Letrozole therapy in men with moderate to severe oligoasthenozoospermia.

Efficacy and safety of letrozole in improving semen parameters of subfertile men with moderate to severe oligoasthenozoospermia: A placebo-controlled randomised trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/08/035725

Enrollment

Registered

2021-08-17

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

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

Conditions

Health Condition 1: N468- Other male infertility

Interventions

Intervention1: Letrozole: Letrozole is a aromatose inhibitor improves testosterone/estrogen ratio helps in improving semen parameters. tablet letrozole 2.5mg OD orally for 4 months Control Interventio

Eligibility

Inclusion criteria

Inclusion criteria: Subfertile men with moderate to severe oligoas-thenozoospermia attending male infertility clinic, WCH, JIPMER during the study period.

Exclusion criteria

Exclusion criteria: 1. Ejaculatory duct obstruction or surgery for male factor infertility 2. History of mumps orchitis, chronic tobacco and alcohol abuse. 3. Ongoing medical treatment including gonadotro-pins, anabolic steroids, and cancer chemotherapy 4. Leukocytospermia (more than 1 million/ml). 5. Severe varicocele and previously diagnosed Kli-nefelter syndrome.

Design outcomes

Primary

Measure	Time frame
To compare the efficacy of letrozole in improving semen parameters with placebo treatment in patients with moderate to severe oligoasthenozoospermia.Timepoint: After 3 months of letrozole therapy	—

Secondary

Measure	Time frame
1. To monitor the side effects of letrozole. Timepoint: monitoring will be done every month via teleconsultation(4weeks, 8weeks,12weeks) patient can immediately report if any adverse drug reactions occur. ;2. To measure the alterations in serum oestradiol and testosterone produced by letrozole. Timepoint: After 3 months of letrozole therapy	—

Countries

India

Contacts

Public ContactDr kubera NS

JIPMER

ns.drkubera@gmail.com9442550604

Outcome results

None listed

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