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Dual Trigger 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

hCG

About this trial

This is an interventional prevention trial for Infertility and at High Risk of OHSS focused on measuring Ovarian Hyperstimulation Syndrome, Luteinizing Hormone, Polycystic Ovarian Syndrome, Ovarian Yield, Ovarian Maturity, Gonadotropin Releasing Hormone Agonist, Human Chorionic Gonadotropin

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 2

Arm Type

Experimental

Arm Label

0.2mg triptorelin and 500 IU hCG

0.2mg triptorelin and 1000 IU hCG

Arm Description

Patients were triggered with 0.2mg triptorelin and 500 IU hCG

Patients were triggered with 0.2mg triptorelin and 1000 IU hCG

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 intracytoplasmic sperm injection (ICSI).

Secondary Outcome Measures

serum luteinizing hormone level 12 hours post trigger

serum hCG level 12 hours post 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

NCT ID

NCT02022228

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

1. Study Identification

Unique Protocol Identification Number

NCT02022228

Brief Title

Dual Trigger to Reduce Ovarian Hyperstimulation Syndrome

Official Title

Dual Trigger With GnRH Agonist and Human Chorionic Gonadotropin for 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

October 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

4. Oversight

Data Monitoring Committee

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 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.

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, Gonadotropin Releasing Hormone Agonist, Human Chorionic Gonadotropin

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

0.2mg triptorelin and 500 IU hCG

Arm Type

Experimental

Arm Description

Patients were triggered with 0.2mg triptorelin and 500 IU hCG

Arm Title

0.2mg triptorelin and 1000 IU hCG

Arm Type

Experimental

Arm Description

Patients were triggered with 0.2mg triptorelin and 1000 IU hCG

Intervention Type

Drug

Intervention Name(s)

triptorelin

Other Intervention Name(s)

triptorelin: Diphereline

Intervention Description

0.2 mg triptorelin, ih

Intervention Type

Drug

Intervention Name(s)

hCG

Intervention Description

1000 IU hCG, im

Intervention Type

Drug

Intervention Name(s)

hCG

Intervention Description

500IU hCG, im

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 dual 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 trigger with GnRHa and hCG)

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 intracytoplasmic sperm injection (ICSI).

Time Frame

24 hours post oocyte retrieval day

Secondary Outcome Measure Information:

Title

serum luteinizing hormone level 12 hours post trigger

Time Frame

12 hours post trigger

Title

serum hCG level 12 hours post trigger

Time Frame

12 hours post trigger

Title

fertilization rate

Description

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

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

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

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

chensl_92@163.com

First Name & Middle Initial & Last Name & Degree

Shi-Ling Chen, M.D., Ph.D.

12. IPD Sharing Statement

Learn more about this trial

Dual Trigger to Reduce Ovarian Hyperstimulation Syndrome

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