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

Not Applicable

Withdrawn

• Conditions: Pregnancy; Ovarian Hyperstimulation Syndrome
• Interventions: Procedure: final oocyte maturation trigger

• Registration Number: NCT01979341
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-11-01
• Study First Submitted QC: 2013-11-07
• Study First Posted: 2013-11-08
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-25
• Last Update Posted: 2016-05-26
• Primary Completion: 2016-06
• Study Completion: 2016-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
embryo implantation rate	12 months	the number of fetal sacs per embryo transferred to a patient's uterus

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Antalya IVF; 🇹🇷 Antalya, Turkey