Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02137265
Recruitment Status : Withdrawn (No funding obtained)
First Posted : May 13, 2014
Last Update Posted : October 5, 2020
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : September 2015
Actual Primary Completion Date : October 2020
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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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 identifier (NCT number): NCT02137265

Layout table for location information
University of Valencia
Valencia, Province Of Valencia, Spain, 46010
Sponsors and Collaborators
University of Illinois at Chicago
Layout table for investigator information
Study Chair: Saturnino Luján, MD, PhD University of Valencia
Publications of Results:
Layout table for additonal information
Responsible Party: Dr. Craig Niederberger, Clarence C. Saelhof Professor and Head, Department of Urology, UIC College of Medicine, University of Illinois at Chicago Identifier: NCT02137265    
Other Study ID Numbers: 2014-0343
First Posted: May 13, 2014    Key Record Dates
Last Update Posted: October 5, 2020
Last Verified: October 2020
Keywords provided by Dr. Craig Niederberger, University of Illinois at Chicago:
Additional relevant MeSH terms:
Layout table for MeSH terms
Gonadal Disorders
Endocrine System Diseases
Infertility, Male
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