Clincosm LogoSign in Get a demo

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

Sponsor
University of Illinois at Chicago (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02137265
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
61
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-blind, Placebo-controlled Trial of Clomiphene Citrate of Clomiphene Citrate in Hypoandrogenism and Azoospermia
Study Start Date :
Sep 1, 2015
Actual Primary Completion Date :
Oct 1, 2020
Anticipated Study Completion Date :
Oct 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Clomiphene citrate

Clomiphene citrate 50 mg daily during 4-6 months

Drug: Clomiphene
Clomiphene citrate 50 mg orally daily
Other Names:
  • Clomid
  • Serophene

    		•
    Placebo Comparator: Placebo

    Placebo (1 pill daily) during 4-6 months

    Drug: Placebo
    One pill every other day
    Other Names:
  • control

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Presence of sperm in the ejaculated or in the microsurgical testicular Sperm extraction (microTESE) [After four months of clomiphene treatment]

    2. Epigenetic modifications [After four months of clomiphene treatment]

    Secondary Outcome Measures

    1. Testosterone levels and Bioavailable Testosterone levels [After two weeks and four months with clomiphene treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Valencia Valencia Province Of Valencia Spain 46010

    Sponsors and Collaborators

    • University of Illinois at Chicago

    Investigators

    • Study Chair: Saturnino Luján, MD, PhD, University of Valencia

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Craig Niederberger, Clarence C. Saelhof Professor and Head, Department of Urology, UIC College of Medicine, University of Illinois at Chicago
    ClinicalTrials.gov Identifier:
    NCT02137265
    Other Study ID Numbers:
    • 2014-0343
    First Posted:
    May 13, 2014
    Last Update Posted:
    Oct 5, 2020
    Last Verified:
    Oct 1, 2020
    Keywords provided by Dr. Craig Niederberger, Clarence C. Saelhof Professor and Head, Department of Urology, UIC College of Medicine, University of Illinois at Chicago
    Azoospermia
    Hypogonadism
    Clomiphene
    Additional relevant MeSH terms:
    Azoospermia
    Hypogonadism
    Clomiphene

    Study Results

    No Results Posted as of Oct 5, 2020