Does Myomectomy for Intramural Fibroid Improve ART Outcome?
NCT ID: NCT03796130
Last Updated: 2019-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2019-12-01
2021-04-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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(A)Myomectomy
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
Myomectomy
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
(B) No myomectomy
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
No interventions assigned to this group
Interventions
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Myomectomy
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
Eligibility Criteria
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Inclusion Criteria
* Age ˂ 35 years
* I onCSI or IVF cycles
* normal uterine cavity
Exclusion Criteria
* Endometrioma
* Untreated hydrosalpinx
* Non obstructive azoospermia
* Any other cavitary lesions (Asherman syndrome, Mullerian anomalies)
* recurrent implantation failure
18 Years
35 Years
FEMALE
No
Sponsors
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Alexandria University
OTHER
Zagazig University
OTHER_GOV
Sohag University
OTHER
Assiut University
OTHER
Mansoura University
OTHER
Responsible Party
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Ahmed Gibreel
Assistant professor
Principal Investigators
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Ahmed Gibreel, MD
Role: PRINCIPAL_INVESTIGATOR
Mansoura University
Mohamed S Abdelhafez, MD
Role: STUDY_DIRECTOR
Mansoura University
Salah Rasheed, MD
Role: STUDY_DIRECTOR
Sohag University
Ahmed Nasr, MD
Role: STUDY_DIRECTOR
Assiut Universit
Hisham A Saleh, MD
Role: STUDY_DIRECTOR
Alexandria University
Hassan El Maghraby, MD
Role: STUDY_DIRECTOR
Alexandria University
Eman El Gindy, MD
Role: STUDY_CHAIR
Zagazig University
Hoda Sibai, MD
Role: STUDY_DIRECTOR
Zagazig University
Hamed Yossef, MD
Role: STUDY_CHAIR
Mansoura University
Locations
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Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, Egypt
Countries
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Central Contacts
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Other Identifiers
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H0008
Identifier Type: -
Identifier Source: org_study_id