Effect of Myomectomy for Intramural Myoma on Fertility Outcomes in Infertile Women
1 other identifier
interventional
100
1 country
2
Brief Summary
The aim of this study is to evaluate the effect of myomectomy for intramural myomas on the fertility outcomes in infertile women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2017
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 4, 2017
CompletedFirst Posted
Study publicly available on registry
May 8, 2017
CompletedStudy Start
First participant enrolled
May 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2021
CompletedAugust 26, 2020
August 1, 2020
4.1 years
May 4, 2017
August 23, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical pregnancy rate
Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 6-8 weeks gestational age) divided by the number of women
6-8 weeks gestational age
Secondary Outcomes (1)
Miscarriage rate
12 weeks gestational age
Study Arms (2)
Myomectomy
EXPERIMENTALWomen will be subjected to laparotomy to remove the myomas
Conservative management
NO INTERVENTIONWomen will not be subjected to surgery (conservative management)
Interventions
Laparotomy then incision in the uterine wall to remove the myoma followed by closure of the uterine incision
Eligibility Criteria
You may qualify if:
- Infertility for at least one year.
- Presence of intramural myoma.
- Absence of any other cause of infertility as revealed by basic infertility work up including laparoscopy.
You may not qualify if:
- Age is \< 20 or \> 33 years.
- Symptomatic fibroid causing pelviabdominal swelling.
- Presence of \> 2 myomas.
- Presence of a coexisting another type of myoma other than intramural myoma (e.g. submucosal, subserosal, cervical or ligamentary myoma).
- Presence of any other cause of infertility.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Obstetrics and Gynecology Department in Mansoura University Hospital
Al Mansurah, Dakahlia Governorate, 35111, Egypt
Obstetrics and Gynecology Department in Mansoura University
Port Said, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Waleed El-refaie, Dr
Port Said University
- STUDY DIRECTOR
Khaled Samir, Dr
Mansoura University
- STUDY DIRECTOR
Mahmoud M Awad, Dr
Mansoura University
- STUDY CHAIR
Mohamed S Abdelhafez, Dr
Mansoura University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2017
First Posted
May 8, 2017
Study Start
May 15, 2017
Primary Completion
June 15, 2021
Study Completion
June 15, 2021
Last Updated
August 26, 2020
Record last verified: 2020-08