Back to resultsThe Value of HBA in the Evaluation of Idiopathic Infertility
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HBA binding assay
Sponsored by
About this trial
This is an interventional diagnostic trial for Infertility
Eligibility Criteria
Inclusion Criteria:
. 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
Exclusion Criteria:
- women over 40, prior failed IVF
Sites / Locations
- The Continuum Reproductive Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
hylauronin binding assay
Arm Description
HBA binding assay will be preformed on the discarded portion of semen analysis used for IVF.
Outcomes
Primary Outcome Measures
In each of these groups we will assess presence of HBA bound sperm
Secondary Outcome Measures
Full Information
NCT ID
NCT01683435
First Posted
September 7, 2012
Last Updated
August 31, 2015
Sponsor
St. Luke's-Roosevelt Hospital Center
1. Study Identification
Unique Protocol Identification Number
NCT01683435
Brief Title
The Value of HBA in the Evaluation of Idiopathic Infertility
Official Title
The Value of Hyaluronic Binding Assays (HBA) in the Evaluation of Idiopathic Infertility
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Luke's-Roosevelt Hospital Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
hylauronin binding assay
Arm Type
Experimental
Arm Description
HBA binding assay will be preformed on the discarded portion of semen analysis used for IVF.
Intervention Type
Other
Intervention Name(s)
HBA binding assay
Intervention Description
HBA binding assay will be preformed on the discarded portion of semen analysis used for IVF.
Primary Outcome Measure Information:
Title
In each of these groups we will assess presence of HBA bound sperm
Time Frame
immediate at time of preforming HBA test
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
. 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
Exclusion Criteria:
women over 40, prior failed IVF
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Keltz, MD
Organizational Affiliation
Mount Sinai St. Luke's
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Continuum Reproductive Center
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Value of HBA in the Evaluation of Idiopathic Infertility
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