Trials / Terminated
TerminatedNCT03571776
Anti-mullerian Hormone (AMH) After Treatment of Endometriomas With Alcohol Sclerotherapy Versus Surgery: Clinical Trial
Anti-mullerian Hormone in Ovarian Reserve Evaluation After Treatment of Endometriomas With Alcohol Sclerotherapy Versus Surgery: Clinical Trial
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 158 (actual)
- Sponsor
- Hospital Universitari de Bellvitge · Academic / Other
- Sex
- Female
- Age
- 18 Years – 45 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this multicenter study is to compare the ovarian reserve after alcohol sclerosis of the endometriomas against conventional surgery (AMH, follicle stimulating hormone (FSH) and antral follicles count) as well as the complications and costs between the 2 procedures.
Detailed description
Clinical Trial Phase III, Multicenter, National, open, parallel-group assignment 1: 1, stratified by age, previous oophorectomy and uni- or bilateral ovarian involvement. Patients with suspected ovarian endometrioma by ultrasound will be randomized into 2 groups: (a) Study Group: echoguided aspiration plus sclerosis with alcohol; (B) Control group: Laparoscopic Cystectomy. Pre-treatment, and 6 months after treatment, AMH values will be determined. Complications, recurrences and costs from each treatment will be collected.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Surgery | Laparoscopic ovarian cystectomy |
| PROCEDURE | Sclerotherapy | US-aspiration and alcohol sclerosis |
Timeline
- Start date
- 2018-06-05
- Primary completion
- 2023-01-15
- Completion
- 2023-01-15
- First posted
- 2018-06-28
- Last updated
- 2023-03-02
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT03571776. Inclusion in this directory is not an endorsement.