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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pregnancy, Ovarian Hyperstimulation Syndrome

Intervention / Treatment
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* Procedure: final oocyte maturation trigger


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dual trigger<br>final oocyte maturation trigger using 6500 IU Ovitrelle (hCG) plus 0.2mg triptorelin acetate (GnRH agonist) | Procedure: final oocyte maturation trigger<br>* 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<br>* Other names: agonist trigger: 0.2mg triptorelin acetate (GnRH agonist);|
| Active Comparator: hCG trigger<br>final oocyte maturation trigger using 6500 IU Ovitrelle (hCG) | Procedure: final oocyte maturation trigger<br>* 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<br>* Other names: agonist trigger: 0.2mg triptorelin acetate (GnRH agonist);|
| Active Comparator: agonist trigger<br>final oocyte maturation trigger using 0.2mg triptorelin acetate (GnRH agonist) | Procedure: final oocyte maturation trigger<br>* 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<br>* Other names: agonist trigger: 0.2mg triptorelin acetate (GnRH agonist);|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dual trigger, hCG, GnRH agonist, ICSI, pregnancy, OHSS