Repeated Injection of GnRH Agonist to Reduce Ovarian Hyperstimulation Syndrome

Repeated Injection of GnRH Agonist for Triggering Final Oocyte Maturation in Patients at High Risk of Ovarian Hyperstimulation Syndrome in GnRH Antagonist Protocol

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.

Study Overview

• Status: Unknown
• Conditions: Infertility and at High Risk of OHSS
• Intervention / Treatment: Drug: triptorelin

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Center for Reproductive Medicine, Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 40 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Repeated GnRHa; Patients were triggered with repeated GnRHa	Drug: triptorelin; 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.; Other Names: Diphereline

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: Chenshiling
• Collaborators: National Natural Science Foundation of China; Comprehensive Strategic Cooperation Project of Guangdong Province and Chinese Academy of Science; Guangzhou Science and Technology Program key projects; National Key Basic Research Development Plan of China
• Investigators: Study Chair: Shi-Ling Chen, M.D., Ph.D., Nanfang Hospital of Southern Medical University; Study Director: Xin Chen, M.D., Ph.D., Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: December 15, 2013
• First Submitted That Met QC Criteria: December 20, 2013
• First Posted (Estimate): December 27, 2013

Study Record Updates

• Last Update Posted (Estimate): December 27, 2013
• Last Update Submitted That Met QC Criteria: December 20, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Polycystic Ovarian Syndrome; Luteinizing Hormone; Ovarian Hyperstimulation Syndrome; Ovarian Yield; Ovarian Maturity
• Additional Relevant MeSH Terms: Pathologic Processes; Endocrine System Diseases; Disease; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Syndrome; Infertility; Ovarian Hyperstimulation Syndrome; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Luteolytic Agents; Triptorelin Pamoate
• Other Study ID Numbers: Repeated GnRHa trigger