Uterine Fibroids, With Unexplained InfertilityNCT00730886
ExAblate Treatment of Uterine Fibroids for Fertility Enhancement
A study testing ExAblate 2000 and Myomectomy in people with Uterine Fibroids, With Unexplained Infertility, run by InSightec at 6 sites in United States.
Trial summary
The objective of this trial is to evaluate the efficacy and safety of the ExAblate 2000 system for enhancement of fertility in women with non-hysteroscopically resectable uterine fibroids, who are diagnosed with unexplained infertility. Uterine fibroids are fairly common in women of child-bearing age. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women only
- Conditions the study is for
- Uterine Fibroids, With Unexplained Infertility
- What is being tested?
- ExAblate 2000 and Myomectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 6 sitesUnited States
- Study dates
- Jul 2008to 6 Oct 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female Partner
- Able and willing to give consent
- Able to attend all study visits.
- At least one fibroid 3.0 cm or larger which is type 2 submucosal or intramural touching or abutting the cavity.
- Able to communicate sensations during the ExAblate procedure.
- Uterine fibroids, which are device accessible
Show all 21Show fewer
- Fibroids(s) clearly visible on non-contrast MRI. and with uniform enhancement with gadolinium
- Age 21 to 40 (patients cannot be treated following their 41st birthday)
- Patients with uterine cavitary distortion based on MRI images or ultrasound.
- Premenopausal status
- Normal pap smear and/or HPV testing within institutional guidelines
- At least one ovary and at least one ipsilateral patent fallopian tube confirmed b hysterosalpingogram or laparoscopy.
- Normal serum follicle-stimulating hormone and thyrotropin values on days 1-5 of the cycle
- Length of 2 of the 3 most recent menstrual cycles between 24 and 35 days.
- History of trying for pregnancy for at least 6 months
- Documentation of ovulation using urine LH testing, serum LH testing, serum progesterone > 4 ng/dl or endometrial biopsy showing secretory endometrium in a cycle between 24 and 35 days
- Patient needs to demonstrate that she has already undergone testing and counseling in a fertility clinic or other medical office.
- Male partner inclusion criteria
- Age of male partner < 55
- At least 10 million total mobile sperm on semen analysis within last 6 months
- Use of donor sperm which includes at least 10 million total mobile sperm, for female candidates who otherwise meet eligibility criteria (e.g., single women, etc)
Who cannot join
- Uterine size > 16 weeks
- Prior surgical intervention for fibroids (including UAE) except uncomplicated myomectomy (hysteroscopic, laparoscopic or abdominal) and MRgFUS.
- Prior use of in vitro fertilization or other assisted reproductive technology
- Previous treatment with gonadotropins or intrauterine inseminations
- History of tubal surgery
- History of oophorectomy
Show all 43Show fewer
- History of chemotherapy or radiation to the abdomen or pelvis
- MRI showing only adenomyosis
- Metallic implants that are incompatible with MRI
- Severe claustrophobia that would prevent completion of procedure in MR unit
- Patients with a BMI greater than 38.
- Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist) including severe kidney disease
- Individuals who are not able or willing to tolerate the required prolonged stationary prone position during treatment (approximately 3 hrs.)
- Active pelvic inflammatory disease (PID)
- Active local or systemic infection
- Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia
- Dermoid cyst of the ovary anywhere in the treatment path
- Extensive abdominal scarring that cannot be avoided by redirection of the beam (e.g., due to Caesarean section or repeated abdominal surgeries)
- Undiagnosed vaginal bleeding
- Patients having a contraindication to pregnancy.
- Patients having a contraindication to surgery, including surgical myomectomy
- Patients with type 0 submucosal fibroids.
- More than 4 clinically significant fibroids >2cm in mean diameters
- Patients on dialysis.
- Hematocrit < 25
- Hemolytic anemia
- Patients with unstable cardiac status including:
- Unstable angina pectoris on medication
- Patients with documented myocardial infarction within six months of protocol entry
- Congestive heart failure requiring medication (other than diuretic)
- Patients on anti-arrhythmic drugs
- Severe hypertension (diastolic BP > 100 on medication)
- Patients with cardiac pacemakers
- Patients planning to use adjuvant therapies post (ExAblate or Myomectomy) procedures to improve the chance of conception within 9 months of study treatment will be excluded from study (note: candidates relying on donor sperm and artificial insemination to conceive between months 3 and 9 post-treatment are allowed to participate, provided they meet all eligibility criteria)
- Patients without uterine cavity distortion.
