EndometriosisNCT00464139
Prevalence of Endometriosis in a Well Defined Group of Infertile Women
An observational study of Endometriosis and Infertility, run by University Hospital, Gasthuisberg at 1 site in Belgium.
Trial summary
At the Leuven University Fertility Centre (LUFC) of the Department of Obstetrics and Gynecology of the University Hospitals Leuven, Belgium, a retrospective epidemiological prevalence study based on an electronic search of patient files was performed to determine the prevalence of histologically proven endometriosis… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometriosis, Infertility
- What is being tested?
- Laparoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 221 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2007to Feb 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: The electronic files of all patients who consulted the LUFC since 2003 were searched to select women with at least 1 year of infertility, a regular cycle (variation 21 - 35 days), whose partner had normal sperm according to World Health Organization (WHO) criteria (n = 304). After exclusion of 83 (27,3%) patients with a previous laparoscopic diagnosis of endometriosis before referral to our centre, 221 (72,7%) infertile women were included in our study.
Who may be able to join
- all patients who consulted the LUFC since 2003
- with at least 1 year of infertility,
- a regular cycle (variation 21 - 35 days),
- whose partner had normal sperm according to World Health Organization (WHO) criteria.
Who cannot join
- a previous laparoscopic diagnosis of endometriosis before referral to our centre
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Prevalence of Endometriosis in Infertile Women With Normal Ovulation and Normospermic Partners
At the Leuven University Fertility Centre (LUFC) of the Department of Obstetrics and Gynecology of the University Hospitals Leuven, Belgium, a retrospective epidemiological prevalence study based on an electronic search of patient files was performed to determine the prevalence of histologically proven endometriosis in a subset of infertile women with a regular cycle (variation 21 - 35 days), a partner with normal sperm and no previous surgical diagnosis of endometriosis.
Read the detailed description
In this study, the electronic files of all patients who consulted the LUFC since 2003 were searched to select women with at least 1 year of infertility, a regular cycle (variation 21 - 35 days), whose partner had normal sperm according to World Health Organization (WHO) criteria (n = 304).
After exclusion of 83 (27,3%) patients with a previous laparoscopic diagnosis of endometriosis before referral to our centre, 221 (72,7%) infertile women were included in our study.
- Conditions
- Endometriosis, Infertility
- Being tested
- Laparoscopy
- Keywords
- endometriosis, prevalence, fertility, pain, ultrasound
- Medical subject headings
- Endometriosis, Infertility, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparoscopyProcedure or surgery
Also called diagnostic laparoscopy, CO2 laser operative laparoscpy
Laparoscopy
| Study group | Role | What they receive |
|---|---|---|
| 1 | The electronic files of all patients who consulted the LUFC since 2003 were searched to select women with at least 1 year of infertility, a regular cycle (variation 21 - 35 days), whose partner had normal sperm according to World Health Organization (WHO) criteria (n = 304).
After exclusion of 83 (27,3%) patients with a previous laparoscopic diagnosis of endometriosis before referral to our centre, 221 (72,7%) infertile women were included in our study. Receives: Procedure: Laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The diagnosis of endometriosis was made by the fertility surgeon of the LUFC.
Measured: 2003 - 2006
Secondary outcomes (1)
The diagnosis of endometriosis was always confirmed by histological examination.
Measured: 2003 - 2006
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2007 (estimated)
- Study startJan 2007
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Investigators
- Christel LC Meuleman, MD, Principal investigator, University Hospital Gasthuisberg, Leuven, BelgiumThomas D'Hooghe, MD, PhD, Study director, University Hospital Gasthuisberg, Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00464139
- Sponsor's protocol ID
- EC - 20/03/2007
- Status last verified
- Feb 2009
- First submitted
- 18 Apr 2007
- Last updated
- 20 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Prevalence of Endometriosis in Infertile Women With Normal Ovulation and Normospermic Partners
- ClinicalTrials.gov ID
- NCT00464139
- Acronym / sponsor ID
- EC - 20/03/2007
- Conditions
- Endometriosis, Infertility
- Keywords
- endometriosis, prevalence, fertility, pain, ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 20 Apr 2007 (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.
