Does Preventive Uterine Artery Occlusion During Laparoscopic Myomectomy Impact on Ovarian Reserve Markers?

NCT02563392 | Completed

• 1 other identifier: 14-129
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

Hysterectomy is an effective treatment used as a first-line approach for uterine myomas. Several others alternatives to hysterectomy have been developed in recent years for women wishing to retain their uterus: myomectomy, radiological embolization, focused ultrasound. Myomectomy, particularly through minimally invasive surgery, is currently considered the conservative treatment of choice for patients wishing to preserve their fertility. However, three important issues should be considered: the risk of intra- and postoperative bleeding, the risk for recurring myomas, and the preservation of subsequent fertility. Preventive uterine artery occlusion can be combined with laparoscopic myomectomy in order to avoid bleeding and improve uterine suture. Another expected long-term benefit is the improvement of treatment efficacy, leading to less symptoms and myomas recurrence. However, the effect of uterine arteries occlusion on the ovarian reserve of women of childbearing age has not yet been studied, which limits its clinical application.

Conditions

Uterine Myoma

Outcome Measures

Primary Outcomes (1)

• Evolution of ovarian reserve markers after myomectomy

  It will be determined by plasmatic AMH and ultrasound antral follicle count

  Evaluation of the ovarian reserve at several times: on preoperative, 1, 3, 6, 12 and 24 months postoperative

Secondary Outcomes (7)

• Intra-and post-operative blood loss

  peroperative

• operative time

  peroperative

• peroperative complications

  peroperative

• Clinical symptoms improvement: hypermenorrhea

  1, 3, 6, 12 and 24 months postoperative

• Clinical symptoms improvement: dysmenorrhea

  1, 3, 6, 12 and 24 months postoperative

Study Arms (2)

Uterine arteries occlusion

EXPERIMENTAL

Laparoscopic myomectomy with preventive uterine arteries occlusion

Procedure: uterine myomectomy with preventive uterine arteries occlusion

No uterine arteries occlusion

ACTIVE COMPARATOR

Laparoscopic myomectomy without preventive uterine arteries occlusion

Procedure: laparoscopic uterine myomectomy without preventive uterine arteries occlusion

Interventions

uterine myomectomy with preventive uterine arteries occlusion PROCEDURE

laparoscopic uterine myomectomy with preventive uterine arteries occlusion

Uterine arteries occlusion

laparoscopic uterine myomectomy without preventive uterine arteries occlusion PROCEDURE

laparoscopic uterine myomectomy

No uterine arteries occlusion

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• over 18 years
• signed the surgery consent form
• capable of discernment understanding and accepting the risks and benefits of the operation
• symptomatic : menorrhagia, breakthrough bleeding and / or pelvic pain and / or infertility and / or repeated spontaneous abortions.
• uterine myoma or more, including at least one type of myoma FIGO 2-6 (International Federation of Gynecology and Obstetrics) objectified by ultrasound and / or pelvic MRI
• laparoscopic approach is technically feasible (as recommended by the National College of Obstetrics and Gynecology French published in 2011): myoma single lower or equal to 9 cm or sum of the size of myomas in centimeters or less equal to 13 and number of myomas inferior to four.
• Female patients of childbearing age younger than 45 years and having a plasma AMH (anti-Mullerian hormone) than 3 pmol / l.
• Patients who accept a postoperative follow-up of 2 years

You may not qualify if:

• pregnant patients.
• who underwent radiological uterine artery embolization.
• who have an undetectable AMH levels (\<3 pmol / l).
• over 45 years

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Hôpitaux Universitaires de Genève, Service de gynécologie

Geneva, 1206, Switzerland

Location

Related Publications (1)

• Streuli I, Ramyead L, Silvestrini N, Petignat P, Dubuisson J. Impact of definitive uterine artery occlusion on ovarian reserve markers in laparoscopic myomectomy: a randomized controlled trial with 2-year follow-up. Hum Reprod. 2025 Jul 1;40(7):1305-1314. doi: 10.1093/humrep/deaf070.

  PMID: 40420404 DERIVED

MeSH Terms

Conditions

Myofibroma

Interventions

Uterine Myomectomy

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Patrick Petignat, Pr

  University Hospital, Geneva

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: July 9, 2015
• First Posted: September 30, 2015
• Study Start: April 1, 2015
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Locations

CH (1)