- Male partner exclusion criteria
- Prior use of in vitro fertilization of other assisted reproductive technology
- Previous treatment intrauterine inseminations
- History of chemotherapy or radiation to the abdomen or pelvis
- History of vasovasectomy
- History of varicocelectomy
- History of pelvic-node dissection
- Use of calcium-channel blocking medications
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Virginia Health System
Charlottesville, Virginia, 22908
Duke University
Durham, North Carolina, 27713
UCLA
Los Angeles, California, 90095
Willowbend Health and Wellness
Plano, Texas, 75093
Mayo Clinic
Rochester, Minnesota, 55905
Atlanta Interventional Institute
Smyrna, Georgia, 30080
About this study
Official title: A Randomized Study to Evaluate the Effectiveness and Safety of ExAblate Surgery Compared With Myomectomy for the Enhancement of Fertility Following Treatment of Uterine Fibroids in Women Seeking Pregnancy
The objective of this trial is to evaluate the efficacy and safety of the ExAblate 2000 system for enhancement of fertility in women with non-hysteroscopically resectable uterine fibroids, who are diagnosed with unexplained infertility.
Uterine fibroids are fairly common in women of child-bearing age. An evidence based review supported removing fibroids that distort the uterine cavity to increase pregnancy rates and decrease the rates of miscarriage. Some fibroids can be removed hysteroscopically which is minimally invasive, with low morbidity. However, removal of fibroids within the uterine wall require more invasive surgical procedures (e.g., myomectomy), with increasing morbidity risks including, but not limited to, infection, blood loss and postoperative uterine adhesions.
ExAblate is approved by FDA for the treatment of uterine fibroids; however, its use in patients seeking pregnancy is considered experimental. Accumulated evidence suggests there are no significant complications from the procedure in women seeking pregnancy as with existing fibroid therapies; however, these data are based on a small number of patients. This study will evaluate fertility enhancement following ExAblate treatment or myomectomy, in women with unexplained infertility and who have non-hysteroscopically resectable uterine fibroids.
- Being tested
- ExAblate 2000, Myomectomy
- Keywords
- Uterine Fibroids, Unexplained Infertility, MRgFUS, ExAblate, Focused Ultrasound, Myomectomy
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblate 2000Device
Magnetic resonance image guided focused ultrasound (MRgFUS) for fibroid ablation
MyomectomyProcedure or surgery
Invasive surgical procedure for fibroid removal
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Non-invasive procedure for fertility enhancement (i.e., ExAblate treatment) Receives: Device: ExAblate 2000 |
| 2 | Active comparator | Invasive surgical procedure for fertility enhancement (i.e., myomectomy) Receives: Procedure: Myomectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live Birth Rate
Measured: Between the 3 and 9-month post-treatment visits
Secondary outcomes (9)
Pregnancy Rate
Measured: Between the 3 and 15-month post-treatment visits
Term Delivery Rate
Measured: Between the 3 and 15-month post-treatment visits
Miscarriage Rate
Measured: Between the 3 and 15-month post-treatment visits
Time to Conception
Measured: Post-treatment
C-Section Rate
Measured: Post-treatment
Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL)
Measured: Post-treatment
Center for Epidemiologic Studies Depression Scale (CES-D)
Measured: Post-treatment
Medical Outcomes Study 36-Item Short Form Survey
Measured: Post-treatment
Health Care Costs
Measured: Post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionJul 2011
- Study completion6 Oct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Uterine Fibroids, With Unexplained InfertilityStudies of the same condition, open and under way.
- More trials run by InSightecThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- InSightec
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730886
- Sponsor's protocol ID
- UF023
- Status last verified
- Aug 2018
- First submitted
- 5 Aug 2008
- Last updated
- 15 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hanstede MM, Tempany CM, Stewart EA. Focused ultrasound surgery of intramural leiomyomas may facilitate fertility: a case report. Fertil Steril. 2007 Aug;88(2):497.e5-7. doi: 10.1016/j.fertnstert.2006.11.103. Epub 2007 Feb 8.
PubMed 17292361Rabinovici J, David M, Fukunishi H, Morita Y, Gostout BS, Stewart EA; MRgFUS Study Group. Pregnancy outcome after magnetic resonance-guided focused ultrasound surgery (MRgFUS) for conservative treatment of uterine fibroids. Fertil Steril. 2010 Jan;93(1):199-209. doi: 10.1016/j.fertnstert.2008.10.001. Epub 2008 Nov 14.
PubMed 19013566Bouwsma EV, Gorny KR, Hesley GK, Jensen JR, Peterson LG, Stewart EA. Magnetic resonance-guided focused ultrasound surgery for leiomyoma-associated infertility. Fertil Steril. 2011 Jul;96(1):e9-e12. doi: 10.1016/j.fertnstert.2011.04.056. Epub 2011 May 13.
PubMed 21570071
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Evaluate the Effectiveness and Safety of ExAblate Surgery Compared With Myomectomy for the Enhancement of Fertility Following Treatment of Uterine Fibroids in Women Seeking Pregnancy
- ClinicalTrials.gov ID
- NCT00730886
- Acronym / sponsor ID
- UF023
- Keywords
- Uterine Fibroids, Unexplained Infertility, MRgFUS, ExAblate, Focused Ultrasound, Myomectomy
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- InSightecIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- 6 Oct 2011 (actual)
- First posted
- 8 Aug 2008 (estimated)
- Results
- Posted 15 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this trial is to evaluate the efficacy and safety of the ExAblate 2000 system for enhancement of fertility in women with non-hysteroscopically resectable uterine fibroids, who are diagnosed with unexplained infertility.
