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Repeated Injection of GnRH Agonist to Reduce Ovarian Hyperstimulation Syndrome

Primary Purpose

Infertility and at High Risk of OHSS

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
triptorelin
Sponsored by
Chenshiling
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility and at High Risk of OHSS focused on measuring Ovarian Hyperstimulation Syndrome, Luteinizing Hormone, Polycystic Ovarian Syndrome, Ovarian Yield, Ovarian Maturity

Eligibility Criteria

undefined - 40 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Center for Reproductive Medicine, Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Repeated GnRHa

Arm Description

Patients were triggered with repeated GnRHa

Outcomes

Primary Outcome Measures

clinical pregnancy rate per transfer cycle
numbers of patients having OHSS
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 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.

Secondary Outcome Measures

serum luteinizing hormone level 12 hours post first trigger
serum luteinizing hormone level 24 hours post first 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).
implantation rate

Full Information

First Posted
December 15, 2013
Last Updated
December 20, 2013
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
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1. Study Identification

Unique Protocol Identification Number
NCT02022241
Brief Title
Repeated Injection of GnRH Agonist to Reduce Ovarian Hyperstimulation Syndrome
Official Title
Repeated Injection of GnRH Agonist for Triggering Final Oocyte Maturation in Patients at High Risk of Ovarian Hyperstimulation Syndrome in GnRH Antagonist Protocol
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the 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

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility and at High Risk of OHSS
Keywords
Ovarian Hyperstimulation Syndrome, Luteinizing Hormone, Polycystic Ovarian Syndrome, Ovarian Yield, Ovarian Maturity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Repeated GnRHa
Arm Type
Experimental
Arm Description
Patients were triggered with repeated GnRHa
Intervention Type
Drug
Intervention Name(s)
triptorelin
Other Intervention Name(s)
Diphereline
Intervention Description
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.
Primary Outcome Measure Information:
Title
clinical pregnancy rate per transfer cycle
Time Frame
1month post embryo transfer
Title
numbers of patients having OHSS
Time Frame
2 weeks post trigger with repeated GnRHa
Title
oocyte yield
Description
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.
Time Frame
oocyte retrieval day (34 to 38 hours post the first trigger with GnRHa)
Title
Oocyte maturity
Description
Oocyte maturity was defined as the ratio of metaphase II (MII) oocytes to the number of collected oocytes in the patients undergoing with ICSI.
Time Frame
24 hours post oocyte retrieval day
Secondary Outcome Measure Information:
Title
serum luteinizing hormone level 12 hours post first trigger
Time Frame
12 hours post trigger with the first injection of GnRHa
Title
serum luteinizing hormone level 24 hours post first trigger
Time Frame
24 hours post the first injection of GnRHa
Title
fertilization rate
Description
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).
Time Frame
48 hours post IVF/ICSI
Title
implantation rate
Time Frame
1 month post embryo transfer

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shi-Ling Chen, M.D., Ph.D.
Phone
+86-20-62787604
Email
chensl_92@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shi-Ling Chen, M.D., Ph.D.
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Xin Chen, M.D., Ph.D.
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Center for Reproductive Medicine, Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shi-Ling Chen, M.D., Ph.D.
Phone
+86-20-62787604
Email
chensl_92@163.com
First Name & Middle Initial & Last Name & Degree
Shi-Ling Chen, M.D., Ph.D.

12. IPD Sharing Statement

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Repeated Injection of GnRH Agonist to Reduce Ovarian Hyperstimulation Syndrome

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