Abortion, Habitual, Male Infertility, Unexplained Infertility
Conditions
Keywords
sperm DNA integrity, Toluidine blue assay (TBA), IVF outcome
Brief summary
Sperm DNA integrity will be measured via the Toluidine Blue Assay (TBA) for patients undergoing In Vitro Fertilization (IVF); the study will determine correlations, if any, between IVF success and sperm DNA integrity.
Interventions
None listed
Sponsors
Northwell Health
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* couple undergoing IVF at the Center for Human Reproduction * sperm sample given from partner (not a donor)
Exclusion criteria
* low sperm concentration (\<5 million/cc) * using a donor sample
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy | 9 months | detemining whether the sperm sample (tested for DNA integrity) used to insemenate IVF retrieved eggs, results in a live birth |
Countries
United States
Participant flow
Recruitment details
Recruitment occured at the Center for Human Reproduction under an IRB waiver of informed consent for participation.
Participants by arm
| Arm | Count |
|---|---|
| IVF Cycles those individuals undergoing conventional IVF to inseminate their retrieved eggs | 337 |
| ICSI those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI) | 402 |
| Total | 739 |
Baseline characteristics
| Characteristic | ICSI | IVF Cycles | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 402 Participants | 337 Participants | 739 Participants |
| Age, Continuous | 34.9 years STANDARD_DEVIATION 2.5 | 34.7 years STANDARD_DEVIATION 2.6 | 34.8 years STANDARD_DEVIATION 2.6 |
| Region of Enrollment United States | 402 participants | 337 participants | 739 participants |
| Sex: Female, Male Female | 402 Participants | 337 Participants | 739 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Pregnancy
detemining whether the sperm sample (tested for DNA integrity) used to insemenate IVF retrieved eggs, results in a live birth
Time frame: 9 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IVF Cycles | Pregnancy | 67 participants |
| ICSI | Pregnancy | 80 participants |