Fertility After Uterine Artery Embolisation for the Treatment of Leiomyomas

NCT00839722 | Completed Phase 2

• 1 other identifier: P071006
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The main goal of this study is to evaluate spontaneous fertility after uterine leiomyomas embolization, in women between 18 and 40 years old.

Conditions

Leiomyomas; Fertility

Keywords

Uterine embolization; leiomyomas; fertility; myomectomies

Outcome Measures

Primary Outcomes (1)

• The main goal of this study is to evaluate spontaneous fertility after uterine embolization, in women between 18 and 40 years old

  18 MONTHS

Secondary Outcomes (1)

• The functional outcome, the efficiency, complications and side-effects of UAE will be also reported especially on the reproduction function

  18 MONTHS

Study Arms (1)

1

EXPERIMENTAL

fertility after embolization

Procedure: embolization

Interventions

embolization PROCEDURE

fertility after embolization

1

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• age \> 18 years and ≤ 40 years
• diffuse POLYMYOMATOSIS or recurrent POLYMYOMATOSIS after surgery requiring multiple myomectomies by laparotomies i.e. at least 3 fibroids of significant diameter (including 1 fibroid longer than 3 cm using ultrasound)
• symptomatic fibroids causing chronic pelvic pain and/or pelvic pressure and/or haemorrhage genital
• immediate desire for future pregnancy without indication for assisted medical reproduction (bilateral hydrosalpinx, male infertility)
• covered by french health insurance
• patient knowing to read and understanding French
• patient signing of an informed consent form, after appropriate information has been provided

You may not qualify if:

• evolutionary pregnancy
• medical emergency situation
• Contraindication by the surgery or Uterine Artery Embolisation : allergy, severe renal failure, immune system deficiency or anesthesic
• age \> 40 years
• fibroids accessible to laparoscopies removal (less than 3 fibroids measuring 3 cm or 1 dominant fibroid measuring 8 cm) or hysteroscopies resection (submucous fibroids type 0 or I according to DONNEZ'S classification) or abdominal myomectomy indicated by large volume single intramural or subserosal fibroid
• abnormal hormonal profile at day 3 of the cycle evaluated during a pluridisciplinary consultation
• Male infertility requiring management for assisted medically reproduction (systematic
• spermograms will be obtained in routinely)
• amenorrhea
• visible hydrosalpinx for ultrasonography or MRI
• no explored an adnexal mass
• diffuse adenomyosis as the dominant disease
• no affiliation of social coverage
• bad comprehension of french preventing an informed consent form or information of self questionnaires
• social situation posing to difficulty of follow-up

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Poissy St Germain En Laye

Poissy, 78300, France

Location

MeSH Terms

Conditions

Leiomyoma

Interventions

Embolization, Therapeutic

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Hemostatic Techniques; Therapeutics; Therapeutic Occlusion

Study Officials

• Jean Pierre PELAGE, PUPH

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 9, 2009
• Study Start: February 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2012
• Last Updated: June 20, 2019

Record last verified: 2011-06

Locations

FR (1)