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
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