InfertilityPhase 2NCT02008240
Salpingectomy Versus Aspiration of Hydrosalpingeal Fluid Prior to IVF-ET
A Phase 2 study testing Needle aspiration of hydrosalpinx and Salpingectomy in people with Infertility, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
The aim of this randomized controlled trial is to compare the efficacy of ultrasound guided aspiration of hydrosalpingeal fluid with salpingectomy in the management patients with ultrasound visible hydrosalpinges undergoing 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?
- Needle aspiration of hydrosalpinx and Salpingectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2011to May 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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.
About this study
Official title: Salpingectomy Versus Aspiration of Hydrosalpingeal Fluid Prior to IVF-ET.A Randomized Controlled Trial
The aim of this randomized controlled trial is to compare the efficacy of ultrasound guided aspiration of hydrosalpingeal fluid with salpingectomy in the management patients with ultrasound visible hydrosalpinges undergoing IVF-ET.
Read the detailed description
The adverse impact of hydrosalpinx on in vitro fertilisation embryo transfer (IVF-ET) outcomes has been confirmed by several retrospective and prospective studies .
Cochrane review of prospective randomised 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 or previous multiple laparotomies. Furthermore, many infertile couples refuse to undergo bilateral salpingectomy or proximal tubal occlusion because these procedures remove any hope of spontaneous pregnancy. Other less invasive options for patients with hydrosalpinges as ultrasound-guided aspiration of hydrosalpingeal fluid, antibiotics (alone or combined with aspiration) 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 because most of the supporting evidences for these methods come from small retrospective studies.
A recent randomized controlled trial revealed that the aspiration of hydrosalpingeal fluid at the time of oocyte retrieval was associated with improved implantation rate and pregnancy rates.
The aim of this randomized controlled trial is to compare the efficacy of ultrasound guided aspiration of hydrosalpingeal fluid with salpingectomy in the management patients with ultrasound visible hydrosalpinges undergoing IVF-ET
- Conditions
- Infertility
- Being tested
- Needle aspiration of hydrosalpinx, Salpingectomy
- Keywords
- Infertility, Hydrosalpinx, IVF-ET, Salpingectomy
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needle aspiration of hydrosalpinxProcedure or surgery
Also called ultrasound guidance 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.
SalpingectomyProcedure or surgery
Also called surgical removal of hydrosalpinx
laparoscopic surgical removal of affected tube is done with bipolar electrocoagulation for hemostasis. The mesosalpinx is coagulated as close a possible to the fallopian tube to avoid any compromise in the ovarian blood supply . In cases with marked adhesion, proximal ligation and a distal fenestration is done .
| Study group | Role | What they receive |
|---|---|---|
| Needle aspiration of hydrosalpinx | Experimental | Aspiration of hydrosalpingeal fluid under ultrasound guidance Receives: Procedure: Needle aspiration of hydrosalpinx |
| salpingectomy | Active comparator | Surgical removal of hydrosalpinx Receives: Procedure: Salpingectomy |
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
Measured: 5 weeks after embryo transfer
Secondary outcomes (1)
The Number of Participants Who Achieved Ongoing Pregnancy 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 posted11 Dec 2013 (estimated)
- Study startAug 2011
- Primary completionFeb 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- 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
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof .Usama M.Fouda, Aljazeera Hospital
- Investigators
- Usama M. Fouda, M.D, PhD, Study chair, Assistant professor of Obstetrics and Gynecology , Faculty of medicine ,Cairo university , and scientific director of assisted conception unit, Aljazeera (Al Gazeera) hospital.Ahmed M. Sayed, M.D, PhD, Study director, Assistant professor of Obstetrics and Gynecology , Faculty of medicine ,Cairo university, and clinical director of assisted conception unit, Aljazeera (Al Gazeera) hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008240
- Sponsor's protocol ID
- Hydrosalpinx2
- Status last verified
- Feb 2015
- First submitted
- 8 Dec 2013
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 20672903Strandell A, Lindhard A, Waldenstrom U, Thorburn J, Janson PO, Hamberger L. Hydrosalpinx and IVF outcome: a prospective, randomized multicentre trial in Scandinavia on salpingectomy prior to IVF. Hum Reprod. 1999 Nov;14(11):2762-9. doi: 10.1093/humrep/14.11.2762.
PubMed 10548619Fouda UM, Sayed AM, Abdelmoty HI, Elsetohy KA. Ultrasound guided aspiration of hydrosalpinx fluid versus salpingectomy in the management of patients with ultrasound visible hydrosalpinx undergoing IVF-ET: a randomized controlled trial. BMC Womens Health. 2015;15:21. doi: 10.1186/s12905-015-0177-2. Epub 2015 Feb 27.
