NT-NOA - Novel Treatment of some men with Non-Obstructive Azoospermia Et klinisk interventionsforsøg

Conditions

Male infertility

Brief summary

Identification of sperm in either semen sample or TESE at day 90 that ideally is compared with prior TESE, if such is available from before study participation

Detailed description

Change in proliferation or apoptosis of germ cells assessed by KI-67, PCNA, cleaved parp expression or TUNEL assay on tissue from TESE at day 90 that is subsequently compared with prior TESE if such is available, Number of participants with sperm in the ejaculate (sperm concentration million/mL) assessed by semen sample delivered at day 14 or day 80, Number of pregnancies achieved by sperm from the ejaculate or from TESE, Change in serum levels of reproductive hormones (FSH, LH, AMH, Inhibin B, INSL3) at day 14 and day 80, Change in seminal fluid levels of reproductive hormones (AMH, Inhibin B, INSL3) at day 14 and day 80, Change in serum levels of sex hormones (testosterone, estradiol, SHBG) at day 14 and day 80, Change in the endocrine gonadal function (Inhibin B/FSH ratio, testosterone/LH ratio og AMH/testosterone ratio) at day 14 and day 80

Related papers

No related papers found yet.

Interventions

DRUGProlia 60 mg solution for injection in pre-filled syringe

DRUGFemar

DRUGfilmovertrukne tabletter

Eligibility

Sex/Gender

Male

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Identification of sperm in either semen sample or TESE at day 90 that ideally is compared with prior TESE, if such is available from before study participation	—

Secondary

Measure	Time frame
Change in proliferation or apoptosis of germ cells assessed by KI-67, PCNA, cleaved parp expression or TUNEL assay on tissue from TESE at day 90 that is subsequently compared with prior TESE if such is available, Number of participants with sperm in the ejaculate (sperm concentration million/mL) assessed by semen sample delivered at day 14 or day 80, Number of pregnancies achieved by sperm from the ejaculate or from TESE, Change in serum levels of reproductive hormones (FSH, LH, AMH, Inhibin B, INSL3) at day 14 and day 80, Change in seminal fluid levels of reproductive hormones (AMH, Inhibin B, INSL3) at day 14 and day 80, Change in serum levels of sex hormones (testosterone, estradiol, SHBG) at day 14 and day 80, Change in the endocrine gonadal function (Inhibin B/FSH ratio, testosterone/LH ratio og AMH/testosterone ratio) at day 14 and day 80	—

Measure

Time frame

Change in proliferation or apoptosis of germ cells assessed by KI-67, PCNA, cleaved parp expression or TUNEL assay on tissue from TESE at day 90 that is subsequently compared with prior TESE if such is available, Number of participants with sperm in the ejaculate (sperm concentration million/mL) assessed by semen sample delivered at day 14 or day 80, Number of pregnancies achieved by sperm from the ejaculate or from TESE, Change in serum levels of reproductive hormones (FSH, LH, AMH, Inhibin B, INSL3) at day 14 and day 80, Change in seminal fluid levels of reproductive hormones (AMH, Inhibin B, INSL3) at day 14 and day 80, Change in serum levels of sex hormones (testosterone, estradiol, SHBG) at day 14 and day 80, Change in the endocrine gonadal function (Inhibin B/FSH ratio, testosterone/LH ratio og AMH/testosterone ratio) at day 14 and day 80

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Countries

Denmark

Outcome results

None listed