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

Primary Purpose

Pregnancy, Ovarian Hyperstimulation Syndrome

Status
Withdrawn
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
final oocyte maturation trigger
Sponsored by
Antalya IVF
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pregnancy focused on measuring dual trigger, hCG, GnRH agonist, ICSI, pregnancy, OHSS

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Antalya IVF

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Dual trigger

hCG trigger

agonist trigger

Arm Description

final oocyte maturation trigger using 6500 IU Ovitrelle (hCG) plus 0.2mg triptorelin acetate (GnRH agonist)

final oocyte maturation trigger using 6500 IU Ovitrelle (hCG)

final oocyte maturation trigger using 0.2mg triptorelin acetate (GnRH agonist)

Outcomes

Primary Outcome Measures

embryo implantation rate
the number of fetal sacs per embryo transferred to a patient's uterus

Secondary Outcome Measures

oocyte maturation
the percentage of oocytes that are at the metaphase II (nuclear mature) stage at the time of oocyte collection
Ovarian hyperstimulation syndrome
a complication arising from ovarian hyperstimulation with the use of exogenous hormones and ovulation induction

Full Information

First Posted
November 1, 2013
Last Updated
May 25, 2016
Sponsor
Antalya IVF
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1. Study Identification

Unique Protocol Identification Number
NCT01979341
Brief Title
The Effect of a Dual Trigger on Intracytoplasmic Sperm Injection (ICSI) Reproductive Outcomes
Official Title
Dual Trigger With Gonadotropin-releasing Hormone Agonist (GnRHa) and Human Chorionic Gonadotropin (hCG) to Optimize ICSI Reproductive Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Withdrawn
Why Stopped
treatment strategy changed
Study Start Date
October 2013 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
September 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Antalya IVF

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Ovarian Hyperstimulation Syndrome
Keywords
dual trigger, hCG, GnRH agonist, ICSI, pregnancy, OHSS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dual trigger
Arm Type
Active Comparator
Arm Description
final oocyte maturation trigger using 6500 IU Ovitrelle (hCG) plus 0.2mg triptorelin acetate (GnRH agonist)
Arm Title
hCG trigger
Arm Type
Active Comparator
Arm Description
final oocyte maturation trigger using 6500 IU Ovitrelle (hCG)
Arm Title
agonist trigger
Arm Type
Active Comparator
Arm Description
final oocyte maturation trigger using 0.2mg triptorelin acetate (GnRH agonist)
Intervention Type
Procedure
Intervention Name(s)
final oocyte maturation trigger
Other Intervention Name(s)
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)
Intervention Description
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
Primary Outcome Measure Information:
Title
embryo implantation rate
Description
the number of fetal sacs per embryo transferred to a patient's uterus
Time Frame
12 months
Secondary Outcome Measure Information:
Title
oocyte maturation
Description
the percentage of oocytes that are at the metaphase II (nuclear mature) stage at the time of oocyte collection
Time Frame
12 months
Title
Ovarian hyperstimulation syndrome
Description
a complication arising from ovarian hyperstimulation with the use of exogenous hormones and ovulation induction
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
clinical pregnancy
Description
the number of patients with an ultrasound confirmed fetal heart 7 weeks after the transfer of embryos to patient uteruses
Time Frame
12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hasan Bulut, MD
Organizational Affiliation
Antalya IVF
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kemal Ozgur, MD
Organizational Affiliation
Antalya IVF
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antalya IVF
City
Antalya
ZIP/Postal Code
07080
Country
Turkey

12. IPD Sharing Statement

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

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