NCT02022228

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 27, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

December 27, 2013

Status Verified

October 1, 2013

Enrollment Period

3.4 years

First QC Date

December 15, 2013

Last Update Submit

December 20, 2013

Conditions

Infertility and at High Risk of OHSS

Keywords

Ovarian Hyperstimulation SyndromeLuteinizing HormonePolycystic Ovarian SyndromeOvarian YieldOvarian MaturityGonadotropin Releasing Hormone AgonistHuman Chorionic Gonadotropin

Outcome Measures

Primary Outcomes (4)

  • clinical pregnancy rate per transfer cycle

    1month post embryo transfer

  • numbers of patients having OHSS

    2 weeks post trigger with dual 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 trigger with GnRHa and hCG)

  • 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).

    24 hours post oocyte retrieval day

Secondary Outcomes (4)

  • serum luteinizing hormone level 12 hours post trigger

    12 hours post trigger

  • serum hCG level 12 hours post trigger

    12 hours post trigger

  • fertilization rate

    48 hours post IVF/ICSI

  • implantation rate

    1 month post embryo transfer

Study Arms (2)

0.2mg triptorelin and 500 IU hCG

EXPERIMENTAL

Patients were triggered with 0.2mg triptorelin and 500 IU hCG

Drug: triptorelinDrug: hCG

0.2mg triptorelin and 1000 IU hCG

EXPERIMENTAL

Patients were triggered with 0.2mg triptorelin and 1000 IU hCG

Drug: triptorelinDrug: hCG

Interventions

triptorelinDRUG

0.2 mg triptorelin, ih

Also known as: triptorelin: Diphereline
0.2mg triptorelin and 1000 IU hCG0.2mg triptorelin and 500 IU hCG
hCGDRUG

1000 IU hCG, im

0.2mg triptorelin and 1000 IU hCG

Eligibility Criteria

AgeUp to 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • patients undergoing coasting
  • patients with past ovarian surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Guangzhou, Guangdong, 510515, China

RECRUITING

MeSH Terms

Conditions

InfertilityOvarian Hyperstimulation SyndromePolycystic Ovary Syndrome

Interventions

Triptorelin Pamoate

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGonadal DisordersEndocrine System DiseasesOvarian CystsCystsNeoplasms

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing HormonePituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • Shi-Ling Chen, M.D., Ph.D.

    Nanfang Hospital, Southern Medical University

    STUDY CHAIR

Central Study Contacts

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

CONTACT

+86-20-62787604chensl_92@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, M.D., Ph.D.

Study Record Dates

First Submitted

December 15, 2013

First Posted

December 27, 2013

Study Start

July 1, 2012

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

December 27, 2013

Record last verified: 2013-10

Locations

CN(1)