Effect of Graminex on Infertility Related to Male Accessory Glands Inflammation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age20-55
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

Male Accessory Glands Inflammations (MAGI) include inflammatory diseases involving seminal vescicles and the prostate. Patients suffering from them present an impaired fertility because of seminal duct obstruction and alterations of the rheologic and functional parameters of semen, induced by direct microbiological action as well as inflammatory and oxidative damage. Inflammation in seminal plasma can be detected and measured by dosing of inflammatory molecules such as SuPAR and ST2. Treatment of MAGIs include specific antibiotic therapy in addition to use of anti-inflammatory nutraceutics. Deprox HP is a nutraceutic containing GraminexTM, a compound made of pollen extracts of rye, mais and timothy. To investigate its efficacy, we evalued seminal parameters, inflammatory and oxidative molecules in seminal plasma and clinical and ultrasonographic features of male accessory glands before and after 3 months of treatment in 20 patients taking Deprox HP and 20 patients undergoing treatment with palmitoilethanolammide, bromelin and horse chestnut extract.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male patients with a diagnosis of MAGI based on clinical and/or ultrasonographic criteria.

Disqualifiers

History of cryptorchidism, orchitis, testicular torsion or trauma,

Hypogonadism,

Occupational chemical exposure,

Y chromosome microdeletions, karyotype abnormalities and Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) mutations,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Deprox_HP

    Other intervention

    Use of nutraceutic based on a compound of pollen extracts from pollen, mais and timothy

  • Peacist

    Other intervention

    Use of a nutraceutic based on palmitoilethanolamide + Bromelin + Horse Chestunt extract

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Group 1: Deprox HPExperimental treatment 1 intervention
Group B: Group 2: PEA+bromelin+horse chestnut extractActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Modifications of number of spermatozoa

Modifications of the number of spermatozoa in Millions

Time frame
6 months
2

Modification of sperm motility

Modification of sperm progressive motility in %

Time frame
6 months
3

Modifications of number of typical forms

Modifications of number of typical forms in %

Time frame
6 months

Secondary outcomes

1

Modifications of seminal inflammatory parameters

Modifications of seminal inflammatory parameters ST2 and SuPAR, both expressed in ng/mL

Time frame
6 months
2

Modifications of seminal oxidative parameters

Modifications of reactive oxygen species expressed in mEq

Time frame
6 months

Other outcomes

Sponsors and contacts

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