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The efficacy of alcohol injection in endometrioma

Phase 2
Conditions
endometriosis.
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N80.1
Registration Number
IRCT201108024339N4
Lead Sponsor
Yazd University of Medical Sciences
Brief Summary

Background: Endometriosis is a common hormone-dependent gynecologic disease with a high recurrence. Laparotomy or laparoscopy is the standard surgery for the large endometrioma. Also, sclerotherapy is basically used to treat different diseases one of which is endometrioma. Objective: The study was designed to assess the value of transvaginal ultrasound-guided ethanol sclerotherapy in patients with a recurrent endometrioma. Materials and Methods:In a randomized clinical trial, an interventional group of 20 patients underwent transvaginal ethanol sclerotherapy for recurrent ovarian endometrioma. The patients were followed up first after one and two weeks and then after one, two, and three months. If the patients had no endometrioma, they were treated with in vitro fertilization (IVF) (standard long protocol). A control group of 20 patients with endometrioma were enrolled for an IVF protocol. They had no treatment by ethanol sclerotherapy. IVF parameters, pregnancy rates, and implantation rates were compared in both groups. Results: The demographic data showed no difference between the two groups. The initial mean endometria size was 41.45±15.9 cm, the recurrence rate after 6 months was 4 (20%), FSH before and after sclerotherapy was 6.97±2.25 IU/L and 6.78±1.88 IU/L (p=0.343). The clinical pregnancy rate was 6 (33.3%) vs. 3 (15%), (p=0.616). The fertilization rate emerged 63.06% in study group vs. 60.38%, (p=0.57). The implantation rate turned out 12.9% in study group vs. 7.5%, (p=0.52). None of these results were significant. However, the data pointed to a better trend toward the ethanol sclerotherapy group. Conclusion:Ethanol sclerotherapy could be an effective strategy for the treatment of recurrent endometrioma especially before IVF.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
Female
Target Recruitment
40
Inclusion Criteria

Being at the age of 20 to 39 years
Past history of operation on endometrioma with recurrent unilateral endometrioma
Recurrent endometrioma more than 30 mm
FSH<10

Exclusion Criteria

liver or kidney or heart diseases
sever male factor infertility

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The size of endometrioma. Timepoint: One week ; one, two, three and six months after surgery. Method of measurement: sonography.
Secondary Outcome Measures
NameTimeMethod
Chemical pregnancy. Timepoint: 14 days after embryo transfer. Method of measurement: serum BHCG.;Fertilization rates. Timepoint: Three days after fertilization. Method of measurement: The total number of embryos created is divided by the number of second metaphase oocytes multiplied by 100.;Implantation rates. Timepoint: Five weeks after transfer. Method of measurement: The number of gestational sacs divided by the number of transferred embryos multiplied by 100.;Clinical pregnancy rate. Timepoint: 7 weeks after embryo transfer. Method of measurement: Fetal heart rate in ultra sonography.
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