Phase 2
Completed N=198
Cavitation Ultrasound in Treatment of Patients With PCOS
Source: ClinicalTrials.gov NCT01622257 ↗Enrolled (actual)
198
Serious AEs
0.0%
Results posted
Feb 2013
Primary outcomePrimary: Clinical Pregnancy Rate — 12; 5; 16 participants
Summary
The aim of the current work was to compare the efficacy of cavitation ultrasound, metformin or combination of both in obese women with polycystic ovary syndrome (PCOS) regarding clinical pregnancy rate, ovulation rate, insulin resistance, serum testosterone level, lipid profile.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Pregnancy Rate |
12; 5; 16 | — |
| SECONDARY Ovulation Rate as Determined by Ultrasonographic Folliculometry and Luteal Serum Progesterone Assay. |
39; 16; 45 | — |
| SECONDARY Change in Insulin Resistance |
-2.4; -1.1; -3.4 | — |
| SECONDARY Change in Serum Free Testosterone Level |
-0.4; -0.2; -0.6 | — |
| SECONDARY Change in Lipid Profile |
-10.2; -8.9; -20.9 | — |
Eligibility Criteria
Inclusion Criteria
- Obese infertile polycystic ovarian syndrome (PCOS) women
Exclusion Criteria
- Women 40 years or older
- Women using fertility treatments, oral contraceptives or other confounding medications during the last 3 months
- Smokers or with history of general diseases like cardiovascular, liver, kidney or respiratory disease, diabetes, uncontrolled hypertension, or malignancy
Data sourced from ClinicalTrials.gov (NCT01622257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.