Assessing the Efficacy of Clomiphene Citrate in Patients With Azoospermia and Hypoandrogenism

A Randomized, Double-blind, Placebo-controlled Trial of Clomiphene Citrate of Clomiphene Citrate in Hypoandrogenism and Azoospermia

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02137265

Enrollment

Registered

2014-05-13

Start date

2015-09-30

Completion date

2020-10-31

Last updated

2020-10-05

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

Conditions

Hypogonadism, Non Obstructive Azoospermia

Keywords

Azoospermia, Hypogonadism, Clomiphene

Brief summary

Hypothesis: Prescribed clomiphene citrate to azoospermic patients with hypoandrogenism could improve the sperm retrieval in either fresh sperm or after surgical sperm extraction.

Detailed description

Hypogonadism (low testosterone level) is frequently observed in men presenting with non obstructive azoospermia. Controversy exists regarding the efficacy of preoperative hormonal manipulation in patients with hypogonadism. However, it is possible that hormonal therapy increases intra-testicular testosterone levels, and with a rise in serum testosterone, sperm production and surgical success with microTESE improve.

Interventions

DRUGClomiphene

Clomiphene citrate 50 mg orally daily

DRUGPlacebo

One pill every other day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients over 18 years old. * Man seeking fertility treatment. * Azoospermia confirmed in at least 2 semen analyses with centrifugation. * Testosterone \<300 ng/dL and Bioavailable Testosterone\<156 ng/dL.

Exclusion criteria

* Presence of genetic disorders: Y chromosome deletions or abnormal karyotypes. * Luteinizing hormone (LH) \>25 IU/mL. * Estradiol \> 40 ng/dL. * Hypogonadotropic hypogonadism (LH \<2 IU/mL and Follicle Stimulating Hormone (FSH) \<1 IU/mL). * Obstructive azoospermia (FSH \<7.6 IU/mL plus testicle longitudinally axis \>4.6 cm or bilateral absence of vas deferens or surgical history of vasectomy). * Clinical varicocele (palpable or visible in physical exam) * Previous history of cryptorchidism. * Use of chemotherapy, testosterone, or anti-androgen in the last two years. Partner \>40 years or female factor infertility associated. * Contraindications to clomiphene use: depression, heart and liver impairment, uncontrolled thyroid/adrenal dysfunction, organic intracranial lesions.

Design outcomes

Primary

Measure	Time frame
Presence of sperm in the ejaculated or in the microsurgical testicular Sperm extraction (microTESE)	After four months of clomiphene treatment
Epigenetic modifications	After four months of clomiphene treatment

Secondary

Measure	Time frame
Testosterone levels and Bioavailable Testosterone levels	After two weeks and four months with clomiphene treatment

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026