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The Value of HBA in the Evaluation of Idiopathic Infertility

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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

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

Condition or disease Intervention/treatment
Infertility Other: HBA binding assay

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 : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Value of Hyaluronic Binding Assays (HBA) in the Evaluation of Idiopathic Infertility
Study Start Date : November 2011
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
U.S. FDA Resources

Arm Intervention/treatment
Experimental: hylauronin binding assay
HBA binding assay will be preformed on the discarded portion of semen analysis used for IVF.
Other: HBA binding assay
HBA binding assay will be preformed on the discarded portion of semen analysis used for IVF.



Primary Outcome Measures :
  1. In each of these groups we will assess presence of HBA bound sperm [ Time Frame: immediate at time of preforming HBA test ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01683435


Locations
United States, New York
The Continuum Reproductive Center
New York, New York, United States, 10019
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Investigators
Principal Investigator: Martin Keltz, MD Mount Sinai St. Luke's

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01683435     History of Changes
Other Study ID Numbers: IRB 11-134
First Posted: September 11, 2012    Key Record Dates
Last Update Posted: September 2, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female