The Value of Hyaluronic Binding Assays (HBA) in the Evaluation of Idiopathic Infertility
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- In each of these groups we will assess presence of HBA bound sperm
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
hylauronin binding assay
HBA binding assay will be preformed on the discarded portion of semen analysis used for IVF.
Intervention: HBA binding assay (Other)
Outcomes
Primary Outcomes
In each of these groups we will assess presence of HBA bound sperm
Time Frame: immediate at time of preforming HBA test
Secondary Outcomes
No secondary outcomes reported