Effect of Myomectomy for Intramural Myoma on Fertility Outcomes in Infertile Women
Primary Purpose
Infertility, Fibroid
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Myomectomy
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Obstetrics and Gynecology Department in Mansoura University HospitalRecruiting
- Obstetrics and Gynecology Department in Mansoura UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Myomectomy
Conservative management
Arm Description
Women will be subjected to laparotomy to remove the myomas
Women will not be subjected to surgery (conservative management)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Miscarriage rate
Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03143114
Brief Title
Effect of Myomectomy for Intramural Myoma on Fertility Outcomes in Infertile Women
Official Title
Effect of Myomectomy for Intramural Myoma on Fertility Outcomes in Infertile Women: a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
June 15, 2021 (Anticipated)
Study Completion Date
June 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to evaluate the effect of myomectomy for intramural myomas on the fertility outcomes in infertile women.
Detailed Description
All women participating in the study will be randomly allocated into two groups; myomectomy group and conservative management group. Women in the myomectomy group will be subjected to laparotomy to remove the myomas while women in the conservative management group will not be subjected to surgery. Women in the myomectomy group will be asked to abstain from having sexual intercourse (or use a barrier contraception method) for 3 months after surgery then to start having regular fertility-oriented intercourse after that. Women in the conservative management group will be asked to immediately start having regular fertility-oriented intercourse. Women in both groups will be monitored form the time of starting regular intercourse and for one year for occurrence of clinical pregnancy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Fibroid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Myomectomy
Arm Type
Experimental
Arm Description
Women will be subjected to laparotomy to remove the myomas
Arm Title
Conservative management
Arm Type
No Intervention
Arm Description
Women will not be subjected to surgery (conservative management)
Intervention Type
Procedure
Intervention Name(s)
Myomectomy
Intervention Description
Laparotomy then incision in the uterine wall to remove the myoma followed by closure of the uterine incision
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
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
Time Frame
6-8 weeks gestational age
Secondary Outcome Measure Information:
Title
Miscarriage rate
Description
Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies
Time Frame
12 weeks gestational age
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
33 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Waleed El-refaie, Dr
Phone
+201224515318
Email
wrefaie@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waleed El-refaie, Dr
Organizational Affiliation
Port Said University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Khaled Samir, Dr
Organizational Affiliation
Mansoura University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mahmoud M Awad, Dr
Organizational Affiliation
Mansoura University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mohamed S Abdelhafez, Dr
Organizational Affiliation
Mansoura University
Official's Role
Study Chair
Facility Information:
Facility Name
Obstetrics and Gynecology Department in Mansoura University Hospital
City
Mansourah
State/Province
Dakahlia
ZIP/Postal Code
35111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed S Abdelhafez, Dr
Facility Name
Obstetrics and Gynecology Department in Mansoura University
City
Port Said
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Waleed El-refaie, Dr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Myomectomy for Intramural Myoma on Fertility Outcomes in Infertile Women
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