Dual Trigger to Reduce Ovarian Hyperstimulation Syndrome

NCT ID: NCT02022228

Last Updated: 2013-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2016-06-30

Brief Summary

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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

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Conditions

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Infertility and at High Risk of OHSS

Keywords

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Ovarian Hyperstimulation Syndrome Luteinizing Hormone Polycystic Ovarian Syndrome Ovarian Yield Ovarian Maturity Gonadotropin Releasing Hormone Agonist Human Chorionic Gonadotropin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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0.2mg triptorelin and 500 IU hCG

Patients were triggered with 0.2mg triptorelin and 500 IU hCG

Group Type EXPERIMENTAL

triptorelin

Intervention Type DRUG

0.2 mg triptorelin, ih

hCG

Intervention Type DRUG

500IU hCG, im

0.2mg triptorelin and 1000 IU hCG

Patients were triggered with 0.2mg triptorelin and 1000 IU hCG

Group Type EXPERIMENTAL

triptorelin

Intervention Type DRUG

0.2 mg triptorelin, ih

hCG

Intervention Type DRUG

1000 IU hCG, im

Interventions

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triptorelin

0.2 mg triptorelin, ih

Intervention Type DRUG

hCG

1000 IU hCG, im

Intervention Type DRUG

hCG

500IU hCG, im

Intervention Type DRUG

Other Intervention Names

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triptorelin: Diphereline

Eligibility Criteria

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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
Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

Comprehensive Strategic Cooperation Project of Guangdong Province and Chinese Academy of Science

OTHER

Sponsor Role collaborator

Guangzhou Science and Technology Program key projects

OTHER

Sponsor Role collaborator

National Key Basic Research Development Plan of China

UNKNOWN

Sponsor Role collaborator

Chenshiling

OTHER

Sponsor Role lead

Responsible Party

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Chenshiling

Professor, M.D., Ph.D.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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

Role: STUDY_CHAIR

Nanfang Hospital, Southern Medical University

Locations

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

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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

Role: CONTACT

Phone: +86-20-62787604

Email: [email protected]

Facility Contacts

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

Role: primary

Other Identifiers

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Dual Trigger

Identifier Type: -

Identifier Source: org_study_id