PubMed 25783650
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Salpingectomy Versus Aspiration of Hydrosalpingeal Fluid Prior to IVF-ET.A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02008240
- Acronym / sponsor ID
- Hydrosalpinx2
- Conditions
- Infertility
- Keywords
- Infertility, Hydrosalpinx, IVF-ET, Salpingectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
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 randomized controlled trial is to compare the efficacy of ultrasound guided aspiration of hydrosalpingeal fluid with salpingectomy in the management patients with ultrasound visible hydrosalpinges undergoing IVF-ET.
Detailed description
The adverse impact of hydrosalpinx on in vitro fertilisation embryo transfer (IVF-ET) outcomes has been confirmed by several retrospective and prospective studies .
Cochrane review of prospective randomised 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 or previous multiple laparotomies. Furthermore, many infertile couples refuse to undergo bilateral salpingectomy or proximal tubal occlusion because these procedures remove any hope of spontaneous pregnancy. Other less invasive options for patients with hydrosalpinges as ultrasound-guided aspiration of hydrosalpingeal fluid, antibiotics (alone or combined with aspiration) 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 because most of the supporting evidences for these methods come from small retrospective studies.
A recent randomized controlled trial revealed that the aspiration of hydrosalpingeal fluid at the time of oocyte retrieval was associated with improved implantation rate and pregnancy rates.
The aim of this randomized controlled trial is to compare the efficacy of ultrasound guided aspiration of hydrosalpingeal fluid with salpingectomy in the management patients with ultrasound visible hydrosalpinges undergoing IVF-ET
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Needle aspiration of hydrosalpinx | Experimental | Procedure: Needle aspiration of hydrosalpinxAspiration of hydrosalpingeal fluid under ultrasound guidance |
| salpingectomy | Active comparator | Procedure: SalpingectomySurgical removal of hydrosalpinx |
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 (6 listed)
- Uterine fibroid requiring surgical removal.
- Endometriosis.
- Male factor of infertility requiring ICSI, Previous IVF cycles.
- History of recurrent miscarriage.
- Endocrinologic disorders.
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 |
|---|---|---|
| Needle aspiration of hydrosalpinxAlso: ultrasound guidance aspiration of hydrosalpingeal fluidUnder 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 | Needle aspiration of hydrosalpinx |
| SalpingectomyAlso: surgical removal of hydrosalpinxlaparoscopic surgical removal of affected tube is done with bipolar electrocoagulation for hemostasis. The mesosalpinx is coagulated as close a possible to the fallopian tube to avoid any compromise in the ovarian blood supply . In cases with marked adhesion, proximal ligation and a distal fenestration is done . | Procedure or surgery | salpingectomy |
Primary outcome
The Number of Participants Who Achieved Clinical Pregnancy in a Transfer Cycle
Time frame: 5 weeks after embryo transfer
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
- Background: 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.
- Background: PubMed 10548619Strandell A, Lindhard A, Waldenstrom U, Thorburn J, Janson PO, Hamberger L. Hydrosalpinx and IVF outcome: a prospective, randomized multicentre trial in Scandinavia on salpingectomy prior to IVF. Hum Reprod. 1999 Nov;14(11):2762-9. doi: 10.1093/humrep/14.11.2762.
- Derived from this study: PubMed 25783650Fouda UM, Sayed AM, Abdelmoty HI, Elsetohy KA. Ultrasound guided aspiration of hydrosalpinx fluid versus salpingectomy in the management of patients with ultrasound visible hydrosalpinx undergoing IVF-ET: a randomized controlled trial. BMC Womens Health. 2015;15:21. doi: 10.1186/s12905-015-0177-2. Epub 2015 Feb 27.
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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
Assistant professor of Obstetrics and Gynecology , Faculty of medicine ,Cairo university , and scientific director of assisted conception unit, Aljazeera (Al Gazeera) hospital.
Ahmed M. Sayed, M.D, PhD study director
Assistant professor of Obstetrics and Gynecology , Faculty of medicine ,Cairo university, and clinical director of assisted conception unit, Aljazeera (Al Gazeera) hospital
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 Needle aspiration of hydrosalpinx and Salpingectomy in people with Infertility, run by Aljazeera Hospital 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 6 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 18 Feb 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 NCT02008240, which also lists 3 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 18 Feb 2015.