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Clomiphene Citrate for Second TESE in Non-obstructive Azoospermia

NCT03615547Phase 3

Key facts

Status: Withdrawn
Start: Jan 2026
Primary completion: Jan 2029
Countries: 1
Sponsor: Hospices Civils de Lyon
Modality: Small Molecules

Drugs: clomiphene
Conditions: nonobstructive azoospermia (NOA)

Overview

Phase 3, randomised, double-blind trial in nonobstructive azoospermia (NOA) comparing Clomifene citrate group with Placebo group (2 arms). Primary endpoint: Presence of sperm cells at 9 months. Planned start Jan 2026; status: withdrawn.

Design

2 arms

Study design: RandomizedDouble-blind

Clomifene citrate group
50mg of Clomifene Citrate per os daily for 9 months
Placebo group
50mg of placebo per os daily for 9 months

Who it enrols

Men aged 18-55 with BMI < 35 and confirmed Non Obstructive Azoospermia who failed a first TESE, excluding those with specific genetic abnormalities, recent malignancies, or prior hormonal treatments.

Endpoints

Primary

Presence of sperm cells9 months

Secondary

Number of sperm cells9 months
Follicle Stimulating Hormone9 months
Testosterone9 months
Luteinizing hormone9 months
Sex Hormone-Binding Globulin9 months
Bioavailable testosterone Inhibin B9 months
Number of spermatogonia9 months
Number of spermatocytes9 months

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