Fibroid UterusMIFARTNCT03796130
Does Myomectomy for Intramural Fibroid Improve ART Outcome?
A study testing Myomectomy in people with Fibroid Uterus, run by Mansoura University at 1 site in Egypt.
Trial summary
Intamural fibroids (myoma) do exist in some infertile women undergoing IVF treatment. There is controversy whether myomectomy before IVF treatment could improve IVF outcome. This trial will examine whether myomectomy in those patients could improve the results. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Fibroid Uterus
- What is being tested?
- Myomectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2019to Apr 2021
- Phase
- Interventional
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with intramural fibroid without any cavity involvement
- Age ˂ 35 years
- I onCSI or IVF cycles
- normal uterine cavity
Who cannot join
- low ovarian reserve (AFC < 7 and or AMH < 1.1 ng/ml)
- Endometrioma
- Untreated hydrosalpinx
- Non obstructive azoospermia
- Any other cavitary lesions (Asherman syndrome, Mullerian anomalies)
- recurrent implantation failure
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35111
About this study
Official title: Does Myomectomy for Intramural Fibroid Improve ART Outcome? A Randomized Controlled Trial
Intamural fibroids (myoma) do exist in some infertile women undergoing IVF treatment. There is controversy whether myomectomy before IVF treatment could improve IVF outcome. This trial will examine whether myomectomy in those patients could improve the results.
Read the detailed description
This study will include women who have intramural myoma ranging from 3-5 cm
The participants will be randomly allocated into two groups.
In group (1): myomectomy will be performed before ART
In group (2):women will have their trial of ART without myomectomy
In group A, ART will be performed 3 months after myomectomy if the uterine cavity is not opened and 6 months after myomectomy upon inadvertent opening of the uterine cavity during surgery
- Conditions
- Fibroid Uterus
- Being tested
- Myomectomy
- Medical subject headings
- Leiomyoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyomectomyProcedure or surgery
This study will include women who have intramural myomas ranging from 3-5 cm
The participants will be randomly allocated into two groups.
In group (1): myomectomy will be performed before ART
In group (2):women will have their trial of ART without myomectomy
In group A, ART will be performed 3 months after myomectomy if the uterine cavity is not opened and 6 months after myomectomy upon inadvertent opening of the uterine cavity during surgery
| Study group | Role | What they receive |
|---|---|---|
| (A)Myomectomy | Experimental | This study will include women who have intramural myomas ranging from 3-5 cm
The participants will be randomlyallocated intotwo groups.
In group (A): myomectomy will be performed before ART
In group 1, ART will be performed 3 months after myomectomy if the uterine cavity is not opened and 6 months after myomectomy upon inadvertent opening of the uterine cavity during surgery Receives: Procedure: Myomectomy |
| (B) No myomectomy | No intervention | This study will include women who have intramural myomas ranging from 3-5 cm The participants will be randomly allocated into two groups. In group (B):women will have their trial of ART without myomectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be ongoing pregnancy rate
Pregnancy continued after 12 week gestation per randomised women
Measured: 3 months after embryo transfer
Secondary outcomes (2)
-Implantation rate
Measured: 15 days after embryo transfer
-clinical pregnancy rate
Measured: 5 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2019
- Study start1 Dec 2019
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibroid UterusStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University, Zagazig University, Sohag University, Assiut University
- Responsible party
- Principal investigator, Ahmed Gibreel, Mansoura University
- Investigators
- Ahmed Gibreel, MD, Principal investigator, Mansoura UniversityMohamed S Abdelhafez, MD, Study director, Mansoura UniversitySalah Rasheed, MD, Study director, Sohag UniversityAhmed Nasr, MD, Study director, Assiut UniversitHisham A Saleh, MD, Study director, Alexandria UniversityHassan El Maghraby, MD, Study director, Alexandria UniversityEman El Gindy, MD, Study chair, Zagazig UniversityHoda Sibai, MD, Study director, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03796130
- Sponsor's protocol ID
- H0008
- Acronym
- MIFART
- Status last verified
- Nov 2019
- First submitted
- 4 Jan 2019
- Last updated
- 16 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Myomectomy for Intramural Fibroid Improve ART Outcome? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03796130
- Acronym / sponsor ID
- MIFART / H0008
- Conditions
- Fibroid Uterus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Collaborators
- Alexandria University, Zagazig University, Sohag University, Assiut University
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 8 Jan 2019 (actual)
- 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.
