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

October 1, 2020 updated by: Dr. Craig Niederberger, University of Illinois at Chicago

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Province Of Valencia
      • Valencia, Province Of Valencia, Spain, 46010
        • University of Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence of sperm in the ejaculated or in the microsurgical testicular Sperm extraction (microTESE)
Time Frame: After four months of clomiphene treatment
After four months of clomiphene treatment
Epigenetic modifications
Time Frame: After four months of clomiphene treatment
After four months of clomiphene treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Testosterone levels and Bioavailable Testosterone levels
Time Frame: After two weeks and four months with clomiphene treatment
After two weeks and four months with clomiphene treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

October 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

May 9, 2014

First Submitted That Met QC Criteria

May 12, 2014

First Posted (Estimate)

May 13, 2014

Study Record Updates

Last Update Posted (Actual)

October 5, 2020

Last Update Submitted That Met QC Criteria

October 1, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-0343

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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