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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Withdrawn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

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

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

NCT ID

NCT01979341

First Posted

November 1, 2013

Last Updated

May 25, 2016

Sponsor

Antalya IVF

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

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

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

Learn more about this trial

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

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