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The Value of HBA in the Evaluation of Idiopathic Infertility

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01683435
First Posted: September 11, 2012
Last Update Posted: September 2, 2015
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.
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
  Purpose
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 Intervention
Infertility Other: HBA binding assay

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by St. Luke's-Roosevelt Hospital Center:

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

Enrollment: 35
Study Start Date: November 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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
  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
  More Information

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01683435     History of Changes
Other Study ID Numbers: IRB 11-134
First Submitted: September 7, 2012
First Posted: September 11, 2012
Last Update Posted: September 2, 2015
Last Verified: August 2015

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


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