A Phase 2 interventional study of ultrasound guided aspiration of hydrosalpingeal fluid in Infertility, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 37 Years. Per ClinicalTrials.gov, last updated 2011-08-29.
Sponsored by Cairo University · Phase 2, Interventional, and Treatment
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 .
2,541 studies on the registry are indexed under Infertility; 405 are open to participants now.
This study's enrollment of 110 is close to the median of 120 across 1,722 interventional studies indexed under Infertility.
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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 .
Procedure: ultrasound guided aspiration of hydrosalpingeal fluid
IVF-ET is done without prior aspiration of hydrosalpingeal fluid
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.
Also known as: ultrasound guided Hydrosalpinx needle aspiration
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
Time frame: 5 weeks after embryo transfer
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 .
Time frame: 18 weeks after embryo transfer
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.
| Milestone | 1: Hydrosalpinx Needle Aspiration | 2. no Aspiration |
|---|---|---|
| Started | 55 | 55 |
| Completed | 54 | 53 |
| Not completed | 1 | 2 |
| Withdrew: Poor ovarian response | 1 | 2 |
The Number of Participants Who Achieved Clinical Pregnancy( presence of intrauterine gestational sac detected by transvaginal ultrasound )in a transfer cycle
| participents | 1: Hydrosalpinx Needle Aspiration | 2. no Aspiration |
|---|---|---|
| The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle | 17 | 7 |
The number of participants who Achieved Ongoing pregnancy (pregnancy for more than 18 weeks after embryo transfer) in a transfer cycle .
| participents | 1: Hydrosalpinx Needle Aspiration | 2. no Aspiration |
|---|---|---|
| The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle . | 15 | 5 |
Collected over October 2006 to May 2010. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 1: Hydrosalpinx Needle Aspiration | — | 0/54 (0%) | 0/54 (0%) |
| 2. no Aspiration | — | 0/53 (0%) | 0/53 (0%) |
| Event | 1: Hydrosalpinx Needle Aspiration | 2. no Aspiration |
|---|---|---|
| Flaring of pelvic infection and peritonitisReproductive system and breast disorders | 0/54 | 0/53 |
| Event | 1: Hydrosalpinx Needle Aspiration | 2. no Aspiration |
|---|---|---|
| Ovarian hyperstimulation syndromeReproductive system and breast disorders | 0/54 | 0/53 |
| Age, Categorical(Participants) | 1: Hydrosalpinx Needle Aspiration | 2. no Aspiration | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 55 | 55 | 110 |
| >=65 years | 0 | 0 | 0 |
| Age Continuous(years) | 1: Hydrosalpinx Needle Aspiration | 2. no Aspiration | Total |
|---|---|---|---|
| Mean | 28.16 ± 3.6 | 29.38 ± 4.0 | 28.77 ± 3.86 |
| Sex: Female, Male(Participants) | 1: Hydrosalpinx Needle Aspiration | 2. no Aspiration | Total |
|---|---|---|---|
| Female | 55 | 55 | 110 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | 1: Hydrosalpinx Needle Aspiration | 2. no Aspiration | Total |
|---|---|---|---|
| Egypt | 55 | 55 | 110 |
The record gives a start of Oct 2006, a primary completion of Feb 2010 and a completion of May 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2011, 1 year 6 months after primary completion.
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This study is completed, as verified in Oct 2010. You cannot join it, but the record below documents what was studied.
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