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

Dual Trigger With Gonadotropin-releasing Hormone Agonist (GnRHa) and Human Chorionic Gonadotropin (hCG) to Optimize ICSI Reproductive Outcomes

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.

Study Overview

• Status: Withdrawn
• Conditions: Pregnancy; Ovarian Hyperstimulation Syndrome
• Intervention / Treatment: Procedure: final oocyte maturation trigger

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey, 07080
    • Antalya IVF

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
embryo implantation rate	the number of fetal sacs per embryo transferred to a patient's uterus	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
oocyte maturation	the percentage of oocytes that are at the metaphase II (nuclear mature) stage at the time of oocyte collection	12 months
Ovarian hyperstimulation syndrome	a complication arising from ovarian hyperstimulation with the use of exogenous hormones and ovulation induction	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical pregnancy	the number of patients with an ultrasound confirmed fetal heart 7 weeks after the transfer of embryos to patient uteruses	12 months

Collaborators and Investigators

• Sponsor: Antalya IVF
• Investigators: Principal Investigator: Hasan Bulut, MD, Antalya IVF; Principal Investigator: Kemal Ozgur, MD, Antalya IVF

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): September 1, 2016

Study Registration Dates

• First Submitted: November 1, 2013
• First Submitted That Met QC Criteria: November 7, 2013
• First Posted (Estimate): November 8, 2013

Study Record Updates

• Last Update Posted (Estimate): May 26, 2016
• Last Update Submitted That Met QC Criteria: May 25, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: pregnancy; GnRH agonist; hCG; ICSI; OHSS; dual trigger
• Additional Relevant MeSH Terms: Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Ovarian Hyperstimulation Syndrome; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Luteolytic Agents; Triptorelin Pamoate; Chorionic Gonadotropin
• Other Study ID Numbers: AntalyaIVF-RCT-dual trigger; App. No. 01042013/103 (Other Identifier: Turkish Health Ministry Ethics Committee/Akdeniz University Ethics Committee)