Comparison of the effect of treatment with HCG and recombinant human FSH versus not treatment on improvement of semen parameters in infertile men after surgical repair of varicocele

Comparison of the effect of treatment with HCG and recombinant human FSH versus not treatment on improvement of semen parameters in infertile men after surgical repair of varicocele: a randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201203039014N3

Enrollment

Registered

2012-04-25

Start date

2012-05-21

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male infertility due to varicocele. Male infertility

Interventions

Intervention 1: The intervention group will be undergone varicocelectomy and then will receive 75 IU recombinant human FSH subcutaneously three times a week and 5000 IU HCG intramuscularly once a week

Treatment - Drugs

The intervention group will be undergone varicocelectomy and then will receive 75 IU recombinant human FSH subcutaneously three times a week and 5000 IU HCG intramuscularly once a week for three month

The control group will be undergone varicocelectomy only without hormone therapy.

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: Inclusion criteria are: (a) having unilateral or bilateral palpable varicocele; (b) history of infertility for at least one-year; (c) having healthy wife; having abnormal spermogram. Exclusion criteria are: (a) having no testis in scrotum; (b) having acute urogenital infection; (c) medical history of abnormal function of testis such as: trauma, torsion, cryptorchidism, vas deferens obstruction, abnormal karyotype, diabetes, chemotherapy, any history of surgical treatment on testis, scrotum or pituitary gland; (d) contraindication of FSH such as high level of FSH in serum or uncontrolled dysfunction of thyroid or adrenal glands; (e) BMI>40; (f) substance abuse such as alcohol, narcotics, or anabolic asteroids; (g) testis smaller than 4 mL in ultrasonography; (h) azoospermia (no spermatozoid); (i) using gonadotropin.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
The outcome of interest is improvement of the semen parameters including concentration (106/mm2), motility (%), and morphology (%) of spermatozoid. Timepoint: Three months. Method of measurement: Laboratory tests.	—

Secondary

Measure	Time frame
The secondary outcome of interest is the increase in the rate of pregnancy and decrease in the duration of waiting time for pregnancy. Timepoint: One year. Method of measurement: History taking.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Jalal Poorolajal

Research Center for Health Sciences, Department of Epidemiology & Biostatistics

poorolajal@umsha.ac.ir+98 81 1838 0090

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026