LeiomyomasPhase 2EFUNCT00839722
Fertility After Uterine Artery Embolisation for the Treatment of Leiomyomas
A Phase 2 study testing embolization in people with Leiomyomas and Fertility, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The main goal of this study is to evaluate spontaneous fertility after uterine leiomyomas embolization, in women between 18 and 40 years old. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Leiomyomas, Fertility
- What is being tested?
- embolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to Jul 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
The main goal of this study is to evaluate spontaneous fertility after uterine leiomyomas embolization, in women between 18 and 40 years old.
Read the detailed description
Uterine artery embolization (UAE) is an effective treatment for leiomyomas, that has been proposed to replace hysterectomy in women who don't want any more pregnancy. Few authors have investigated the results of UAE in women desiring subsequent pregnancy. It might represents an alternative to multiples myomectomies by laparotomy , which results on postoperative fertility remain disappointing. The main goal of this study is to evaluate spontaneous fertility after uterine embolization, in women between 18 and 40 years old. The functional outcome, the efficiency, complications and side-effects of UAE will be also reported especially on the reproduction function. This will be an open prospective, multicentric, non-randomized, interventional study. Within the context of an experimental phase II essay, an optimal Simon plan with 2 stages is required. The current study is the first step. It will include 30 patients treated in the Gynecology departments of Pr MADELENAT and Pr Mathieu CAPUTO (BICHAT Hospital, Paris) and Pr Ville (Poissy Hospital, Poissy). Preliminary results will be reported at 1 year postoperative which correspond to the participation period of 15 months and the total follow-up period will be 2 years. Inclusion criteria will be the women whom multiples myomectomies by laparotomy would be necessary, with symptomatic myoma and an immediate wish of pregnancy. The number of first pregnancies among women who try to be pregnant (conception rate) and among all women (fertility rate) will be calculated. The effects of the embolisation on the genital physiology, the leiomyomas and the ovarian function will be evaluated by questionaries, clinical examination, biology exams (hormones), ultrasound and IRM at 3, 6 and 12 months, and coelioscopy and hysteroscopy at 3 months. The pregnancy progress will be evaluated in a longer study.
- Conditions
- Leiomyomas, Fertility
- Being tested
- embolization
- Keywords
- Uterine embolization, leiomyomas, fertility, myomectomies
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
embolizationProcedure or surgery
fertility after embolization
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | fertility after embolization Receives: Procedure: embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main goal of this study is to evaluate spontaneous fertility after uterine embolization, in women between 18 and 40 years old
Measured: 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
Measured: 18 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeiomyomasStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Pierre PELAGE, PUPH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839722
- Sponsor's protocol ID
- P071006
- Acronym
- EFU
- Status last verified
- Jun 2011
- First submitted
- 6 Feb 2009
- Last updated
- 20 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fertility After Uterine Artery Embolisation for the Treatment of Leiomyomas
- ClinicalTrials.gov ID
- NCT00839722
- Acronym / sponsor ID
- EFU / P071006
- Conditions
- Leiomyomas, Fertility
- Keywords
- Uterine embolization, leiomyomas, fertility, myomectomies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 9 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main goal of this study is to evaluate spontaneous fertility after uterine leiomyomas embolization, in women between 18 and 40 years old.
Detailed description
Uterine artery embolization (UAE) is an effective treatment for leiomyomas, that has been proposed to replace hysterectomy in women who don't want any more pregnancy. Few authors have investigated the results of UAE in women desiring subsequent pregnancy. It might represents an alternative to multiples myomectomies by laparotomy , which results on postoperative fertility remain disappointing. The main goal of this study is to evaluate spontaneous fertility after uterine embolization, in women between 18 and 40 years old. The functional outcome, the efficiency, complications and side-effects of UAE will be also reported especially on the reproduction function. This will be an open prospective, multicentric, non-randomized, interventional study. Within the context of an experimental phase II essay, an optimal Simon plan with 2 stages is required. The current study is the first step. It will include 30 patients treated in the Gynecology departments of Pr MADELENAT and Pr Mathieu CAPUTO (BICHAT Hospital, Paris) and Pr Ville (Poissy Hospital, Poissy). Preliminary results will be reported at 1 year postoperative which correspond to the participation period of 15 months and the total follow-up period will be 2 years. Inclusion criteria will be the women whom multiples myomectomies by laparotomy would be necessary, with symptomatic myoma and an immediate wish of pregnancy. The number of first pregnancies among women who try to be pregnant (conception rate) and among all women (fertility rate) will be calculated. The effects of the embolisation on the genital physiology, the leiomyomas and the ovarian function will be evaluated by questionaries, clinical examination, biology exams (hormones), ultrasound and IRM at 3, 6 and 12 months, and coelioscopy and hysteroscopy at 3 months. The pregnancy progress will be evaluated in a longer study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: embolizationfertility after embolization |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| embolizationfertility after embolization | Procedure or surgery | 1 |
Primary outcome
The main goal of this study is to evaluate spontaneous fertility after uterine embolization, in women between 18 and 40 years old
Time frame: 18 MONTHS
1 secondary outcome
The functional outcome, the efficiency, complications and side-effects of UAE will be also reported especially on the reproduction function
Time frame: 18 MONTHS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Pierre PELAGE, PUPH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing embolization in people with Leiomyomas and Fertility, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main goal of this study is to evaluate spontaneous fertility after uterine embolization, in women between 18 and 40 years old (time frame: 18 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2019.