Dual Trigger to Reduce Ovarian Hyperstimulation Syndrome

Not Applicable

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

• Registration Number: NCT02022228
• 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Status Verified: 2013-10
• 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: 200

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: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.2mg triptorelin and 500 IU hCG	triptorelin	Patients were triggered with 0.2mg triptorelin and 500 IU hCG
0.2mg triptorelin and 500 IU hCG	hCG	Patients were triggered with 0.2mg triptorelin and 500 IU hCG
0.2mg triptorelin and 1000 IU hCG	triptorelin	Patients were triggered with 0.2mg triptorelin and 1000 IU hCG
0.2mg triptorelin and 1000 IU hCG	hCG	Patients were triggered with 0.2mg triptorelin and 1000 IU hCG

Primary Outcome Measures

Name	Time	Method
numbers of patients having OHSS	2 weeks post trigger with dual GnRHa
clinical pregnancy rate per transfer cycle	1month post embryo transfer
oocyte yield	oocyte retrieval day (34 to 38 hours post trigger with GnRHa and hCG)	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 intracytoplasmic sperm injection (ICSI).

Secondary Outcome Measures

Name	Time	Method
serum hCG level 12 hours post trigger	12 hours post trigger
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
serum luteinizing hormone level 12 hours post trigger	12 hours post trigger

Trial Locations

Locations (1)

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