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| Name | Class |
|---|---|
| Alexandria University | OTHER |
| Zagazig University | OTHER_GOV |
| Sohag University | OTHER |
| Assiut University |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (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 |
|
| (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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Myomectomy | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome will be ongoing pregnancy rate | Pregnancy continued after 12 week gestation per randomised women | 3 months after embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| -Implantation rate | 15 days after embryo transfer | |
| -clinical pregnancy rate | 5 weeks after embryo transfer |
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Inclusion Criteria:
Exclusion Criteria:
Women
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eman ElGindy, MD, PhD | Contact | 01227491143 | eman_elgindy2013@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed Gibreel, MD | Mansoura University | Principal Investigator |
| Mohamed S Abdelhafez, MD | Mansoura University | Study Director |
| Salah Rasheed, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University Hospital | Recruiting | Al Mansurah | Dakahlia Governorate | 35111 | Egypt |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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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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| OTHER |
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| Sohag University |
| Study Director |
| Ahmed Nasr, MD | Assiut Universit | Study Director |
| Hisham A Saleh, MD | Alexandria University | Study Director |
| Hassan El Maghraby, MD | Alexandria University | Study Director |
| Eman El Gindy, MD | Zagazig University | Study Chair |
| Hoda Sibai, MD | Zagazig University | Study Director |
| Hamed Yossef, MD | Mansoura University | Study Chair |