NCT02137265

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 13, 2014

Completed
1.3 years until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

October 5, 2020

Status Verified

October 1, 2020

Enrollment Period

5.1 years

First QC Date

May 9, 2014

Last Update Submit

October 1, 2020

Conditions

Non Obstructive AzoospermiaHypogonadism

Keywords

AzoospermiaHypogonadismClomiphene

Outcome Measures

Primary Outcomes (2)

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

    After four months of clomiphene treatment

  • Epigenetic modifications

    After four months of clomiphene treatment

Secondary Outcomes (1)

  • Testosterone levels and Bioavailable Testosterone levels

    After two weeks and four months with clomiphene treatment

Study Arms (2)

Clomiphene citrate

ACTIVE COMPARATOR

Clomiphene citrate 50 mg daily during 4-6 months

Drug: Clomiphene

Placebo

PLACEBO COMPARATOR

Placebo (1 pill daily) during 4-6 months

Drug: Placebo

Interventions

ClomipheneDRUG

Clomiphene citrate 50 mg orally daily

Also known as: Clomid, Serophene
Clomiphene citrate
PlaceboDRUG

One pill every other day

Also known as: control
Placebo

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Valencia

Valencia, Province of Valencia, 46010, Spain

Location

Related Publications (2)

  • 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.

    PMID: 16291975RESULT

  • 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.

    PMID: 22958644RESULT

MeSH Terms

Conditions

HypogonadismAzoospermia

Interventions

Clomiphene

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System DiseasesInfertility, MaleGenital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Saturnino Luján, MD, PhD

    University of Valencia

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clarence C. Saelhof Professor and Head, Department of Urology, UIC College of Medicine

Study Record Dates

First Submitted

May 9, 2014

First Posted

May 13, 2014

Study Start

September 1, 2015

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

October 5, 2020

Record last verified: 2020-10

Locations

ES(1)