Intamural fibroids (myoma) do exist in some infertile women undergoing IVF treatment. There is controversy whether myomectomy before IVF treatment could improve IVF outcome. This trial will examine whether myomectomy in those patients could improve the results.
Detailed description
This study will include women who have intramural myoma ranging from 3-5 cm
The participants will be randomly allocated into two groups.
In group (1): myomectomy will be performed before ART
In group (2):women will have their trial of ART without myomectomy
In group A, ART will be performed 3 months after myomectomy if the uterine cavity is not opened and 6 months after myomectomy upon inadvertent opening of the uterine cavity during surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (A)Myomectomy | Experimental | Procedure: MyomectomyThis study will include women who have intramural myomas ranging from 3-5 cm The participants will be randomlyallocated intotwo groups. In group (A): myomectomy will be performed before ART In group 1, ART will be performed 3 months after myomectomy if the uterine cavity is not opened and 6 months after myomectomy upon inadvertent opening of the uterine cavity during surgery |
| (B) No myomectomy | No intervention | –This study will include women who have intramural myomas ranging from 3-5 cm The participants will be randomly allocated into two groups. In group (B):women will have their trial of ART without myomectomy |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women with intramural fibroid without any cavity involvement
- Age ˂ 35 years
- I onCSI or IVF cycles
- normal uterine cavity
Key exclusion criteria (6 listed)
- low ovarian reserve (AFC < 7 and or AMH < 1.1 ng/ml)
- Endometrioma
- Untreated hydrosalpinx
- Non obstructive azoospermia
- Any other cavitary lesions (Asherman syndrome, Mullerian anomalies)
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 |
|---|---|---|
| MyomectomyThis study will include women who have intramural myomas ranging from 3-5 cm The participants will be randomly allocated into two groups. In group (1): myomectomy will be performed before ART In group (2):women will have their trial of ART without myomectomy In group A, ART will be performed 3 months after myomectomy if the uterine cavity is not opened and 6 months after myomectomy upon inadvertent opening of the uterine cavity during surgery | Procedure or surgery | (A)Myomectomy |
Primary outcome
The primary outcome will be ongoing pregnancy rate
Time frame: 3 months after embryo transfer
Pregnancy continued after 12 week gestation per randomised women
2 secondary outcomes
-Implantation rate
Time frame: 15 days after embryo transfer
-clinical pregnancy rate
Time frame: 5 weeks after embryo transfer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2019.
- Individual participant dataSharing planned: Yes
Related trials for Fibroid Uterus
Active, not recruiting
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Hereditary Leiomyomatosis Renal Cell Cancer - Study of the Genetic Cause and the Predisposition to Renal Cancer
Renal Tumor Histology, Cutaneous Leiomyoma
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Life Study: Lifestyle Intervention in Fibroid Elimination
Uterine Fibroid
Not yet recruiting
Office Hysteroscopy Versus Operating-room Hysteroscopy for Uterine Lesions
Uterine Polyps, Uterine Fibroids
RecruitingObservational study
Predictors of Success and Failure of v-NOTES Hysterectomy for Large and Very Large Uteri
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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.
Ahmed Gibreel, MD principal investigator
Mansoura University
Mohamed S Abdelhafez, MD study director
Mansoura University
Salah Rasheed, MD study director
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myomectomy in people with Fibroid Uterus, run by Mansoura University at 1 site in Egypt.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 16 Dec 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eman ElGindy, MD, PhD (01227491143, eman_elgindy2013@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome will be ongoing pregnancy rate (time frame: 3 months after embryo transfer). 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 16 Dec 2019.