Repeated Injection of GnRH Agonist to Reduce Ovarian Hyperstimulation Syndrome

Not Applicable

• Conditions: Infertility and at High Risk of OHSS
• Interventions: Drug: triptorelin

• Registration Number: NCT02022241
• Lead Sponsor: Chenshiling

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-07
• Status Verified: 2013-12
• Study First Submitted: 2013-12-15
• Study First Submitted QC: 2013-12-20
• Last Update Submitted: 2013-12-20
• Study First Posted: 2013-12-27
• Last Update Posted: 2013-12-27
• Primary Completion: 2015-12
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Repeated GnRHa	triptorelin	Patients were triggered with repeated GnRHa

Primary Outcome Measures

Name	Time	Method
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 retrieval day (34 to 38 hours post the first trigger with GnRHa)	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 maturity	24 hours post oocyte retrieval day	Oocyte maturity was defined as the ratio of metaphase II (MII) oocytes to the number of collected oocytes in the patients undergoing with ICSI.

Secondary Outcome Measures

Name	Time	Method
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	48 hours post IVF/ICSI	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).
implantation rate	1 month post embryo transfer

Trial Locations

Locations (1)

Center for Reproductive Medicine, Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China