Trial · NCT01622257
Cavitation Ultrasound in Treatment of Patients With PCOS
NCT01622257, Phase 2, Completed, Ain Shams University; results first posted 2013-02-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Cavitation Ultrasound in Treatment of Patients With PCOS. Trials, record NCT01622257. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01622257
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Cavitation Ultrasound in Treatment of Patients With PCOS
- NCT number
- NCT01622257
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 198 participants, actual
- Lead sponsor
- Ain Shams University
- Conditions
- PCOS
- Interventions
- Cavitation US, Metformin, Cavitation US + Metformin
- First posted
- 2012-06-19
- Last updated
- 2017-04-07
- Results first posted
- 2013-02-07
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Pregnancy Rate | 9 months | |
| Secondary | Ovulation Rate as Determined by Ultrasonographic Folliculometry and Luteal Serum Progesterone Assay. | 3 months | The Number of participants who had evidence of successful ovulation during the 3 months. Ovulation was diagnosed based on ultrasonographic folliculometry and/or luteal serum progesterone assay.Every month, folliculometry was done to count the number of antral follicles (AFC), follow follicular growth, measure dominant follicle diameter and detect occurrence of ovulation. a mid-luteal serum progesterone assay was done to confirm ovulation. Ultrasound was performed serially till reaching preovulatory follicle(s of around 20 mm in diameter that then rupture to show a collapsed follicle in the same location with internal echoes consistent with its transformation to a corpus luteum. Progesterone assay was done using immulite 2000 apparatus chemiluminescent immunometric assay. Mid-luteal phase progesterone above 6 ng/mL was considered indicative of normal corpus. luteum function. |
| Secondary | Change in Insulin Resistance | Baseline and 3 months | Change in Fasting insulin concentration |
| Secondary | Change in Serum Free Testosterone Level | Baseline and 3 months | Change in serum free testosterone levels |
| Secondary | Change in Lipid Profile | Baseline and 3 months | Change in LDL levels was taken as the indicator of change in lipid profile |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Pregnancy Rate | 9 months | participants | NUMBER | |
| SECONDARY | Ovulation Rate as Determined by Ultrasonographic Folliculometry and Luteal Serum Progesterone Assay. | 3 months | participants | NUMBER | |
| SECONDARY | Change in Insulin Resistance | Baseline and 3 months | uIU/ml | MEAN | |
| SECONDARY | Change in Serum Free Testosterone Level | Baseline and 3 months | pg/ml | MEAN | |
| SECONDARY | Change in Lipid Profile | Baseline and 3 months | mg/dl | MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Pregnancy Rate | Cavitation US | 12 | participants | ||
| Clinical Pregnancy Rate | Metformin | 5 | participants | ||
| Clinical Pregnancy Rate | Cavitation US + Metformin | 16 | participants | ||
| Ovulation Rate as Determined by Ultrasonographic Folliculometry and Luteal Serum Progesterone Assay. | Cavitation US | 39 | participants | ||
| Ovulation Rate as Determined by Ultrasonographic Folliculometry and Luteal Serum Progesterone Assay. | Metformin | 16 | participants | ||
| Ovulation Rate as Determined by Ultrasonographic Folliculometry and Luteal Serum Progesterone Assay. | Cavitation US + Metformin | 45 | participants | ||
| Change in Insulin Resistance | Cavitation US | -2.4 | 95% Confidence Interval -2.61 to -2.1 | uIU/ml | |
| Change in Insulin Resistance | Metformin | -1.1 | 95% Confidence Interval -1.21 to -0.9 | uIU/ml | |
| Change in Insulin Resistance | Cavitation US + Metformin | -3.4 | 95% Confidence Interval -3.74 to -3.0 | uIU/ml | |
| Change in Serum Free Testosterone Level | Cavitation US | -0.4 | 95% Confidence Interval -0.44 to -0.36 | pg/ml |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cavitation US | 66 | |
| Overall Study | STARTED | Metformin | 66 | |
| Overall Study | STARTED | Cavitation US + Metformin | 66 | |
| Overall Study | COMPLETED | Cavitation US | 66 | |
| Overall Study | COMPLETED | Metformin | 66 | |
| Overall Study | COMPLETED | Cavitation US + Metformin | 66 | |
| Overall Study | NOT COMPLETED | Cavitation US | 0 | |
| Overall Study | NOT COMPLETED | Metformin | 0 | |
| Overall Study | NOT COMPLETED | Cavitation US + Metformin | 0 |
Source ClinicalTrials.gov
Adverse events9
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gastrointestinal upset | Gastrointestinal disorders | Cavitation US | 0 | 66 | 0 |
| other | Gastrointestinal upset | Gastrointestinal disorders | Metformin | 11 | 66 | 34 |
| other | Gastrointestinal upset | Gastrointestinal disorders | Cavitation US + Metformin | 9 | 66 | 31 |
| other | Generalized malaise | Musculoskeletal and connective tissue disorders | Cavitation US | 0 | 66 | 0 |
| other | Generalized malaise | Musculoskeletal and connective tissue disorders | Metformin | 4 | 66 | 19 |
| other | Generalized malaise | Musculoskeletal and connective tissue disorders | Cavitation US + Metformin | 3 | 66 | 17 |
| other | Localized reaction | Skin and subcutaneous tissue disorders | Cavitation US | 9 | 66 | 19 |
| other | Localized reaction | Skin and subcutaneous tissue disorders | Metformin | 0 | 66 | 0 |
| other | Localized reaction | Skin and subcutaneous tissue disorders | Cavitation US + Metformin | 7 | 66 | 23 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cavitation US | ||
| Total, all-cause mortality | Metformin | ||
| Total, all-cause mortality | Cavitation US + Metformin | ||
| Total, other adverse events | Cavitation US | 9 | 66 |
| Total, other adverse events | Metformin | 15 | 66 |
| Total, other adverse events | Cavitation US + Metformin | 19 | 66 |
| Total, serious adverse events | Cavitation US | 0 | 66 |
| Total, serious adverse events | Metformin | 0 | 66 |
| Total, serious adverse events | Cavitation US + Metformin | 0 | 66 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01622257
GET https://conductscience.org/api/trials/v1/NCT01622257/registered