Repeated Injection of GnRH Agonist 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 repeated injection of GnRH agonist for preventing OHSS and maintaining clinical outcome in high risk patients who receive controlled ovarian stimulation in GnRH antagonist protocol.

Detailed Description
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This was a prospective cohort study of all women attending the Center for Reproductive Medicine, Department of Gynecology and Obstetrics, Nanfang Hospital, affiliated with Southern Medical University for in vitro fertilization and/or intracytoplasmic sperm injection . Women at high risk of OHSS who received IVF and/or intracytoplasmic sperm injection (ICSI) treatment with a flexible GnRH antagonist protocol were recruited to participate in this study. All patients underwent standard ovarian stimulation protocol with gonadotropins, standard individualized adjustment of medication dose, and standard egg retrieval procedure. Patients were triggered with a single bolus of 0.2 mg triptorelin at night and had second injection of 0.2 mg triptorelin 12 hours later when the criteria for administration of the ovulation trigger were met.

Official Title
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Repeated Injection of GnRH Agonist for Triggering 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


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: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Repeated GnRHa<br>Patients were triggered with repeated GnRHa | Drug: triptorelin<br>* 0.2 mg, ih, at night and 0.2 mg, ih, 12 hours later when at least one of the following criteria was reached: (i) serum E2 ≥3500 pg/ml, (ii) ≥18 follicles measuring ≥11 mm.<br>* Other names: Diphereline;|

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 repeated 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 the first trigger with GnRHa) | 
| 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 ICSI. | 24 hours post oocyte retrieval day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum luteinizing hormone level 12 hours post first trigger |  | 12 hours post trigger with the first injection of GnRHa | 
| serum luteinizing hormone level 24 hours post first trigger |  | 24 hours post the first injection of GnRHa | 
| 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