Uterine fibroids are fairly common in women of child-bearing age. An evidence based review supported removing fibroids that distort the uterine cavity to increase pregnancy rates and decrease the rates of miscarriage. Some fibroids can be removed hysteroscopically which is minimally invasive, with low morbidity. However, removal of fibroids within the uterine wall require more invasive surgical procedures (e.g., myomectomy), with increasing morbidity risks including, but not limited to, infection, blood loss and postoperative uterine adhesions.
ExAblate is approved by FDA for the treatment of uterine fibroids; however, its use in patients seeking pregnancy is considered experimental. Accumulated evidence suggests there are no significant complications from the procedure in women seeking pregnancy as with existing fibroid therapies; however, these data are based on a small number of patients. This study will evaluate fertility enhancement following ExAblate treatment or myomectomy, in women with unexplained infertility and who have non-hysteroscopically resectable uterine fibroids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: ExAblate 2000Non-invasive procedure for fertility enhancement (i.e., ExAblate treatment) |
| 2 | Active comparator | Procedure: MyomectomyInvasive surgical procedure for fertility enhancement (i.e., myomectomy) |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (21 listed)
- Female Partner
- Able and willing to give consent
- Able to attend all study visits.
- At least one fibroid 3.0 cm or larger which is type 2 submucosal or intramural touching or abutting the cavity.
- Able to communicate sensations during the ExAblate procedure.
Key exclusion criteria (43 listed)
- Uterine size > 16 weeks
- Prior surgical intervention for fibroids (including UAE) except uncomplicated myomectomy (hysteroscopic, laparoscopic or abdominal) and MRgFUS.
- Prior use of in vitro fertilization or other assisted reproductive technology
- Previous treatment with gonadotropins or intrauterine inseminations
- History of tubal surgery
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 |
|---|---|---|
| ExAblate 2000Magnetic resonance image guided focused ultrasound (MRgFUS) for fibroid ablation | Device | 1 |
| MyomectomyInvasive surgical procedure for fibroid removal | Procedure or surgery | 2 |
Primary outcome
Live Birth Rate
Time frame: Between the 3 and 9-month post-treatment visits
9 secondary outcomes
Pregnancy Rate
Time frame: Between the 3 and 15-month post-treatment visits
Term Delivery Rate
Time frame: Between the 3 and 15-month post-treatment visits
Miscarriage Rate
Time frame: Between the 3 and 15-month post-treatment visits
Time to Conception
Time frame: Post-treatment
C-Section Rate
Time frame: Post-treatment
Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL)
Time frame: Post-treatment
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Post-treatment
Medical Outcomes Study 36-Item Short Form Survey
Time frame: Post-treatment
Health Care Costs
Time frame: Post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17292361Hanstede MM, Tempany CM, Stewart EA. Focused ultrasound surgery of intramural leiomyomas may facilitate fertility: a case report. Fertil Steril. 2007 Aug;88(2):497.e5-7. doi: 10.1016/j.fertnstert.2006.11.103. Epub 2007 Feb 8.
- Background: PubMed 19013566Rabinovici J, David M, Fukunishi H, Morita Y, Gostout BS, Stewart EA; MRgFUS Study Group. Pregnancy outcome after magnetic resonance-guided focused ultrasound surgery (MRgFUS) for conservative treatment of uterine fibroids. Fertil Steril. 2010 Jan;93(1):199-209. doi: 10.1016/j.fertnstert.2008.10.001. Epub 2008 Nov 14.
- Derived from this study: PubMed 21570071Bouwsma EV, Gorny KR, Hesley GK, Jensen JR, Peterson LG, Stewart EA. Magnetic resonance-guided focused ultrasound surgery for leiomyoma-associated infertility. Fertil Steril. 2011 Jul;96(1):e9-e12. doi: 10.1016/j.fertnstert.2011.04.056. Epub 2011 May 13.
- Sponsor's Web PageLink provided by the sponsor.
Related trials for Uterine Fibroids, With Unexplained Infertility
Active, not recruitingPhase 3
FRIEND: Fibroids and Unexplained Infertility Treatment With Epigallocatechin Gallate; A Natural CompounD in Green Tea
Leiomyoma, Uterine
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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExAblate 2000 and Myomectomy in people with Uterine Fibroids, With Unexplained Infertility, run by InSightec at 6 sites in United States.
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 21 inclusion and 43 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: stopped early, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Live Birth Rate (time frame: Between the 3 and 9-month post-treatment visits). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00730886, which also lists 3 linked publications.
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 15 Aug 2018.