NCT05483621

Brief Summary

Urologists and reproductive specialists are often challenged when facing patients with severe male infertility scenarios. In particular, the treatment of men with NOA demands a deeper insight. In such cases, .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2022

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

12 months

First QC Date

July 31, 2022

Last Update Submit

October 17, 2023

Conditions

Azoospermia, Nonobstructive

Outcome Measures

Primary Outcomes (1)

  • Hormonal treatment

    About 100 participants receiving Beta HCG (5000 IU I.M) twice weekly to evaluate the effect of hormonal stimulation for patients with non-obstructive azoospermia

    from baseline up to 3 months after the treatment day.

Study Arms (2)

Hormonal therapy Group

EXPERIMENTAL

Administration of hormonal therapy (as Beta HCG (5000 IU I.M) twice weekly for three months

Drug: Beta-hCG

L-carnitine Group (Control)

OTHER

Administration of L-carnitine 1000 mg twice daily for three months

Drug: Beta-hCG

Interventions

Beta-hCGDRUG

Treatment of spermatogenesis

Hormonal therapy GroupL-carnitine Group (Control)

Eligibility Criteria

Age19 Years - 72 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men with primary infertility due to non-obstructive azoospermia in two seminal analysis

You may not qualify if:

  • Patients with non-obstructive azoospermia with normal or low level of FSH.
  • Patients with serum testosterone lower than 3 nmol/L.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology department - faculty of medicine, South Valley university

Qina, Egypt

Location

MeSH Terms

Conditions

Azoospermia, Nonobstructive

Interventions

Chorionic Gonadotropin, beta Subunit, Human

Intervention Hierarchy (Ancestors)

Chorionic GonadotropinGonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPlacental HormonesPeptidesAmino Acids, Peptides, and ProteinsPregnancy ProteinsProteinsBiomarkers, TumorBiomarkersBiological Factors

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: to evaluate the effect of hormonal stimulation for patients with non-obstructive azoospermia
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2022

First Posted

August 2, 2022

Study Start

March 1, 2021

Primary Completion

February 15, 2022

Study Completion

March 1, 2022

Last Updated

October 19, 2023

Record last verified: 2023-10

Locations

EG(1)