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Trial record 13 of 19 for:    "Hypogonadism" | "Calcium, Dietary"

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

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ClinicalTrials.gov Identifier: NCT02137265
Recruitment Status : Recruiting
First Posted : May 13, 2014
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Craig Niederberger, University of Illinois at Chicago

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
Non Obstructive Azoospermia Hypogonadism Drug: Clomiphene Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 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 : September 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


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 Name: control




Primary Outcome Measures :
  1. Presence of sperm in the ejaculated or in the microsurgical testicular Sperm extraction (microTESE) [ Time Frame: After four months of clomiphene treatment ]
  2. Epigenetic modifications [ Time Frame: After four months of clomiphene treatment ]

Secondary Outcome Measures :
  1. Testosterone levels and Bioavailable Testosterone levels [ Time Frame: After two weeks and four months with clomiphene treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02137265


Contacts
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Contact: Saturnino Luján, MD, PhD 3129969330 satlujan@gmail.com
Contact: Craig Niederberger, MD, FRCS 3129969330 craignied@gmail.com

Locations
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Spain
University of Valencia Recruiting
Valencia, Province of Valencia, Spain, 46010
Contact: Satur Luján, MD, PhD    +34 616 936 453 ext 440692    satlujan@gmail.com   
Contact: Craig S Niederberger, MD, FACS    3129969330    craign@uic.edu   
Principal Investigator: Satur Luján, MD, PhD         
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
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Study Chair: Saturnino Luján, MD, PhD University of Valencia

Publications of Results:
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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     History of Changes
Other Study ID Numbers: 2014-0343
First Posted: May 13, 2014    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Keywords provided by Dr. Craig Niederberger, University of Illinois at Chicago:
Azoospermia
Hypogonadism
Clomiphene
Additional relevant MeSH terms:
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Hypogonadism
Calcium Chelating Agents
Azoospermia
Gonadal Disorders
Endocrine System Diseases
Infertility, Male
Infertility
Genital Diseases, Male
Citric Acid
Sodium Citrate
Clomiphene
Enclomiphene
Zuclomiphene
Anticoagulants
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators