Dual Trigger to Reduce Ovarian Hyperstimulation Syndrome

Study Overview
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Brief Summary
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Gonadotropin releasing hormone (GnRH) agonist is sufficient for triggering final oocyte maturation in GnRH antagonist protocol and can significantly reduce incidence of ovarian hyperstimulation syndrome (OHSS) in high-risk patients. However, lower oocyte yield was reported in patients with lower luteinizing hormone (LH) level post trigger with single injection of GnRH agonist, which might be related to the shorter duration and lower amount of LH induced by GnRH agonist. Our aim is to study dual trigger with GnRH agonist and human chorionic gonadotropin (hCG) for preventing OHSS and maintaining clinical outcome in high risk patients who receive controlled ovarian stimulation in GnRH antagonist protocol.

Official Title
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Dual Trigger With GnRH Agonist and Human Chorionic Gonadotropin for Final Oocyte Maturation in Patients at High Risk of Ovarian Hyperstimulation Syndrome in GnRH Antagonist Protocol

Conditions
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Infertility and at High Risk of OHSS

Intervention / Treatment
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* Drug: triptorelin
* Drug: hCG
* Drug: hCG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with polycystic ovarian syndrome patients with polycystic ovarian morphology on ultrasound patients who previously experienced an ovarian stimulation cycle, with a high response to gonadotrophins Exclusion Criteria: patients undergoing coasting patients with past ovarian surgery

Ages Eligible for Study
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Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.2mg triptorelin and 500 IU hCG<br>Patients were triggered with 0.2mg triptorelin and 500 IU hCG | Drug: triptorelin<br>* 0.2 mg triptorelin, ih<br>* Other names: triptorelin: Diphereline;Drug: hCG<br>* 500IU hCG, im<br>|
| Experimental: 0.2mg triptorelin and 1000 IU hCG<br>Patients were triggered with 0.2mg triptorelin and 1000 IU hCG | Drug: triptorelin<br>* 0.2 mg triptorelin, ih<br>* Other names: triptorelin: Diphereline;Drug: hCG<br>* 1000 IU hCG, im<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate per transfer cycle |  | 1month post embryo transfer | 
| numbers of patients having OHSS |  | 2 weeks post trigger with dual GnRHa | 
| oocyte yield | Oocyte yield was defined as the ratio of the total number of collected oocytes to the number of follicles measuring ≥10 mm on the day of oocyte retrieval. | oocyte retrieval day (34 to 38 hours post trigger with GnRHa and hCG) | 
| Oocyte maturity | Oocyte maturity was defined as the ratio of metaphase II (MII) oocytes to the number of collected oocytes in the patients undergoing with intracytoplasmic sperm injection (ICSI). | 24 hours post oocyte retrieval day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum luteinizing hormone level 12 hours post trigger |  | 12 hours post trigger | 
| serum hCG level 12 hours post trigger |  | 12 hours post trigger | 
| fertilization rate | Fertilization rate was defined as the ratio of normal fertilized oocytes (2PNs) to the number of oocytes used for fertilization (i.e. the denominator in IVF in calculating fertilization rate is all oocytes recovered, but in ICSI it is calculated using only the number of MII oocytes). | 48 hours post IVF/ICSI | 
| implantation rate |  | 1 month post embryo transfer | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian Hyperstimulation Syndrome, Luteinizing Hormone, Polycystic Ovarian Syndrome, Ovarian Yield, Ovarian Maturity, Gonadotropin Releasing Hormone Agonist, Human Chorionic Gonadotropin