InfertilityPhase 2NCT01040351
Ultrasound Guided Aspiration of Hydrosalpingeal Fluid and IVF-ET Outcomes
A Phase 2 study testing ultrasound guided aspiration of hydrosalpingeal fluid in people with Infertility, run by Cairo University at 1 site in Egypt.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- ultrasound guided aspiration of hydrosalpingeal fluid
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2006to May 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with unilateral or bilateral hydrosalpinges visible by ultrasound
- Age between 18 - 37 years
- Period of infertility > 1 year
- Body mass index between 19-29
- Normal basal luteinizing hormone (LH), follicle stimulating hormone (FSH) and prolactin concentrations
- Normal recent semen analysis (according to World Health Organization criteria)
Who cannot join
- Uterine fibroid requiring surgical removal
- Endometriosis
- Male factor of infertility requiring ICSI
- Previous IVF cycles
- History of recurrent miscarriage
- Endocrinologic disorders
- Presence of systemic disease contraindicating pregnancy
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Ahmed Elgazzar hospital , Assisted conception unit
Giza, 35 Eleshreen Saint King Faisal., 12111
About this study
Official title: Effect of Ultrasound Guided Aspiration of Hydrosalpingeal Fluid at the Time of Oocyte Retrieval on the Outcomes of IVF-ET, a Randomized Controlled Trial
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 .
Read the detailed description
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 .
- Conditions
- Infertility
- Being tested
- ultrasound guided aspiration of hydrosalpingeal fluid
- Keywords
- Infertility, Hydrosalpinx, IVF-ET
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided aspiration of hydrosalpingeal fluidProcedure or surgery
Also called ultrasound guided Hydrosalpinx needle aspiration
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: Procedure: ultrasound guided aspiration of hydrosalpingeal fluid |
| 2. no aspiration | No intervention | IVF-ET is done without prior aspiration of hydrosalpingeal fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 weeks after embryo transfer
Secondary outcomes (1)
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 .
Measured: 18 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2009 (estimated)
- Study startOct 2006
- Primary completionFeb 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Ahmed Elgazzar Hospital
- Investigators
- Usama M Fouda, M.D, PhD, Study chair, Lecturer of obstetrics and Gynecology , Faculty of medicine ,Cairo university.Ahmed M sayed, MD,PhD, Study director, Assistant professor of obstetrics and Gynecology , Faculty of medicine ,Cairo university.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01040351
- Sponsor's protocol ID
- hydrosalpinx1
- Status last verified
- Oct 2010
- First submitted
- 28 Dec 2009
- Last updated
- 29 Aug 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 18343810Fouda 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.
PubMed 20672903
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ultrasound Guided Aspiration of Hydrosalpingeal Fluid at the Time of Oocyte Retrieval on the Outcomes of IVF-ET, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01040351
- Acronym / sponsor ID
- hydrosalpinx1
- Conditions
- Infertility
- Keywords
- Infertility, Hydrosalpinx, IVF-ET
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Ahmed Elgazzar Hospital
- Study start
- Oct 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 29 Dec 2009 (estimated)
- Results
- Posted 29 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed description
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: Hydrosalpinx needle aspiration | Experimental | Procedure: ultrasound guided aspiration of hydrosalpingeal fluidAfter 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 |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients with unilateral or bilateral hydrosalpinges visible by ultrasound
- Age between 18 - 37 years
- Period of infertility > 1 year
- Body mass index between 19-29
- Normal basal luteinizing hormone (LH), follicle stimulating hormone (FSH) and prolactin concentrations
Key exclusion criteria (7 listed)
- Uterine fibroid requiring surgical removal
- Endometriosis
- Male factor of infertility requiring ICSI
- Previous IVF cycles
- History of recurrent miscarriage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ultrasound guided aspiration of hydrosalpingeal fluidAlso: ultrasound guided Hydrosalpinx needle aspirationUnder 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. | Procedure or surgery | 1: Hydrosalpinx needle aspiration |
Primary outcome
The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle
Time frame: 5 weeks after embryo transfer
The Number of Participants Who Achieved Clinical Pregnancy( presence of intrauterine gestational sac detected by transvaginal ultrasound )in a transfer cycle
1 secondary outcome
The Number of Participants Who Achieved Ongoing Pregnancy in a Transfer Cycle .
Time frame: 18 weeks after embryo transfer
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18343810Hammadieh 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.
- Derived from this study: PubMed 20672903Fouda 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Usama M Fouda, M.D, PhD study chair
Lecturer of obstetrics and Gynecology , Faculty of medicine ,Cairo university.
Ahmed M sayed, MD,PhD study director
Assistant professor of obstetrics and Gynecology , Faculty of medicine ,Cairo university.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ultrasound guided aspiration of hydrosalpingeal fluid in people with Infertility, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle (time frame: 5 weeks after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01040351, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2011; AzTrials last refreshed its copy on 8 Nov 2026.