NCT02477566

Brief Summary

To test whether long-acting Triptorelin on pituitary down-regulation can improve the clinical pregnancy rate and reduces the incidence of ovarian hyperstimulation syndrome (OHSS) in infertile high-risk patients with polycystic ovaries (PCOs) who underwent in vitro fertilization (IVF) or Intracytoplasmic sperm injection

Trial Health

55
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Trial Health Score

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

Enrollment
200

participants targeted

Target at 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

December 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Last Updated

June 23, 2015

Status Verified

June 1, 2015

Enrollment Period

2 years

First QC Date

June 17, 2015

Last Update Submit

June 22, 2015

Conditions

In Vitro FertilizationPolycystic Ovary Syndrome

Keywords

pcosLong acting TriptorelinShort acting TriptorelinIn Vitro Fertilization

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    compare the cinical pregnancy rate between long-acting and short-acting Triptorelin on pituitary down-regulation in PCOS patients who underwent IVF/ICSI treatment

    2 years

Secondary Outcomes (1)

  • moderate/severe OHSS rate

    2 years

Study Arms (2)

Long-acting Triptorelin

EXPERIMENTAL

Pituitary down-regulation with Long-acting Triptorelin 1.875mg during the luteal

Drug: Long-acting Triptorelin

Short-acting Triptorelin

ACTIVE COMPARATOR

Pituitary down-regulation with Short-acting Triptorelin 0.1mg/d,x10d, then 0.05mg/d until E2\<40pg/ml in serum, was initiated during the luteal phase

Drug: Short-acting Triptorelin

Interventions

Long-acting TriptorelinDRUG

Pituitary down-regulation with Long-acting Triptorelin 1.875mg during the luteal phase

Also known as: Long-acting Triptorelin on pituitary down-regulation
Long-acting Triptorelin
Short-acting TriptorelinDRUG

Pituitary down-regulation with Short-acting Triptorelin 0.1mg/d,x10d, then 0.05mg/d until E2\<40pg/ml in serum, was initiated during the luteal phase

Also known as: Short-acting Triptorelin on pituitary down-regulation
Short-acting Triptorelin

Eligibility Criteria

Age22 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • PCOS patients diagnosis by Rotterdam Consensus on Diagnostic Criteria who underwent IVF/ICSI treatment

You may not qualify if:

  • Patients with poor ovarian reserve,
  • immunological disease,
  • endometriosis,
  • uterine abnormality,
  • endometrium thickness \< 8mm before embryo transfer,
  • fewer than two good-quality embryos available for transfer or patients with inadequate data for analysis were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Room of Reproductive Medicine, The Outpatient Building of Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Central Study Contacts

Jianjun Zhou, Doctor

CONTACT

86-25-83304616-70014zhou6jj@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reproductive Medicine Center, Drum Tower Hospital Affiliated to Nanjing University Medical College

Study Record Dates

First Submitted

June 17, 2015

First Posted

June 23, 2015

Study Start

December 1, 2014

Primary Completion

December 1, 2016

Last Updated

June 23, 2015

Record last verified: 2015-06

Locations

CN(1)