NCT00844350

Brief Summary

The specific aims of this study were to assess whether letrozole as an aromatase inhibitor plus hCG or OT alone, or in combination compared with CC, improves ovarian response.Ethical design of this study is based on the ethical guidelines of the Iranian Medical and Health Ministry which is accepted by Tabriz medical university ethical committee .

Trial Health

100
On Track

Trial Health Score

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

Enrollment
177

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_2

Status
completed

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

October 1, 2006

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 16, 2009

Completed
Last Updated

February 16, 2009

Status Verified

February 1, 2009

Enrollment Period

11 months

First QC Date

February 13, 2009

Last Update Submit

February 13, 2009

Conditions

Ovarian Response

Keywords

OxytocinLetrozoleInduction of ovulation

Outcome Measures

Primary Outcomes (1)

  • number of follicles, endometrial thickness, and clinical pregnancy rate

    first ,second and third month

Study Arms (5)

letrozole+hCG

NO INTERVENTION
Drug: letrozole , oxytocin,hCG,clomiphene citrate

letrozole+oxytocin

NO INTERVENTION
Drug: letrozole , oxytocin,hCG,clomiphene citrate

letrozole+oxytocin+hCG

NO INTERVENTION
Drug: letrozole , oxytocin,hCG,clomiphene citrate

clomiphene citrate +oxytocin

NO INTERVENTION
Drug: letrozole , oxytocin,hCG,clomiphene citrate

clomiphene citrate +oxytocin+hCG

NO INTERVENTION
Drug: letrozole , oxytocin,hCG,clomiphene citrate

Interventions

letrozole , oxytocin,hCG,clomiphene citrateDRUG
clomiphene citrate +oxytocinclomiphene citrate +oxytocin+hCGletrozole+hCGletrozole+oxytocinletrozole+oxytocin+hCG

Eligibility Criteria

Age17 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • infertile women who had chronic anovulation
  • classical PCOS with CC+hCG failure
  • age \<40 y
  • had patent tubes on hysterosalpingography
  • no other pelvic pathology
  • participated in this study

You may not qualify if:

  • hypersensitivity to any oxytocic medications
  • history of cardiovascular disease
  • took anti-hypertensive medications were excluded.
  • women with blood pressure less than 90/60 mmHg
  • abnormal spermogram
  • anxiety
  • excess prolactin levels
  • other causes of infertility were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Letrozole

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 13, 2009

First Posted

February 16, 2009

Study Start

October 1, 2006

Primary Completion

September 1, 2007

Study Completion

October 1, 2007

Last Updated

February 16, 2009

Record last verified: 2009-02