InfertilityPhase 2NCT00566956
Ultrasound-guided Hydrosalpinx Aspiration During Egg Collection
A Phase 2 study testing Hydrosalpinx needle aspiration to arm 1 in people with Infertility, run by Birmingham Women's NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
· What we know: Hydrosalpinx and IVF About 40% of patients undergoing IVF have tubal disease and in 25%-30% of tubal disease patients there is fluid collection within the tube; hydrosalpinx. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Hydrosalpinx needle aspiration to arm 1
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 1999to Jun 2004
- 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 20 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy women, ASA class 1 (normal healthy) or class 2 (with mild systemic disease);
- undergoing IVF or ICSI and reaching the stage of egg collection;
- with ultrasonically diagnosed hydrosalpinx and identifiable during the phase of ovarian stimulation;
- giving written informed consent.
Who cannot join
- patients not giving written informed consent;
- patients cancelled for poor ovarian response;
- ultrasonically diagnosed hydrosalpinx and identifiable for the first time at egg-collection
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Assisted Conception Unit, Birmingham Women's Hospital, Birmingham University
Birmingham, B15 2TG
About this study
Official title: Ultrasound-guided Hydrosalpinx Aspiration During Egg Collection Improves Pregnancy Outcome in In-vitro Fertilization: a Randomised Controlled Trial
- What we know: Hydrosalpinx and IVF About 40% of patients undergoing IVF have tubal disease and in 25%-30% of tubal disease patients there is fluid collection within the tube; hydrosalpinx. The amount of fluid in the hydrosalpinx is known to increase with ovarian stimulation (as in IVF) and often empties into the uterine cavity. Fluid from hydrosalpinges has been found to be detrimental to the growth and development of mouse embryos in vitro, and associated with reduced levels of endometrial integrins in vivo. This could be the explanation of the reduced pregnancy rates after IVF in patients with tubal disease and hydrosalpinx compared with those with tubal disease but no hydrosalpinx. This effect was evidence in both fresh and frozen embryo transfer cycles. Also there was a significant increase in miscarriage in association with hydrosalpinx.
The study aims to answer the question: does ultrasound-guided aspiration of ultrasound diagnosed hydrosalpinx at the time of egg collection improve the pregnancy rate in IVF?
Read the detailed description
- What we do not know: Treatment of hydrosalpinx and IVF Several studies in the literature have suggested that the treatment of hydrosalpinx pre-IVF would improve the pregnancy rate to a level similar to tubal disease patients without hydrosalpinx. The treatment modalities explored were salpingectomy, salpingostomy, tubal occlusion and ultrasound-guided aspiration either one month before or at the time of egg collection. All studies reported to date have been retrospective and with poor control design. A prospective randomised controlled trial is needed. All modalities have been associated with a similar improvement in pregnancy rate, but the least invasive modality is ultrasound-guided aspiration at the time of oocyte collection. We propose to conduct a prospective randomised controlled trial to evaluate the effect of ultrasound-guided aspiration (versus no aspiration) of hydrosalpinx at the time of egg collection on the pregnancy rate in IVF.
- Conditions
- Infertility
- Being tested
- Hydrosalpinx needle aspiration to arm 1
- Keywords
- Hydrosalpinx/IVF/Reproductive outcome., Hydrosalpinx
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrosalpinx needle aspiration to arm 1Procedure or surgery
For those assigned to Group I, the hydrosalpinx will be aspirated after all the eggs have been collected, under GA. Under ultrasound-guidance, the aspiration (egg collection) needle will be inserted into the hydrosalpinx and suction applied until no more fluid is obtained. If there are bilateral hydrosalpinges, the process is repeated on the opposite side. The hydrosalpinx fluid is discarded
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | For those assigned to Group 1, the hydrosalpinx will be aspirated after all the eggs have been collected, under GA. Under ultrasound-guidance, the aspiration (egg collection) needle will be inserted into the hydrosalpinx and suction applied until no more fluid is obtained. If there are bilateral hydrosalpinges, the process is repeated on the opposite side. Receives: Procedure: Hydrosalpinx needle aspiration to arm 1 |
| 2 | No intervention | Patients assigned to group 2 will not have the hydrosalpinx aspirated |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measures were biochemical (urinary hCG test performed 14 days after embryo transfer) and clinical (presence of gestational sac by transvaginal ultrasound scan) pregnancy rates per randomised women.
Measured: 2-4 weeks
Secondary outcomes (1)
Secondary outcome measures were implantation rate, first trimester miscarriages (any pregnancy loss before 12 weeks gestation) and pelvic infection.
Measured: 2-4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2007 (estimated)
- Study startOct 1999
- Study completionJun 2004
Why it stopped: The study was terminated because it is very difficult to recruit more patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Crossover
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Birmingham Women's NHS Foundation Trust
- Sponsor type
- Other government
- Investigators
- Nahed Hammadieh, MD,MRCOG, Principal investigator, Assisted Conception Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00566956
- Sponsor's protocol ID
- 0288
- Other IDs
- CC/APM/DD/C2/05
- Status last verified
- Nov 2007
- First submitted
- 30 Nov 2007
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Strandell 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 10548619Hammadieh 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 18343810
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Hydrosalpinx Aspiration During Egg Collection Improves Pregnancy Outcome in In-vitro Fertilization: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00566956
- Acronym / sponsor ID
- 0288
- Conditions
- Infertility
- Keywords
- Hydrosalpinx/IVF/Reproductive outcome., Hydrosalpinx
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated because it is very difficult to recruit more patients.
