Body WeightOB-PCONCT02694419
The Effect of Obesity on Endometrium in PCOS
An observational study of Body Weight and Polycystic Ovary Syndrome, run by Assiut University at 1 site in Egypt.
Trial summary
The effect of Polycystic Ovary Syndrome (PCOS) with or without obesity has received a few attentions. There is a lack of evidence to whether the BMI affects the endometrial blood flow, which is necessary for implantation. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Body Weight, Polycystic Ovary Syndrome
- What is being tested?
- Doppler evaluation
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2016to Apr 2017
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: 100 women were recruited from gynecology clinic of Women Health Hospital
Who may be able to join
- Women with PCOS are diagnosed according to Rotterdam criteria, (Rotterdam and ASRM-Sponsored, 2004)by the presence of two out of the following three: oligomenorrhea (absence of menses for 35-182 days) or amenorrhea (absence of menses for >182 days), signs or symptoms of hyperandrogenism (acne, hirsutism), US showing polycystic ovaries.
- Fertile women had regular menstruation, with at least one previous spontaneous pregnancy.
Who cannot join
- Women known to have hepatic or renal dysfunction, Diabetes mellitus, hypertension, or cardiovascular disease.
- If they have used induction of ovulation drugs for the last three months.
- If they have used hormonal contraception in the last three months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Body Weight on Endometrial Ultrasonographic Characteristics in Polycystic Ovary Syndrome Patients
The effect of Polycystic Ovary Syndrome (PCOS) with or without obesity has received a few attentions. There is a lack of evidence to whether the BMI affects the endometrial blood flow, which is necessary for implantation.
- Conditions
- Body Weight, Polycystic Ovary Syndrome
- Being tested
- Doppler evaluation
- Keywords
- endometrium
- Medical subject headings
- Body Weight, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doppler evaluationDevice
Endometrial volume, endometrial and subendometrial vascularity indices are measured by 3D power Doppler
| Study group | Role | What they receive |
|---|---|---|
| obese/PCO | Women with PCOS who are overweight\obese with BMI ≥ 25 kg/m2. Receives: Device: Doppler evaluation | |
| normal weight/PCO | Women with PCOS who are normal weight with BMI < 25 kg/m2. Receives: Device: Doppler evaluation | |
| Obese/fertile | Fertile regularly menstruating women with at least one previous spontaneous pregnancy who are overweight\obese with BMI ≥ 25 kg/m2. Receives: Device: Doppler evaluation | |
| normal weight/fertile | Fertile regularly menstruating women with at least one previous spontaneous pregnancy who are normal weight with BMI < 25 kg/m2. Receives: Device: Doppler evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the mean difference in Doppler indices (VI-FI-VFI)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body WeightStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abbas, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02694419
- Sponsor's protocol ID
- PCOS
- Acronym
- OB-PCO
- Status last verified
- Aug 2017
- First submitted
- 24 Feb 2016
- Last updated
- 11 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Body Weight on Endometrial Ultrasonographic Characteristics in Polycystic Ovary Syndrome Patients
- ClinicalTrials.gov ID
- NCT02694419
- Acronym / sponsor ID
- OB-PCO / PCOS
- Conditions
- Body Weight, Polycystic Ovary Syndrome
- Keywords
- endometrium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 29 Feb 2016 (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 effect of Polycystic Ovary Syndrome (PCOS) with or without obesity has received a few attentions. There is a lack of evidence to whether the BMI affects the endometrial blood flow, which is necessary for implantation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| obese/PCO | – | Device: Doppler evaluationWomen with PCOS who are overweight\obese with BMI ≥ 25 kg/m2. |
| normal weight/PCO | – | Device: Doppler evaluationWomen with PCOS who are normal weight with BMI < 25 kg/m2. |
| Obese/fertile | – | Device: Doppler evaluationFertile regularly menstruating women with at least one previous spontaneous pregnancy who are overweight\obese with BMI ≥ 25 kg/m2. |
| normal weight/fertile | – | Device: Doppler evaluationFertile regularly menstruating women with at least one previous spontaneous pregnancy who are normal weight with BMI < 25 kg/m2. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- 100 women were recruited from gynecology clinic of Women Health Hospital
Key inclusion criteria (2 listed)
- Women with PCOS are diagnosed according to Rotterdam criteria, (Rotterdam and ASRM-Sponsored, 2004)by the presence of two out of the following three: oligomenorrhea (absence of menses for 35-182 days) or amenorrhea (absence of menses for >182 days), signs or symptoms of hyperandrogenism (acne, hirsutism), US showing polycystic ovaries.
- Fertile women had regular menstruation, with at least one previous spontaneous pregnancy.
Key exclusion criteria (3 listed)
- Women known to have hepatic or renal dysfunction, Diabetes mellitus, hypertension, or cardiovascular disease.
- If they have used induction of ovulation drugs for the last three months.
- If they have used hormonal contraception in the last three months.
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 |
|---|---|---|
| Doppler evaluationEndometrial volume, endometrial and subendometrial vascularity indices are measured by 3D power Doppler | Device | Obese/fertile, normal weight/PCO, normal weight/fertile, obese/PCO |
Primary outcome
the mean difference in Doppler indices (VI-FI-VFI)
Time frame: 24 hours
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 11 Aug 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Body Weight and Polycystic Ovary Syndrome, run by Assiut University at 1 site in Egypt.
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 2 inclusion and 3 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 11 Aug 2017. 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 Egypt. 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 mean difference in Doppler indices (VI-FI-VFI) (time frame: 24 hours). 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 11 Aug 2017.