Effect of Medicago sativa seed powder (Plus vitamin E vs. vitamin E alone) on semen analysis in men with idiopathic infertility: A double blind randomized clinical trial.

2024-03
Journal of ethnopharmacology 322
- Azita Sadough Shahmirzadi
- Hamid Shafi
- Hoda Shirafkan
- Zahra Memariani
- Narjes Gorji
- Reihaneh Moeini

PubMed: 38103848
DOI: 10.1016/j.jep.2023.117606

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 60
Population: 60 men with idiopathic infertility
Methods: Randomized clinical trial, 6 g daily M. sativa seed powder or placebo for three months as add-on to vitamin E (100 U)
Duration: 12 weeks
Funding: Unclear

Ethnopharmacological relevance

Different parts of the alfalfa plant (Medicago sativa L.), especially its seeds, have been introduced as a semen quality enhancer in the folk medicine of different regions of Iran as well as in the traditional Persian medicine (PM) books. The seeds of this plant are also used in many combined medicines to treat male infertility in PM.

Aim of the study

This study was designed to investigate the effect of M. sativa seed powder plus vitamin E vs. vitamin E alone on semen analysis of men with idiopathic infertility.

Materials and methods

In this randomized clinical trial, 60 participants were randomly divided into two groups and then received M. sativa seed powder (6 g daily) or placebo for three months, as add-on to vitamin E (100 U). Results of semen analysis (sperm total count, motility, and morphology as well as semen volume) of these two groups and their changes were compared before and after treatment as the primary outcome. The number of pregnancies after one month and probable side effects were also assessed.

Results

After 12 weeks, sperm total count changed from 36.2 ± 21.8 × 10⁶/ml to 48.5 ± 19.1 × 10⁶/ml in M. sativa and from 39.5 ± 23.5 × 10⁶/ml to 41.2 ± 20.9 × 10⁶/ml in placebo, percentage of normal morphology changed from 1.8 ± 0.8% to 2.6 ± 1.2 % in M. sativa and from 2.0 ± 0.9% to 2.6 ± 1.2% in placebo and percentage of motile sperm changed from 36.5 ± 11.8 % to 39.7 ± 12.0% in M. sativa and from 39.3 ± 10.1 % to 38.1 ± 12.1% in placebo. The improvements in M. sativa group are significantly better than placebo group (P = 0.00, 0.01 and 0.04, respectively). However, semen volume decreased in both groups, but its changes were not significant. The number of pregnancies was four in the intervention and zero in placebo group. One case with abdominal bloating and one with respiratory allergy withdrew from the intervention group. No other adverse effect was reported.

Conclusions

In this study, significant improvement was detected in sperm parameters (except semen volume) of men with idiopathic infertility in M. sativa plus vitamin E group in compare to vitamin E alone after 12 weeks. These findings suggest that the M. sativa, as a complementary therapy, may have a beneficial effect on semen quality. More clinical trials with larger sample size are needed.

Research Insights

Vitamin E→Improved Sperm Count
sperm total count changed from ... 39.5 ± 23.5 × 10^6/ml to 41.2 ± 20.9 × 10^6/ml in placebo ... The improvements in M. sativa group are significantly better than placebo group (P = 0.00, 0.01 and 0.04, respectively).
Effect
Neutral
Effect size
Small
Dose
100 U
Vitamin E→Improved Sperm Morphology
percentage of normal morphology changed from ... 2.0 ± 0.9% to 2.6 ± 1.2% in placebo ... The improvements in M. sativa group are significantly better than placebo group (P = 0.00, 0.01 and 0.04, respectively).
Effect
Neutral
Effect size
Small
Dose
100 U
Vitamin E→Improved Sperm Motility
percentage of motile sperm changed from ... 39.3 ± 10.1 % to 38.1 ± 12.1% in placebo ... The improvements in M. sativa group are significantly better than placebo group (P = 0.00, 0.01 and 0.04, respectively).
Effect
Neutral
Effect size
Small
Dose
100 U