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

Comparison of reproductive and other outcomes in laparoscopic myomectomy with temporary cross-clamping of uterine arteries for submucosal large leiomyoma nodules with other surgical techniques

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN13841888

Enrollment

160

Registered

2023-01-25

Start date

2018-07-01

Completion date

Unknown

Last updated

2023-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Improve treatment outcomes for women with infertility associated with uterine fibroids Urological and Genital Diseases

Interventions

The authors randomized the participants into 4 groups. Each of the participants was given an envelope with the number of the group generated by a computer: 1. Laparotomy myomectomy

2. Laparoscopy without uterine artery cross-clamping

3. Laparoscopy with uterine artery cross-clamping

4. Resectoscopy myomectomy. The main researcher knew about the allocation of the study groups. Three months later, the scar was assessed and the condition of the uteri

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
1. Hemoglobin level is measured using general blood analysis at the initial visit, before and after the operation. 2. Blood loss is measured using blood control system during the operation. 3. Intrauterine pathology is measured using hysteroscopy 3 months after the operation.	—

Secondary

Measure	Time frame
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.	—

Countries

Kazakhstan

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026