NCT00239603

Brief Summary

The purpose of this study is to evaluate the effectiveness of the OV-Watch to predict ovulation while women are taking clomiphene citrate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2005

Geographic Reach
1 country

1 active site

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, 2005

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

April 17, 2007

Status Verified

April 1, 2007

First QC Date

October 13, 2005

Last Update Submit

April 16, 2007

Conditions

InfertilityAnovulationPolycystic Ovary Syndrome

Keywords

OV-Watchfertility monitorovulation inductionclomiphene citrateanovulationinfertility

Interventions

OV-WatchDEVICE

Eligibility Criteria

Age21 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients eligible to participate must be between the age of 21 and 42.
  • Patient must demonstrate ability to follow standard clomiphene citrate ovulation induction protocol and wear the OV-Watch™ correctly.
  • Intact uterus and at least one ovary must be present.
  • Patients must be diagnosed with anovulation (lack of ovulation) that is not caused by hypothalamic amenorrhea or premature ovarian failure.
  • A hysterosalpingogram must be performed to demonstrate at least one patent fallopian tube. The uterine cavity must also appear normal on this study.
  • The male partner or sperm donor must demonstrate an acceptable concentration and motility of sperm.

You may not qualify if:

  • or more previous treatment cycles using clomiphene citrate.
  • Any condition where the use of clomiphene is contraindicated, such as breast cancer or liver disease.
  • Any other hormonal disease that may be secondarily causing anovulation, such as thyroid disorder or hyperprolactinemia.
  • Amenorrhea caused by premature ovarian failure or hypothalamic amenorrhea.
  • Any active genital tract infection will need to be treated with antibiotics before undergoing ovulation induction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory Reproductive Center, Crawford Long Hospital

Atlanta, Georgia, 30308, United States

Location

MeSH Terms

Conditions

InfertilityAnovulationPolycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • Celia E Dominguez, MD

    Emory Reproductive Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 13, 2005

First Posted

October 17, 2005

Study Start

October 1, 2005

Study Completion

June 1, 2007

Last Updated

April 17, 2007

Record last verified: 2007-04

Locations

US(1)