InfertilityNCT01683435
The Value of HBA in the Evaluation of Idiopathic Infertility
A study testing HBA binding assay in people with Infertility, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
We would like to determine if HBA® testing of sperm in couples with presumed idiopathic infertility will reveal lower binding percentages than in couples with an identifiable cause of infertility either male factor or tubal factor Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Infertility
- What is being tested?
- HBA binding assay
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jan 2012
- Phase
- Interventional
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- . All groups will include females under 40 years of age undergoing 1st IVF cycle 3 groups
- Abnormal Semen Analysis (sperm count <10 million/ml and /or rapid progressive motility < 50 %, WHO morphology <30%) normal HSG , normal ovarian reserve testing and ovulation testing
- Unexplained infertility- normal ovarian reserve testing and ovulation testing (FSH< 10, AMH>1.0) Normal ovulatory cycles, normal WHO semen analysis. Normal tubes on HSG or Laparoscopy
- Tubal infertility as assessed by HSG or laparoscopy
Who cannot join
- women over 40, prior failed IVF
Trial locations and contacts
1 site in 1 country.
United States1 site
The Continuum Reproductive Center
New York, New York, 10019
About this study
Official title: The Value of Hyaluronic Binding Assays (HBA) in the Evaluation of Idiopathic Infertility
We would like to determine if HBA® testing of sperm in couples with presumed idiopathic infertility will reveal lower binding percentages than in couples with an identifiable cause of infertility either male factor or tubal factor
Read the detailed description
We would like to determine if HBA® testing of sperm in couples with presumed idiopathic infertility will reveal lower binding percentages than in couples with an identifiable cause of infertility either male factor or tubal factor We would like to determine if patients with abnormal HBA binding have decreased IVF outcome: decreases clinical pregnancy rate, implantation rate, and increased miscarriage rate
- Conditions
- Infertility
- Being tested
- HBA binding assay
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBA binding assayOther
HBA binding assay will be preformed on the discarded portion of semen analysis used for IVF.
| Study group | Role | What they receive |
|---|---|---|
| hylauronin binding assay | Experimental | HBA binding assay will be preformed on the discarded portion of semen analysis used for IVF. Receives: Other: HBA binding assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
In each of these groups we will assess presence of HBA bound sperm
Measured: immediate at time of preforming HBA test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startNov 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Keltz, MD, Principal investigator, Mount Sinai St. Luke's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683435
- Sponsor's protocol ID
- IRB 11-134
- Status last verified
- Aug 2015
- First submitted
- 7 Sep 2012
- Last updated
- 2 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Hyaluronic Binding Assays (HBA) in the Evaluation of Idiopathic Infertility
- ClinicalTrials.gov ID
- NCT01683435
- Acronym / sponsor ID
- IRB 11-134
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 11 Sep 2012 (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.
We would like to determine if HBA® testing of sperm in couples with presumed idiopathic infertility will reveal lower binding percentages than in couples with an identifiable cause of infertility either male factor or tubal factor
Detailed description
We would like to determine if HBA® testing of sperm in couples with presumed idiopathic infertility will reveal lower binding percentages than in couples with an identifiable cause of infertility either male factor or tubal factor We would like to determine if patients with abnormal HBA binding have decreased IVF outcome: decreases clinical pregnancy rate, implantation rate, and increased miscarriage rate
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hylauronin binding assay | Experimental | Other: HBA binding assayHBA binding assay will be preformed on the discarded portion of semen analysis used for IVF. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- . All groups will include females under 40 years of age undergoing 1st IVF cycle 3 groups
Key exclusion criteria (1 listed)
- women over 40, prior failed IVF
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 |
|---|---|---|
| HBA binding assayHBA binding assay will be preformed on the discarded portion of semen analysis used for IVF. | Other | hylauronin binding assay |
Primary outcome
In each of these groups we will assess presence of HBA bound sperm
Time frame: immediate at time of preforming HBA test
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 2 Sep 2015.
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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.
Martin Keltz, MD principal investigator
Mount Sinai St. Luke's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HBA binding assay in people with Infertility, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
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 1 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 2 Sep 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 States. 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.
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?
In each of these groups we will assess presence of HBA bound sperm (time frame: immediate at time of preforming HBA test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2015.