Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Yale University
With
University of North Carolina
Augusta University
Penn State University
University of California, San Francisco
University of Oklahoma
University of Pennsylvania
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
12 or more months of infertility (primary or secondary)
Heterosexual
Cohabitating and able to have regular intercourse
Male:
≥ 18 years of age
At least one abnormal semen parameter on a semen analysis within the past 6 months:
* Sperm concentration ≤15 Million/ml
* Total motility ≤40%
* Normal morphology (Kruger) ≤4%
* DNA fragmentation (SCSA, DNA fragmentation index) \>25%
Female:
≥18 years of age and ≤40 years of age
For women ≥ 35 years of age, evidence of normal ovarian reserve as assessed by menstrual cycle day 3 (+/-2 days) FSH ≤10 IU/L with estradiol ≤ 70 pg/mL, AMH ≥ 1.0 ng/mL, OR antral follicle count \>10 within one year prior to study initiation.
Evidence of at least one patent fallopian tube as determined by an hysterosalpingogram or laparoscopy showing at least one patent fallopian tube or a saline infusion sonogram showing spillage of contrast material
Regular cycles defined as ≥25 days and ≤35 days in duration
Evidence of ovulation including biphasic basal body temperatures, positive ovulation predictor kits, or progesterone level ≥3 ng/ml.
You may not be if
Couple:
* Previous sterilization procedures (vasectomy, tubal ligation). The prior procedure may affect study outcomes.
* Planning in vitro fertilization in the next 6 months
Male:
Sperm concentration \< 5 million/mL on screening semen analysis
Current use of a medication or drug that would affect reproductive function or metabolism (see Appendix C for list)
Current multivitamin or herb use (requires 1 month wash-out)
Current serious medical illnesses, such as cancer, heart disease, or cirrhosis
Current use of anticoagulants
Untreated hypothyroidism
Uncontrolled diabetes mellitus
Female:
History of surgically or medically confirmed moderate or severe endometriosis
Body mass index \>35 kg/m2
Currently pregnant
History of polycystic ovarian syndrome
Current serious medical illnesses, such as cancer, heart disease, or cirrhosis
History of systemic chemotherapy or pelvic radiation
Current use of a medication or drug that would affect reproductive function or metabolism
Clareo Health | Males, Antioxidants, and Infertility Trial