At the Leuven University Fertility Centre (LUFC) of the Department of Obstetrics and Gynecology of the University Hospitals Leuven, Belgium, a retrospective epidemiological prevalence study based on an electronic search of patient files was performed to determine the prevalence of histologically proven endometriosis in a subset of infertile women with a regular cycle (variation 21 - 35 days), a partner with normal sperm and no previous surgical diagnosis of endometriosis.
Detailed description
In this study, the electronic files of all patients who consulted the LUFC since 2003 were searched to select women with at least 1 year of infertility, a regular cycle (variation 21 - 35 days), whose partner had normal sperm according to World Health Organization (WHO) criteria (n = 304).
After exclusion of 83 (27,3%) patients with a previous laparoscopic diagnosis of endometriosis before referral to our centre, 221 (72,7%) infertile women were included in our study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: LaparoscopyThe electronic files of all patients who consulted the LUFC since 2003 were searched to select women with at least 1 year of infertility, a regular cycle (variation 21 - 35 days), whose partner had normal sperm according to World Health Organization (WHO) criteria (n = 304). After exclusion of 83 (27,3%) patients with a previous laparoscopic diagnosis of endometriosis before referral to our centre, 221 (72,7%) infertile women were included in our study. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The electronic files of all patients who consulted the LUFC since 2003 were searched to select women with at least 1 year of infertility, a regular cycle (variation 21 - 35 days), whose partner had normal sperm according to World Health Organization (WHO) criteria (n = 304). After exclusion of 83 (27,3%) patients with a previous laparoscopic diagnosis of endometriosis before referral to our centre, 221 (72,7%) infertile women were included in our study.
Key inclusion criteria (4 listed)
- all patients who consulted the LUFC since 2003
- with at least 1 year of infertility,
- a regular cycle (variation 21 - 35 days),
- whose partner had normal sperm according to World Health Organization (WHO) criteria.
Key exclusion criteria (1 listed)
- a previous laparoscopic diagnosis of endometriosis before referral to our centre
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 |
|---|---|---|
| LaparoscopyAlso: diagnostic laparoscopy, CO2 laser operative laparoscpyLaparoscopy | Procedure or surgery | 1 |
Primary outcome
The diagnosis of endometriosis was made by the fertility surgeon of the LUFC.
Time frame: 2003 - 2006
1 secondary outcome
The diagnosis of endometriosis was always confirmed by histological examination.
Time frame: 2003 - 2006
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 20 Feb 2009.
Related trials for Endometriosis
Not yet recruiting
Prevalence of Small Intestinal Bacterial Overgrowth (SIBO) in Women With Endometriosis
SIBO, Endometriosis
Recruiting
Endometriosis Transcriptomic Cell Atlas
Endometriosis, Infertility
Not yet recruiting
Psychotherapy in Patients With Endometriosis: Cognitive Behavioral Therapy Versus Acceptance and Commitment Therapy
Endometriosis, Adenomyosis
Not yet recruitingObservational study
Impact of a Diagnosis or Lack of a Diagnosis of Endometriosis Via a Saliva Test on Pain Catastrophizing, Quality of Life, Symptoms of Anxiety and Depression, and Treatment Adherence
Endometriosis
Not yet recruitingPhase 2
PRECISION-E2: Teverelix in Women With Endometriosis - Pharmacodynamics, Safety and Precision Medicine Correlates
Endometriosis Pelvic, Endometriosis Ovaries
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.
Christel LC Meuleman, MD principal investigator
University Hospital Gasthuisberg, Leuven, Belgium
Thomas D'Hooghe, MD, PhD study director
University Hospital Gasthuisberg, Leuven, Belgium
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 Endometriosis and Infertility, run by University Hospital, Gasthuisberg at 1 site in Belgium.
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 4 inclusion and 1 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 20 Feb 2009. 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 Belgium. 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.
What does the primary outcome measure?
The diagnosis of endometriosis was made by the fertility surgeon of the LUFC. (time frame: 2003 - 2006). It is what the study was designed to measure, not a finding.
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 20 Feb 2009.