NCT00894608

Brief Summary

The purpose of this study is to determine whether letrozole combined with gonadotropins are effective in the ovarian hyperstimulating for IVF/ICSI in patients with PCOS.

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
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 5, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

May 7, 2009

Status Verified

May 1, 2009

Enrollment Period

1.9 years

First QC Date

May 5, 2009

Last Update Submit

May 5, 2009

Conditions

Polycystic Ovarian Syndrome

Keywords

letrozoleovarian stimulationPCOSIVF-ET

Outcome Measures

Primary Outcomes (1)

  • Cycle cancellation rate, number of oocytes retrieved, fertilization rate, embryo quality, clinical pregnancy, implantation rates and OHSS rate

    2 years

Study Arms (2)

letrozole protocol

EXPERIMENTAL

patients in letrozole protocol for ovarian stimulation with letrozole combined with gonadotropins

Drug: letrozole + gonadotropins

long GnRHa protocol

EXPERIMENTAL

patients in long GnRHa protocol for ovarian stimulation with Gnrha and gonadotropins

Drug: GnRHa + gonadotropins

Interventions

letrozole + gonadotropinsDRUG

patients in letrozole protocol for ovarian stimulation with letrozole combined with gonadotropins

letrozole protocol
GnRHa + gonadotropinsDRUG

patients in long GnRHa protocol for ovarian stimulation with GnRHa and gonadotropins

long GnRHa protocol

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with PCOS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Medcine Research Center

Shiyan, Hubei, 442000, China

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

LetrozoleGonadotropins

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • zhang changjun, doctor

    renmin hospital,yunyang medical college

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 5, 2009

First Posted

May 7, 2009

Study Start

January 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

May 7, 2009

Record last verified: 2009-05

Locations

CN(1)