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

Primary Purpose

Non Obstructive Azoospermia, Hypogonadism

Status
Withdrawn
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Clomiphene
Placebo
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Obstructive Azoospermia focused on measuring Azoospermia, Hypogonadism, Clomiphene

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Clomiphene citrate

Placebo

Arm Description

Clomiphene citrate 50 mg daily during 4-6 months

Placebo (1 pill daily) during 4-6 months

Outcomes

Primary Outcome Measures

Presence of sperm in the ejaculated or in the microsurgical testicular Sperm extraction (microTESE)
Epigenetic modifications

Secondary Outcome Measures

Testosterone levels and Bioavailable Testosterone levels

Full Information

First Posted
May 9, 2014
Last Updated
October 1, 2020
Sponsor
University of Illinois at Chicago
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1. Study Identification

Unique Protocol Identification Number
NCT02137265
Brief Title
Assessing the Efficacy of Clomiphene Citrate in Patients With Azoospermia and Hypoandrogenism
Official Title
A Randomized, Double-blind, Placebo-controlled Trial of Clomiphene Citrate of Clomiphene Citrate in Hypoandrogenism and Azoospermia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Why Stopped
No funding obtained
Study Start Date
September 2015 (undefined)
Primary Completion Date
October 2020 (Actual)
Study Completion Date
October 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Obstructive Azoospermia, Hypogonadism
Keywords
Azoospermia, Hypogonadism, Clomiphene

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clomiphene citrate
Arm Type
Active Comparator
Arm Description
Clomiphene citrate 50 mg daily during 4-6 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (1 pill daily) during 4-6 months
Intervention Type
Drug
Intervention Name(s)
Clomiphene
Other Intervention Name(s)
Clomid, Serophene
Intervention Description
Clomiphene citrate 50 mg orally daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
control
Intervention Description
One pill every other day
Primary Outcome Measure Information:
Title
Presence of sperm in the ejaculated or in the microsurgical testicular Sperm extraction (microTESE)
Time Frame
After four months of clomiphene treatment
Title
Epigenetic modifications
Time Frame
After four months of clomiphene treatment
Secondary Outcome Measure Information:
Title
Testosterone levels and Bioavailable Testosterone levels
Time Frame
After two weeks and four months with clomiphene treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saturnino Luján, MD, PhD
Organizational Affiliation
University of Valencia
Official's Role
Study Chair
Facility Information:
Facility Name
University of Valencia
City
Valencia
State/Province
Province Of Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
16291975
Citation
Hussein A, Ozgok Y, Ross L, Niederberger C. Clomiphene administration for cases of nonobstructive azoospermia: a multicenter study. J Androl. 2005 Nov-Dec;26(6):787-91; discussion 792-3. doi: 10.2164/jandrol.04180.
Results Reference
result
PubMed Identifier
22958644
Citation
Hussein A, Ozgok Y, Ross L, Rao P, Niederberger C. Optimization of spermatogenesis-regulating hormones in patients with non-obstructive azoospermia and its impact on sperm retrieval: a multicentre study. BJU Int. 2013 Mar;111(3 Pt B):E110-4. doi: 10.1111/j.1464-410X.2012.11485.x. Epub 2012 Sep 7.
Results Reference
result

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

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