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

Information source: University of Illinois at Chicago
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non Obstructive Azoospermia; Hypogonadism

Intervention: Clomiphene (Drug); Placebo (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: University of Illinois at Chicago

Official(s) and/or principal investigator(s):
Craig Niederberger, MD, FRCS, Study Chair, Affiliation: Department of Urology, UIC College of Medicine

Overall contact:
Saturnino Luján, MD, PhD, Phone: 3129969330, Email: satlujan@gmail.com

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

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

Secondary outcome: Testosterone levels and Bioavailable Testosterone levels

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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 and Contacts

Saturnino Luján, MD, PhD, Phone: 3129969330, Email: satlujan@gmail.com

University of Illinois, Chicago, Illinois 60612, United States; Not yet recruiting
Craig Niederberger, MD, FRCS, Phone: 312-996-9330, Email: craignied@gmail.com
Satur Luján, MD, PhD, Phone: 3129969330, Email: satlujan@gmail.com
Satur Luján, MD, PhD, Sub-Investigator
Additional Information

Starting date: September 2015
Last updated: February 25, 2015

Page last updated: August 23, 2015

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