase insufficiency effecting endometrial receptivity.

In this study the investigators will test the hypothesis that using GnRH agonist (0.2mg Triptorelin) and a full dose of hCG (6500IU Ovitrelle) for final oocyte maturation in normoresponders will increase oocyte maturity, embryo quality and embryo implantation and reduce ovarian hyperstimulation syndrome, as compared to the traditional hCG (full dose) alone trigger.


Condition or disease Intervention/treatment Phase
Pregnancy Ovarian Hyperstimulation Syndrome Procedure: final oocyte maturation trigger Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Dual Trigger With Gonadotropin-releasing Hormone Agonist (GnRHa) and Human Chorionic Gonadotropin (hCG) to Optimize ICSI Reproductive Outcomes
Study Start Date : October 2013
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dual trigger
final oocyte maturation trigger using 6500 IU Ovitrelle (hCG) plus 0.2mg triptorelin acetate (GnRH agonist)
Procedure: final oocyte maturation trigger
when ≥3 follicles reach 17mm patients will be randomized to receive one of two types of trigger for final oocyte maturation; dual trigger: GnRH agonist plus hCG (both full doses) hCG only: full dose of hCG only
Other Names:
  • dual trigger: 6500 IU Ovitrelle (hCG) plus 0.2mg triptorelin acetate (GnRH agonist)
  • hCG trigger: 6500 IU Ovitrelle (hCG)
  • agonist trigger: 0.2mg triptorelin acetate (GnRH agonist)

Active Comparator: hCG trigger
final oocyte maturation trigger using 6500 IU Ovitrelle (hCG)
Procedure: final oocyte maturation trigger
when ≥3 follicles reach 17mm patients will be randomized to receive one of two types of trigger for final oocyte maturation; dual trigger: GnRH agonist plus hCG (both full doses) hCG only: full dose of hCG only
Other Names:
  • dual trigger: 6500 IU Ovitrelle (hCG) plus 0.2mg triptorelin acetate (GnRH agonist)
  • hCG trigger: 6500 IU Ovitrelle (hCG)
  • agonist trigger: 0.2mg triptorelin acetate (GnRH agonist)

Active Comparator: agonist trigger
final oocyte maturation trigger using 0.2mg triptorelin acetate (GnRH agonist)
Procedure: final oocyte maturation trigger
when ≥3 follicles reach 17mm patients will be randomized to receive one of two types of trigger for final oocyte maturation; dual trigger: GnRH agonist plus hCG (both full doses) hCG only: full dose of hCG only
Other Names:
  • dual trigger: 6500 IU Ovitrelle (hCG) plus 0.2mg triptorelin acetate (GnRH agonist)
  • hCG trigger: 6500 IU Ovitrelle (hCG)
  • agonist trigger: 0.2mg triptorelin acetate (GnRH agonist)




Primary Outcome Measures :
  1. embryo implantation rate [ Time Frame: 12 months ]
    the number of fetal sacs per embryo transferred to a patient's uterus


Secondary Outcome Measures :
  1. oocyte maturation [ Time Frame: 12 months ]
    the percentage of oocytes that are at the metaphase II (nuclear mature) stage at the time of oocyte collection

  2. Ovarian hyperstimulation syndrome [ Time Frame: 12 months ]
    a complication arising from ovarian hyperstimulation with the use of exogenous hormones and ovulation induction


Other Outcome Measures:
  1. clinical pregnancy [ Time Frame: 12 months ]
    the number of patients with an ultrasound confirmed fetal heart 7 weeks after the transfer of embryos to patient uteruses



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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age; < 40 years
  • Cycle number; cycles 1 or 2
  • Antral follicle count; >10 and <25
  • BMI; >18 and <30
  • Normogonadotrophic cycle length; 24 to 25 days
  • Male; ejaculated semen only

Exclusion Criteria:

  • Presence of endocrine disorders; (diabetes mellitus, hyperprolactinemia, thyroid dysfunction, congenital adrenal hyperplasia, Cushing syndrome, or polycystic ovary syndrome)
  • Previous major uterine surgery (that would affect endometrial receptivity)

Secondary exclusion criteria

  • <5 follicles at the time of trigger
  • <2 full formed blastocyst on day 5 of embryo culture

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): NCT01979341


Locations
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Turkey
Antalya IVF
Antalya, Turkey, 07080
Sponsors and Collaborators
Antalya IVF
Investigators
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Principal Investigator: Hasan Bulut, MD Antalya IVF
Principal Investigator: Kemal Ozgur, MD Antalya IVF

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Responsible Party: Kevin Coetzee, Scientific Advisor, Antalya IVF
ClinicalTrials.gov Identifier: NCT01979341     History of Changes
Other Study ID Numbers: AntalyaIVF-RCT-dual trigger
App. No. 01042013/103 ( Other Identifier: Turkish Health Ministry Ethics Committee/Akdeniz University Ethics Committee )
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: May 26, 2016
Last Verified: May 2016
Keywords provided by Kevin Coetzee, Antalya IVF:
dual trigger
hCG
GnRH agonist
ICSI
pregnancy
OHSS
Additional relevant MeSH terms:
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Chorionic Gonadotropin
Ovarian Hyperstimulation Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Triptorelin Pamoate
Deslorelin
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents