| Table 2. Study characteristics related to number of participants, inclusion and exclusion criteria, type of interventions, type of outcomes, and follow-up. | |||
| Author, year | |||
| Clark & Sherins, 1989 | Gregoriou et al., 2012 | Cavallini, 2013 | |
| Location | Atlanta, USA | Athens, Greece | Andros, Italy |
| No. participants | 25 | 29 | 46 |
|
Inclusion criteria |
Men that were partners in infertile marriages in which there was failure to conceive for at least two years prior to consideration of entry into the protocol | Men with low T/E2 ratio (<10) | Non-smoker non- obstructive azoospermic (NOA) patients who yielded no spermatozoa with fine needle and cryptozoospermic patients with T/E2 ratio < 10 |
|
Exclusion criteria |
Men with known exposure to testicular toxins, including chemotherapeutic agents, radiation, industrial chemicals, pesticides and excessive alcohol intake, and patients with a clinically apparent varicocele, history of cryptorchidism or mumps orchitis, evidence of hypogonadotropic hypogonadism, or a demonstrable chromosomal abnormality. | Not reported | Seminal white blood cell concentration greater than 106 ml and/or a positive seminal cultural analysis or positive urethral swab chlamydia test; drug tobacco, or alcohol abuse; on going medical treatment (gonadotropins, anabolic steroids, cancer chemotherapy, non steroidal anti inflammatory drugs; previous cancer radiotherapy or chemotherapy, palpable varicocele; X-ray exposure in the previous 8 months; Y chromosome microdeletion, and karyotype alterations if Klinefelter syndrome |
|
Type intervention |
Each patient received testolactone 500mg orally four times per day or placebo (gelatin capsules containing cornstarch) for eight months, followed by an alternate therapy for an additional eight months. | Intervention group consisted of 2.5 mg letrozole (n=15) or the control (n=14) groups with 1 mg anastrozole both taken orally once daily | Patients were randomly assigned treatment to receive either letrozole 2.5 mg once a day or placebo (starch 100 mg once a day) |
|
Type of outcomes |
Total estradiol and testosterone levels during testolactone exposure; sex hormone binding globulin (SHBG) capacity and free E2; LH and; FSH serum concentrations | Serum FSH, LH, prolactin (PRL), T, and E2 levels and; total motile sperm count - ejaculate volume x concentration x motile (fraction) | |
|
Follow-up
(months) |
16 | 6 | 8 |