InfertilityNCT00239603
Efficacy Study of the OV-Watch™ Personal Fertility Monitor for Women Using Clomiphene Citrate.
An observational study of Infertility and Anovulation, run by Emory University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of the OV-Watch to predict ovulation while women are taking clomiphene citrate. Read more about this study
- Who is it for?
- Ages 21 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Anovulation, Polycystic Ovary Syndrome
- What is being tested?
- OV-Watch
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Jun 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 12 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Emory Reproductive Center, Crawford Long Hospital
Atlanta, Georgia, 30308
About this study
Official title: Clinical Investigation of the OV-Watch™ Personal Fertility Monitor for Women Undergoing Ovulation Induction With Clomiphene Citrate.
The purpose of this study is to evaluate the effectiveness of the OV-Watch to predict ovulation while women are taking clomiphene citrate.
Read the detailed description
At any given time, there are 10-15% of American couples with infertility. A problem with ovulation (releasing an egg) is one of the most common causes of female infertility. The frequency and timing of intercourse is important because the best chance of pregnancy occurs around the time of ovulation. The days that pregnancy is most likely to occur with intercourse is referred to as the "fertile window".
The fertile window lasts for 6 days. It starts 4 days before ovulation and continues through the day after ovulation. Intercourse on the day of ovulation gives the highest chance of getting pregnant. However, intercourse up to 4 days before ovulation can still result in pregnancy because sperm can survive for up to 6 days in the reproductive tract of a woman.
Urinary testing for the luteinizing hormone (LH) surge is the most common method for predicting ovulation. The LH surge precedes ovulation by about 36 hours. When LH is detected, this gives a couple only 2 days to have intercourse that may result in fertilization.
The OV-Watch is an FDA approved device that has been shown to predict ovulation 5 days in advance for women who ovulate regularly. This wristwatch-like device is worn daily to detects changes in sweat ions. The device allows for earlier detection of the fertile window, giving the couple more opportunities to conceive.
For women who do not ovulate on their own or ovulate irregularly, medication can be taken to help make eggs and ovulate. Clomiphene citrate is the most commonly used medication for this. We plan to study the effectiveness of the OV-Watch in women who are undergoing ovulation induction with clomiphene citrate and will compare the results to standard urinary LH testing.
- Conditions
- Infertility, Anovulation, Polycystic Ovary Syndrome
- Being tested
- OV-Watch
- Keywords
- OV-Watch, fertility monitor, ovulation induction, clomiphene citrate, anovulation, infertility
- Medical subject headings
- Infertility, Anovulation, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OV-WatchDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2005 (estimated)
- Study startOct 2005
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- HealthWatchSystems, Inc.
- Investigators
- Celia E Dominguez, MD, Principal investigator, Emory Reproductive Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00239603
- Sponsor's protocol ID
- 867-2005
- Status last verified
- Apr 2007
- First submitted
- 13 Oct 2005
- Last updated
- 17 Apr 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the OV-Watch™ Personal Fertility Monitor for Women Undergoing Ovulation Induction With Clomiphene Citrate.
- ClinicalTrials.gov ID
- NCT00239603
- Acronym / sponsor ID
- 867-2005
- Conditions
- Infertility, Anovulation, Polycystic Ovary Syndrome
- Keywords
- OV-Watch, fertility monitor, ovulation induction, clomiphene citrate, anovulation, infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- HealthWatchSystems, Inc.
- Study start
- Oct 2005
- Study completion
- Jun 2007
- First posted
- 17 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effectiveness of the OV-Watch to predict ovulation while women are taking clomiphene citrate.
Detailed description
At any given time, there are 10-15% of American couples with infertility. A problem with ovulation (releasing an egg) is one of the most common causes of female infertility. The frequency and timing of intercourse is important because the best chance of pregnancy occurs around the time of ovulation. The days that pregnancy is most likely to occur with intercourse is referred to as the "fertile window".
The fertile window lasts for 6 days. It starts 4 days before ovulation and continues through the day after ovulation. Intercourse on the day of ovulation gives the highest chance of getting pregnant. However, intercourse up to 4 days before ovulation can still result in pregnancy because sperm can survive for up to 6 days in the reproductive tract of a woman.
Urinary testing for the luteinizing hormone (LH) surge is the most common method for predicting ovulation. The LH surge precedes ovulation by about 36 hours. When LH is detected, this gives a couple only 2 days to have intercourse that may result in fertilization.
The OV-Watch is an FDA approved device that has been shown to predict ovulation 5 days in advance for women who ovulate regularly. This wristwatch-like device is worn daily to detects changes in sweat ions. The device allows for earlier detection of the fertile window, giving the couple more opportunities to conceive.
For women who do not ovulate on their own or ovulate irregularly, medication can be taken to help make eggs and ovulate. Clomiphene citrate is the most commonly used medication for this. We plan to study the effectiveness of the OV-Watch in women who are undergoing ovulation induction with clomiphene citrate and will compare the results to standard urinary LH testing.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 12 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OV-Watch | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Celia E Dominguez, MD principal investigator
Emory Reproductive Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Anovulation, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2007.