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

University of Illinois at Chicago

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Non Obstructive Azoospermia Hypogonadism

Interventions

ClomipheneDRUG

Clomiphene citrate 50 mg orally daily

PlaceboDRUG

One pill every other day

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Presence of sperm in the ejaculated or in the microsurgical testicular Sperm extraction (microTESE)

Time frame: After four months of clomiphene treatment

Epigenetic modifications

Time frame: After four months of clomiphene treatment

Secondary Outcomes

Testosterone levels and Bioavailable Testosterone levels

Time frame: After two weeks and four months with clomiphene treatment

Data from ClinicalTrials.gov

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