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Birmingham Women's NHS Foundation TrustOther government
- Study start
- Oct 1999
- Study completion
- Jun 2004 (actual)
- First posted
- 4 Dec 2007 (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.
- What we know: Hydrosalpinx and IVF About 40% of patients undergoing IVF have tubal disease and in 25%-30% of tubal disease patients there is fluid collection within the tube; hydrosalpinx. The amount of fluid in the hydrosalpinx is known to increase with ovarian stimulation (as in IVF) and often empties into the uterine cavity. Fluid from hydrosalpinges has been found to be detrimental to the growth and development of mouse embryos in vitro, and associated with reduced levels of endometrial integrins in vivo. This could be the explanation of the reduced pregnancy rates after IVF in patients with tubal disease and hydrosalpinx compared with those with tubal disease but no hydrosalpinx. This effect was evidence in both fresh and frozen embryo transfer cycles. Also there was a significant increase in miscarriage in association with hydrosalpinx.
The study aims to answer the question: does ultrasound-guided aspiration of ultrasound diagnosed hydrosalpinx at the time of egg collection improve the pregnancy rate in IVF?
Detailed description
- What we do not know: Treatment of hydrosalpinx and IVF Several studies in the literature have suggested that the treatment of hydrosalpinx pre-IVF would improve the pregnancy rate to a level similar to tubal disease patients without hydrosalpinx. The treatment modalities explored were salpingectomy, salpingostomy, tubal occlusion and ultrasound-guided aspiration either one month before or at the time of egg collection. All studies reported to date have been retrospective and with poor control design. A prospective randomised controlled trial is needed. All modalities have been associated with a similar improvement in pregnancy rate, but the least invasive modality is ultrasound-guided aspiration at the time of oocyte collection. We propose to conduct a prospective randomised controlled trial to evaluate the effect of ultrasound-guided aspiration (versus no aspiration) of hydrosalpinx at the time of egg collection on the pregnancy rate in IVF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Hydrosalpinx needle aspiration to arm 1For those assigned to Group 1, the hydrosalpinx will be aspirated after all the eggs have been collected, under GA. Under ultrasound-guidance, the aspiration (egg collection) needle will be inserted into the hydrosalpinx and suction applied until no more fluid is obtained. If there are bilateral hydrosalpinges, the process is repeated on the opposite side. |
| 2 | No intervention | –Patients assigned to group 2 will not have the hydrosalpinx aspirated |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy women, ASA class 1 (normal healthy) or class 2 (with mild systemic disease);
- undergoing IVF or ICSI and reaching the stage of egg collection;
- with ultrasonically diagnosed hydrosalpinx and identifiable during the phase of ovarian stimulation;
- giving written informed consent.
Key exclusion criteria (3 listed)
- patients not giving written informed consent;
- patients cancelled for poor ovarian response;
- ultrasonically diagnosed hydrosalpinx and identifiable for the first time at egg-collection
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 |
|---|---|---|
| Hydrosalpinx needle aspiration to arm 1For those assigned to Group I, the hydrosalpinx will be aspirated after all the eggs have been collected, under GA. Under ultrasound-guidance, the aspiration (egg collection) needle will be inserted into the hydrosalpinx and suction applied until no more fluid is obtained. If there are bilateral hydrosalpinges, the process is repeated on the opposite side. The hydrosalpinx fluid is discarded | Procedure or surgery | 1 |
Primary outcome
The primary outcome measures were biochemical (urinary hCG test performed 14 days after embryo transfer) and clinical (presence of gestational sac by transvaginal ultrasound scan) pregnancy rates per randomised women.
Time frame: 2-4 weeks
1 secondary outcome
Secondary outcome measures were implantation rate, first trimester miscarriages (any pregnancy loss before 12 weeks gestation) and pelvic infection.
Time frame: 2-4 weeks
Results and safety
The study was stopped early (reason given: The study was terminated because it is very difficult to recruit more patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
- Results publication: 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 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.
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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.
Nahed Hammadieh, MD,MRCOG principal investigator
Assisted Conception Unit
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 Hydrosalpinx needle aspiration to arm 1 in people with Infertility, run by Birmingham Women's NHS Foundation Trust at 1 site in United Kingdom.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 21 Jul 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 United Kingdom. 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 was stopped early (reason given: The study was terminated because it is very difficult to recruit more patients.). Results are not available in the source record.
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 primary outcome measures were biochemical (urinary hCG test performed 14 days after embryo transfer) and clinical (presence of gestational sac by transvaginal ultrasound scan) pregnancy rates per randomised women. (time frame: 2-4 weeks). 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 NCT00566956, 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 21 Jul 2015.