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Assessing the Efficacy of Clomiphene Citrate in Patients With Azoospermia and Hypoandrogenism | Clinical Trials | Clareo Health

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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

NCT02137265•University of Illinois at Chicago

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

MALE

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.

Locations (1)

University of Valencia

Valencia, Province of Valencia, Spain

Key Dates

Start Date

September 1, 2015

Primary Completion Date

October 1, 2020

Completion Date

October 1, 2020

Last Updated

October 5, 2020

Conditions

Non Obstructive AzoospermiaHypogonadism

Interventions

Clomiphene

DRUG

Placebo

DRUG

MEHMO Natural History and Biomarkers

NCT06019182

Intellectual DisabilityEpilepsy+4 more

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RECRUITINGPHASE3

52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism

NCT06689085

Hypogonadism, Male

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 5, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

MEHMO Natural History and Biomarkers

52 Week Study + 24-Month Long-Term Extension of Safety, PK, & Efficacy of XYOSTED® for Testosterone Replacement in Male Adolescents With Hypogonadism

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