Age-dependent Changes in the Responsiveness of Hypothalamic Pituitary Gonadal Axis in Men

Quaid-e-Azam University

Status and phase: Completed; Phase 3

Conditions: Sterility, Reproductive

Treatments: Biological: Human kisspeptin-10 (metastin 45-54)

Study type: Interventional

Funder types: Other

Identifiers

NCT03315325

Quaid-i-Azam University

Details and patient eligibility

About

The present study was designed to assess the responsiveness of the hypothalamic pituitary gonadal axis to kisspeptin administration with increasing age in men.

Full description

Little is known about the involvement of kisspeptin signalling in the causation of senescence-basal modulation of the GnRH-LH unit in any model and particularly in advance age men. The present study was therefore designed to assess the response of hypothalamic pituitary gonadal axis to kisspeptin administration with increasing age in healthy men. Sequential blood samples (2 ml) were obtained for 30 minutes pre and 120 minutes post-kisspeptin injection periods at 30 min intervals (-30, 0, 30, 60, 90, 120). Kisspeptin-10 was administered (1 µg/kg BW) as an intravenous bolus, immediately after collecting 0 min sample to assess the response of GnRH neurons to kisspeptin-10 with increasing age in men by determining plasma levels of LH and testosterone.

Enrollment: 15 patients

Sex: Male

Ages: 25 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age

Exclusion criteria

• Hepatic and renal complications
• Epilepsy
• Pneumonia
• Asthma
• Orchitis
• Hernia
• Cryptorchidism
• Cardiovascular diseases
• Reproductive disorders
• Mental retardation

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

Adult men

Experimental group

Description:

The average age was 25.80±0.37 years and intervention human kisspeptin-10 was administered in single iv bolus dose (1 µg/kg BW). Serial blood samples were collected for 30 min pre and 120 min post-kisspeptin injection periods at 30 min interval.

Treatment:

Biological: Human kisspeptin-10 (metastin 45-54)

Middle age men

Experimental group

Description:

The average age was 47.00±0.77 years and intervention human kisspeptin-10 was administered in single iv bolus dose (1 µg/kg BW). Serial blood samples were collected for 30 min pre and 120 min post-kisspeptin injection periods at 30 min interval.

Treatment:

Biological: Human kisspeptin-10 (metastin 45-54)

Advance age men

Experimental group

Description:

The average age was 73.20±0.91 years and intervention human kisspeptin-10 was administered in single iv bolus dose (1 µg/kg BW). Serial blood samples were collected for 30 min pre and 120 min post-kisspeptin injection periods at 30 min interval.

Treatment:

Biological: Human kisspeptin-10 (metastin 45-54)