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The aim of this study is to evaluate the effect of myomectomy for intramural myomas on the fertility outcomes in infertile women.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Myomectomy | Experimental | Women will be subjected to laparotomy to remove the myomas |
|
| Conservative management | No Intervention | Women will not be subjected to surgery (conservative management) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myomectomy | Procedure | Laparotomy then incision in the uterine wall to remove the myoma followed by closure of the uterine incision |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Miscarriage rate | Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies | 12 weeks gestational age |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Waleed El-refaie, Dr | Contact | +201224515318 | wrefaie@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Waleed El-refaie, Dr | Port Said University | Principal Investigator |
| Khaled Samir, Dr | Mansoura University | Study Director |
| Mahmoud M Awad, Dr |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obstetrics and Gynecology Department in Mansoura University Hospital | Recruiting | Al Mansurah | Dakahlia Governorate | 35111 | Egypt |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
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| ID | Term |
|---|---|
| D063186 | Uterine Myomectomy |
| ID | Term |
|---|---|
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Mansoura University |
| Study Director |
| Mohamed S Abdelhafez, Dr | Mansoura University | Study Chair |
| Obstetrics and Gynecology Department in Mansoura University | Recruiting | Port Said | Egypt |
|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |