Results of using laparoscopic (keyhole) surgery to remove large fibroids (noncancerous growth of muscle tissue in the uterus) with temporary clamping of the uterine blood vessels compared to other surgical methods

Not Applicable

Completed

• Conditions: Improve treatment outcomes for women with infertility associated with uterine fibroids; Urological and Genital Diseases

• Registration Number: ISRCTN13841888
• Lead Sponsor: Institute of Reproductive Medicine Almaty

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-10-01
• Study Start: 2023-01-25
• Last Update Posted: 6 February 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

1. Age from 25 to 30 years;
2. Presence of one 4–6 cm myoma nodule according to expert ultrasound;
3. Anti-Mullerian hormone (AMH) level not less than 2 ng/ml;
4. Confirmed patency of both uterine tubes;
5. Confirmed absence of other forms of infertility;
6. Primary infertility;
7. Patients planning spontaneous pregnancy

Exclusion Criteria

1. Acute or chronic inflammatory and infectious diseases during exacerbation;
2. Malignant neoplasms;
3. Benign neoplasms of the ovaries and/or uterus;
4. Hemorrhoids of stage 3 or 4;
5. Uncompensated chronic somatic diseases;
6. Thromboses;
7. Hemoglobin level of less than 100 g/l for groups 1;2;4; for group 3 it is less than 90 g/l;
8. Non-compliance with the inclusion criteria.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Hemoglobin level is measured using general blood analysis at the initial visit, before and after the operation.<br> 2. Blood loss is measured using blood control system during the operation.<br> 3. Intrauterine pathology is measured using hysteroscopy 3 months after the operation.<br>

Secondary Outcome Measures

Name	Time	Method
Diagnostic hysteroscopy was performed 3 months after the operation and every 6 months after hysteroscopic control for 2 years. The questions concerned only the following: the onset of spontaneous pregnancy, gestational age and outcome of pregnancy.