Clinical trial NCT02563392: Does Preventive Uterine Artery Occlusion During Laparoscopic Myomectomy Impact on Ovarian Reserve Markers?
Official title: Does Preventive Uterine Artery Occlusion During Laparoscopic Myomectomy Impact on Ovarian Reserve Markers? A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Myoma
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Objectives:

1. To assess the effect of preventive uterine artery occlusion during laparoscopic myomectomy on ovarian reserve parameters;
2. To evaluate the effect of preventive uterine artery occlusion during laparoscopic myomectomy on intra- and postoperative blood loss, operative time, clinical symptoms improvement, long-term recurrence of myomas and fertility.

Materials and methods:

Design: This is a prospective randomized single blind trial, including 60 women undergoing a laparoscopic myomectomy for symptomatic uterine myomas. Patients are randomized into two groups: a control group "myomectomy alone" and an experimental group "myomectomy with preventive uterine arteries occlusion".

Setting: The duration of the study will normally be 5 years and will take place at the University Hospitals of Geneva. The study will include about 20 women per year and follow-up will last 2 years. Inclusion criteria are: women of childbearing age, wishing to retain their uterus, having symptomatic uterine myomas and who are eligible for a laparoscopic myomectomy.

The parameters that will be intraoperatively evaluated are the operation time, blood loss and the complications of the surgical technique. Postoperative complications, improving clinical symptoms, myomas recurrence and fertility are discussed at short and long term follow-up.

The ovarian reserve will be evaluated pre- and postoperatively for each patient. It will be determined by plasmatic AMH (anti-Mullerian Hormone) and ultrasound antral follicle count. Women with undetectable preoperative plasmatic AMH will be excluded from the study. Plasmatic AMH and antral follicle count will be measured at 1, 3, 6, 12 and 24 months during the postoperative follow-up.

Limitations:

The sample size is calculated in order to demonstrate a significant difference in plasmatic AMH before and after myomectomy. Small differences are not highlighted in this study, but they probably would not have any impact in clinical practice.

Impact of the study:

The results of this study could have a real impact on daily surgical practice. In case of persistent alteration of ovarian reserve in the experimental group compared to the control group, preventive uterine arteries occlusion during a laparoscopic myomectomy should only be indicated in patients who do not wish pregnancy. If there is no significant impact on ovarian reserve and a beneficial effect on reducing intraoperative blood loss and long-term improvement of symptoms, it should be systematically proposed in all patients undergoing a laparoscopic myomectomy.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Evolution of ovarian reserve markers after myomectomy
timeFrame: Evaluation of the ovarian reserve at several times: on preoperative, 1, 3, 6, 12 and 24 months postoperative
Secondary outcomes:
measure: Intra-and post-operative blood loss
timeFrame: peroperative
measure: operative time
timeFrame: peroperative
measure: peroperative complications
timeFrame: peroperative
measure: Clinical symptoms improvement: hypermenorrhea
timeFrame: 1, 3, 6, 12 and 24 months postoperative
measure: Clinical symptoms improvement: dysmenorrhea
timeFrame: 1, 3, 6, 12 and 24 months postoperative
measure: Clinical symptoms improvement: occuring of pregnancy
timeFrame: 12 and 24 months postoperative
measure: long-term recurrence of myomas
timeFrame: 2 years
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève, Service de gynécologie
Study officials:
affiliation: University Hospital, Geneva
name: Patrick Petignat, Pr
role: STUDY_DIRECTOR
References: