Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Value of HBA in the Evaluation of Idiopathic Infertility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01683435
Recruitment Status : Completed
First Posted : September 11, 2012
Last Update Posted : September 2, 2015
Sponsor:
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

Tracking Information
First Submitted Date  ICMJE September 7, 2012
First Posted Date  ICMJE September 11, 2012
Last Update Posted Date September 2, 2015
Study Start Date  ICMJE November 2011
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2012)
In each of these groups we will assess presence of HBA bound sperm [ Time Frame: immediate at time of preforming HBA test ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Value of HBA in the Evaluation of Idiopathic Infertility
Official Title  ICMJE The Value of Hyaluronic Binding Assays (HBA) in the Evaluation of Idiopathic Infertility
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Infertility
Intervention  ICMJE Other: HBA binding assay
HBA binding assay will be preformed on the discarded portion of semen analysis used for IVF.
Study Arms  ICMJE Experimental: hylauronin binding assay
HBA binding assay will be preformed on the discarded portion of semen analysis used for IVF.
Intervention: Other: HBA binding assay
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 31, 2015)
35
Original Estimated Enrollment  ICMJE
 (submitted: September 7, 2012)
80
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • . All groups will include females under 40 years of age undergoing 1st IVF cycle 3 groups

    1. 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
    2. 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
    3. Tubal infertility as assessed by HSG or laparoscopy

Exclusion Criteria:

  • women over 40, prior failed IVF
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01683435
Other Study ID Numbers  ICMJE IRB 11-134
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party St. Luke's-Roosevelt Hospital Center
Study Sponsor  ICMJE St. Luke's-Roosevelt Hospital Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Martin Keltz, MD Mount Sinai St. Luke's
PRS Account St. Luke's-Roosevelt Hospital Center
Verification Date August 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP