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WithdrawnNCT02137265Updated Oct 5, 2020

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

An interventional study of Clomiphene and Placebo in Non Obstructive Azoospermia and Hypogonadism, sponsored by University of Illinois at Chicago. Withdrawn at 1 site in Spain. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-10-05.

Sponsored by University of Illinois at Chicago · Not applicable, Interventional, and Treatment

Why this study was withdrawn
No funding obtained
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years and older
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

  • Non Obstructive Azoospermia
  • Hypogonadism

Keywords

  • Azoospermia
  • Hypogonadism
  • Clomiphene
03

In context

Hypogonadism

320 studies on the registry are indexed under Hypogonadism; 39 are open to participants now.

Browse Hypogonadism studies →

Lead sponsor

University of Illinois at Chicago is the lead sponsor of 506 studies on the registry; 120 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
  • to clomiphene use: depression, heart and liver impairment, uncontrolled thyroid/adrenal dysfunction, organic intracranial lesions.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Clomiphene citrate

    Clomiphene citrate 50 mg daily during 4-6 months

    Drug: Clomiphene

  • Placebo comparator
    Placebo

    Placebo (1 pill daily) during 4-6 months

    Drug: Placebo

Interventions

  • Clomiphene citrate 50 mg orally daily

    Also known as: Clomid, Serophene

  • DrugPlacebo

    One pill every other day

    Also known as: control

06

What researchers measure

Primary outcomes

  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 outcomes

  1. Testosterone levels and Bioavailable Testosterone levels

    Time frame: After two weeks and four months with clomiphene treatment

07

Study locations

1 site
  • University of Valencia
    Valencia, Province Of Valencia 46010, Spain
08

References and documents

Publications

  • 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. PubMed 16291975 ↗
  • 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. PubMed 22958644 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2015, a primary completion of Oct 2020 and a completion of Oct 2020. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 9, 2014
First posted
May 13, 2014
Start
Sep 2015
Primary completionActual
Oct 2020
CompletionEst.
Oct 2020
Last update
Oct 5, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02137265
Responsible party
Dr. Craig Niederberger (Clarence C. Saelhof Professor and Head, Department of Urology, UIC College of Medicine, University of Illinois at Chicago) — Principal investigator
First posted
May 13, 2014
Start date
Sep 2015
Primary completion
Oct 2020
Completion
Oct 2020 (estimated)
Last update
Oct 5, 2020

Study contacts

Saturnino Luján, MD, PhD
study chair · University of Valencia

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is withdrawn, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Clomiphene

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