The effect of PDE5 inhibitor on human sperm (PEOS study)

JRCT ID: jRCTs041210135

Registered date:27/01/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: oligospermia, Asthesospermia, sperm shape abnormality, white blood cells in sperm
• Date of first enrollment: 27/01/2022
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Oral administartion (Tadalafil 1 tablet after morning meal for 24 weeks)

Outcome(s)

• Primary Outcome: 20% improvement of sperm findings (sperm concentration) on 12 weeks after oral administration

Secondary Outcome

20 % or 50% improvement of sperm findings (sperm concentration or volume) on 6, 24, or 48 weeks after oral administration, 20 % improvement of sperm findings (sperm
volume) on 12 weeks after oral administration, 50 % improvement of sperm findings
(sperm concentration or volume) on 12 weeks after oral administration,adverse event, sperm motility rate, the changes of sperm motility pattern, rate of abnormality of sperm shape, the number of white blood cells in sperm, DNA fragmentation of sperm, sperm
volume, sperm concentration, rate of pregnancy, rate of acqisition of fertilized egg, 20 % improvement defined as below (each week time point) - (time of registration)/(time of registration >20%.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 50age old
• Gender: Male

Include criteria

1) Patients complained infertility and diagnosed as oligospermia, asthenozoospermia.
normal range of human spermia in the institute (sperm volume > 2.0ml, sperm concentration >7500 x 10 5/ml, sperm motility >50.0%, sperm shape abnormality >50.0%, motility level A-C: A: proceed straightly quickly, B: proceed not straightly slowly, C: head or tail movement observed but not proceed), whuite blood cell <100 x10 5/ml, 2)male, 3) age 20 to 50 y.o.,
4) performance status 0-1, 5) patients who wish to give birth of baby and accept to be treated with fertility treatment, 6) obtained written inoformed
consent.

Exclude criteria

1) Patients who use nitric acid drug which is contraindications for concomitant use.
2) Patients who have allergy for Tadalafil.
3) Patients who have past or present history of unstable angina, arrhythmia, hypertention.
4) Patients who have severe liver disease, show more than 100 IU/L of AST(GOT) or ALT(GPT).
5) Patients who have severe kidney disease.
6) Patients involved in another linical trial which started 5 years ago and lasted t3 months and test interventional treatment or target drug or patients who do not have 3 month interval after previous clinical trial.
7) Patients who took supplements that might effect on sperm findings including zinc,
vitamin E, vitamin D, Citrulline, L-arginine, L-carnitine, organic maca, Ginseng, Coenzyme Q10, Yam ingredient, oyster extract, Selnium) except for after 2 weeks of last
administration. Patients who are preffered to taking these ingredients everyday should be excluded. Below is the lists of foods that include standard daily intake of these
ingredients (zinc, vitamin E, vitamin D, Citrulline, L-arginine, L-carnitine, organic maca, Ginseng, Coenzyme Q10, Yam ingredient, oyster extract, Selnium) in 100g.
Zinc (standars daily intake, 10mg for adult male): oyster, wheat germ, salted bonito, paprika, Karasumi, Vitamin E (standars daily intake, 6.5mg for adult male): sencha, sunflower oil, almond, tang Xinzi, wheat germ, matcha, grape oil, safflower oil, rice bran
oil, chrysanthemum paste, sweetfish, soybean germ, hazelnut, corn oil, gyokuro tea,
margarine, the fastsy oil, mayonaise, monkfish, lashes, almond chocholate, peanut,
salmon suzuiko, rice bran, soybean oil, caviar, salmon roe, tang Xinzi, eel, Vitamin D
(standars daily intake, 5.5 mcg for adult male): arage jellyfish, salted bonito, liver of
monkfish, umazurahagi, dried shirasu, sand lance, dried fish seasoned with mirin, sardines, herring, tatami sardine, white salmon roe, filefish, black marlin, arage jellyfish,
grey mullet roe, Pink or humpback salmon, banded blue-sprat, sandeel, frigate tuna,
saury dried with mirin, eel, Citrulline : watermelon, melon, goji berry, cucumber, bitter melon, L-arginine (standars daily intake, 2000mg for adult male): watermelon, peanut,
egg white, L-carnitine(standars daily intake, 1000mg for adult male): lamb, mutton
meat, Coenzyme Q10 (standars daily intake, 100mg for adult male):, it needs 26 of
sardine or 3kg of beef, oyster extract: oyster, Selnium (standars daily intake, 30mcg for adult male): dried bonito, mustard, liver of monkfish, alaska pollack roe, raw bluefin, raw tuna, fried sunflower.

Candidates would be checked if they have these ingredients daily more than 100g. If they had taken them
to some extent or will be given as supplements, candidates should contact to investigator to receive
permission continuing the study.

Patients who had prescription and take midicine shown in below should beexcluded, because the main gredients are each of these supplements.
Pharmaceutical products for each gredients include NOBELZIN, JUVELA, ONEALFA,
ALPHA CALSIDOR, L-CARTIN FF, respectively.
8) Patients who were regarded as disqualified by representative or sharer doctor of
this study.
9) Patients who have been taking PDE5 inhibitor already.
10) Patients who have erectile dysfunction.

Related Information

• Primary Sponsor: Inoue Takahiro