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| Name | Class |
|---|---|
| Ahmed Elgazzar Hospital | OTHER |
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The aim of this study is to determine whether the ultrasound guided aspiration of hydrosalpingeal fluid at the time of oocyte retrieval can improve the outcomes of IVF-ET .
A Cochrane review of prospective randomized trials of laparoscopic salpingectomy confirmed the beneficial effect of laparoscopic salpingectomy on IVF ET outcomes in patients with hydrosalpinges. Surgery is not usually safe especially in patients with extensive adhesions, morbid obesity and previous multiple laparotomies. Other less invasive options for patients with hydrosalpinges as ultrasound guided aspiration of hydrosalpingeal fluid, antibiotics and hysteroscopic occlusion of fallopian tube were studied in order to find an alternative to salpingectomy. Although these methods are simple and getting popular,current data are inadequate to recommend these treatment options instead of salpingectomy. The aim of this study is to determine whether the ultrasound guided aspiration of hydrosalpingeal fluid at the time of oocyte retrieval can improve the outcomes of IVF-ET .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1: Hydrosalpinx needle aspiration | Experimental | After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely . |
|
| 2. no aspiration | No Intervention | IVF-ET is done without prior aspiration of hydrosalpingeal fluid |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrasound guided aspiration of hydrosalpingeal fluid | Procedure | Under deep sedation, the retrieval of oocytes is done and then an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely . If there are bilateral hydrosalpinges, the process is repeated on the opposite side. |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle | The Number of Participants Who Achieved Clinical Pregnancy( presence of intrauterine gestational sac detected by transvaginal ultrasound )in a transfer cycle | 5 weeks after embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle . | The number of participants who Achieved Ongoing pregnancy (pregnancy for more than 18 weeks after embryo transfer) in a transfer cycle . | 18 weeks after embryo transfer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Usama M Fouda, M.D, PhD | Lecturer of obstetrics and Gynecology , Faculty of medicine ,Cairo university. | Study Chair |
| Ahmed M sayed, MD,PhD | Assistant professor of obstetrics and Gynecology , Faculty of medicine ,Cairo university. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ahmed Elgazzar hospital , Assisted conception unit | Giza | 35 Eleshreen Saint King Faisal. | 12111 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18343810 | Background | Hammadieh N, Coomarasamy A, Ola B, Papaioannou S, Afnan M, Sharif K. Ultrasound-guided hydrosalpinx aspiration during oocyte collection improves pregnancy outcome in IVF: a randomized controlled trial. Hum Reprod. 2008 May;23(5):1113-7. doi: 10.1093/humrep/den071. Epub 2008 Mar 13. | |
| 20672903 | Derived | Fouda UM, Sayed AM. Effect of ultrasound-guided aspiration of hydrosalpingeal fluid during oocyte retrieval on the outcomes of in vitro fertilisation-embryo transfer: a randomised controlled trial (NCT01040351). Gynecol Endocrinol. 2011 Aug;27(8):562-7. doi: 10.3109/09513590.2010.507290. Epub 2010 Jul 30. |
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This study was two arm prospective randomized controlled study including 110 fresh IVF- ETs from 110 patients , undertaken between October 2006 to May 2010 at the assisted conception unit of Ahmed Elgazzar hospital , Cairo , Egypt.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1: Hydrosalpinx Needle Aspiration | After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely . |
| FG001 | 2. no Aspiration | IVF-ET is done without prior aspiration of hydrosalpingeal fluid |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1: Hydrosalpinx Needle Aspiration | After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely . |
| BG001 | 2. no Aspiration |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle | The Number of Participants Who Achieved Clinical Pregnancy( presence of intrauterine gestational sac detected by transvaginal ultrasound )in a transfer cycle | Patients undergoing embryo transfer were included in final analysis | Posted | Number | participents | 5 weeks after embryo transfer |
|
October 2006 to May 2010
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1: Hydrosalpinx Needle Aspiration | Aspiration of hydrosalpingeal fluid prior to IVF-ET |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flaring of pelvic infection and peritonitis | Reproductive system and breast disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ovarian hyperstimulation syndrome | Reproductive system and breast disorders | Systematic Assessment |
Several patients refused to participate in the study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Usama M.Fouda, M.D, PhD | Cairo university | +20123595106 | umfrfouda@yahoo.com |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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IVF-ET is done without prior aspiration of hydrosalpingeal fluid |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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IVF-ET is done without prior aspiration of hydrosalpingeal fluid
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|
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| Secondary | The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle . | The number of participants who Achieved Ongoing pregnancy (pregnancy for more than 18 weeks after embryo transfer) in a transfer cycle . | Patients who underwent embryo transfer were included in the final analysis | Posted | Number | participents | 18 weeks after embryo transfer |
|
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| 0 |
| 54 |
| 0 |
| 54 |
| EG001 | 2. no Aspiration | IVF-ET without any prior intervention | 0 | 53 | 0 | 53 |
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