Table 3 Characteristics of studies assessing the clinical utility of LH-activity containing gonadotropins for males with idiopathic oligozoospermia
From: The role of luteinizing hormone activity in spermatogenesis: from physiology to clinical practice
Study | Study design | Country | Study population | Mean age (SD or range) | Intervention regimen | Mean Tx period | Control group | Semen parameters outcomes | Pregnancy outcomes | Adverse events |
|---|---|---|---|---|---|---|---|---|---|---|
Andrabi et al. (2022) [27] | CS | India | N = 56 Hypogonadal patients (TT < 400 ng/dL) with idiopathic severe O (< 5 million/mL) | ▪ Responder group: 32.0 (4.3) Non-responder group: 30.4 (3.3) | rhCG 1 × /wk | 6 mo | No | Improvement in sperm concentration and TSC; motility unchanged | NR | NR |
Schill et al. (1982) [28] | RC | Germany | N = 48 NG (FSH levels < 3.5 ng/mL; TT > 3.0 ng/mL) with idiopathic O (< 20 million/mL) ▪ Group A (n = 9): sperm concentration 1–5 million/mL ▪ Group B (n = 12): 5.1–10 million/mL ▪ Group C (n = 18): 10.1–15 million/mL Group D (n = 9): 15.1–20 million/mL | 34.4 ▪ (5.0) | hMG 75 IU 3 × /wk + uhCG 2500 IU 2 × /wk | 3 mo | No | Increased sperm concentration, TSC and progressive motility; morphology unchanged | Data of 33 patients available; natural pregnancies ≤ 1 y after initiation of treatment ▪ Overall PR: 10/33 (30.3%) ▪ Group A: 4/7 (57.1%) ▪ Group B: 1/7 (14.3%) ▪ Group C: 5/12 (41.7%) ▪ Group D: 0/7 (0%) | NR |
Knuth et al. (1987) [29] | RCT | Germany | N = 37 NG (hormonal profile not specified) with idiopathic O (< 10 million/mL) ▪ IG: n = 17 ▪ CG: n = 20 | ▪ IG: 31.1 (3.6) ▪ CG: 33.2 (6.5) | hMG 150 IU 3 × /wk + uhCG 2500 IU 2 × /wk | 13 wk | Yes | No difference in sperm concentration and motility between groups | ▪ IG: 2/17 (11.7%) ▪ CG: 0/20 (0%) | Breast tenderness and gynecomastia (1 case) |
Foresta et al. (2009) [30] | RCT | Italy | N = 87 HG (FSH threshold not specified) with idiopathic and non-idiopathic severe O (< 3 million/mL) and testicular histopathology showing HYPO ▪ IG: n = 57 ▪ CG: n = 30 | 34.2 (4.5) | Leuprolide acetate 3.75 mg 1 dose, and after 30 d, leuprolide acetate 3.75 mg 1 × /mo + rFSH 150 IU every 2 d + hCG 2000 IU (type not specified) 2 × /wk | 3 mo | Yes | Increased sperm concentration and morphology in treatment group vs control group, but motility unchanged | Natural pregnancy: ▪ IG: 4/57 (7%) ▪ CG: 0/30 (0%) ART: ▪ IG: IVF 6/21 (28.6%) ▪ ICSI: 8/32 (25.0%) ▪ CG: only ICSI 6/30 (20.0%) Total PR: ▪ IG: 18/57 (31.6%) ▪ CG: 6/30 (20.0%) | 10 patients experienced AEs related to androgen deprivation (asthenia, hot flushes, headache) that disappeared after hCG administration |
La Vignera et al. (2020) [31] | CS | Italy | N = 210 NG or hypogonadal (TT < 350 ng/dL) with OA (< 15illion/mL) | 30.7 | Various regimens including: ▪ Group A (n = 40; TV > 12 mL + TT > 350 ng/dL): FSH 150 IU (type not specified) 3 × /wk for ≥ 3 mo ▪ (ii) Group B (n = 60; TV > 12 mL + TT < 350 ng/dL): hCG 2000 IU (type not specified) 2 × /wk for 3 mo; if no sperm parameters improvement, then FSH added for 3 mo; if TT remained low, then hCG continued for another 3 mo; if TT normalized, hCG suspended ▪ Group C (n = 65; TV < 12 mL + TT < 50 ng/dL): FSH 150 IU (type not specified) 3 × /wk + hCG 2000 IU (type not specified) 2 × /wk ▪ Group D (n = 45; TV < 12 mL + TT > 350 ng/dL): FSH 150 IU (type not specified) 3 × /wk for 3 mo, if TV increased, but no improvement in sperm parameters, hCG 2000 IU added (type not specified) 1 × /wk for 3 mo; if TV and sperm parameters unchanged, FSH continued for another 3 mo | 3–6 mo | No | Improvement in parameters and decreased sperm DNA fragmentation rates | Natural pregnancy: ▪ Group A: 15/60 (25%) ▪ Group B: 12/40 (30%) ▪ Group C: 20/65 (31%) ▪ Group D: 15/45 (33%) | NR |