The Value of HBA in the Evaluation of Idiopathic Infertility

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Other: HBA binding assay

• Registration Number: NCT01683435
• Lead Sponsor: 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

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 Timeline

• Study Start: 2011-11
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Study First Submitted: 2012-09-07
• Study First Submitted QC: 2012-09-07
• Study First Posted: 2012-09-11
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-31
• Last Update Posted: 2015-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

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Exclusion Criteria

• women over 40, prior failed IVF

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
hylauronin binding assay	HBA binding assay	HBA binding assay will be preformed on the discarded portion of semen analysis used for IVF.

Primary Outcome Measures

Name	Time	Method
In each of these groups we will assess presence of HBA bound sperm	immediate at time of preforming HBA test

Trial Locations

Locations (1)

The Continuum Reproductive Center; 🇺🇸 New York, New York, United States