Health Condition 1: N469- Male infertility, unspecified
Conditions
Interventions
None listed
Sponsors
Vilco Laboratories Private limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.History of infertility with current partner at randomisation must be between 12to 60 months if current partner is aged lesser than 35 years 2.Men between the ages of 18 to 45 years. 3.Total sperm count between 1 to 39 million at screening confirmed by two consecutive samples taken greater than or equal to 2 weeks apart before randomization Semen volume greater than or equal to 1.4 mL at screening, confirmed by two consecutive samples taken greater than or equal to 2 weeks apart before randomization. Total sperm motility of greater than or equal to 10 percentage at screening, confirmed by two samples taken greater than or equal to 2 weeks apart before randomization. 4.Agree to have regular intercourse with current female partner with the intent of spontaneous conception within 9 months from randomization. 5.Agree to provide information on female partners positive urine pregnancy test and documentation of ultrasound, delivery, and neonatal or infant health.
Exclusion criteria
Exclusion criteria: 1.Any history of anatomical disorder of the pituitary gland or testes. Any structural abnormalities of the vas deferens (unilateral or bilateral) at screening. 2.Known history of cryptorchidism, testicular torsion, or orchitis. 3.Known abnormal karyotype (including Y chromosome microdeletion). 4.Current or past treatment of urogenital (kidney, bladder, testicular, or prostate) cancer as well as history of chemo- or radiotherapy that can have impact on testes. 5.Any known uncontrolled non-gonadal endocrinopathies (thyroid, adrenal, pituitary disorders). 6.Administration of hormonal preparations, agents known to impair testicular function or affect sex hormone secretion, and known or suspected teratogens within 3 months prior to screening. Administration of anabolic steroids within 12 months prior to screening. 7.History of hypersensitivity to the test product or any ingredients of the products to be used. 8.History of drug or alcohol abuse during the last 6 months. 9.Any known, clinically significant, systemic disease in addition to the trial indication that might negatively impact fertility.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Spontaneous pregnancy observed in female partner within 9 months after randomization of male participants 2.Positive Beta-Human Chorionic Gonadotropins (Beta hCG) (positive urine Beta hCG test) observed in female partner 3.Changes in semen volume 4.Changes in sperm concentration 5.Changes in total sperm count 6.Changes in total motile sperm countTimepoint: 3,6 and 9 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical safety assessments, including weight, blood pressure, pulse and adverse events [ Time Frame: 1,3,6 and 9 months] 2. Laboratory Tests (Hematology, Biochemistry and urinalysis -as mentioned in screening) [ Time Frame: at Baseline and end of study -9 months] 3. Adverse Events [ Time Frame: Each visit, Baseline through the end of study-9 months] Timepoint: 9 months | — |
Countries
India
Contacts
Public ContactDr Gayathri Sivakumar
Grace in Trinity Hospital
Outcome results
None listed