NCT02275169

Brief Summary

Aim of the study is to evaluate the effect of highly purified human follicle-stimulating hormone treatment on the chance of retrieving testicular sperm (sperm retrieval rate) from infertile male patients with non-obstructive azoospermia of unknown origin.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2015

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 27, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

February 2, 2015

Status Verified

January 1, 2015

Enrollment Period

1 year

First QC Date

October 21, 2014

Last Update Submit

January 30, 2015

Conditions

Azoospermia

Keywords

follicle stimulating hormone treatmentazoospermia nonobstructivemale infertilityfollicle stimulating hormone

Outcome Measures

Primary Outcomes (1)

  • Sperm retrieval rate (SRR)

    testicular sperm retrieval rate after three months of urofollitropin treatment

    three months

Secondary Outcomes (2)

  • IVF pregnancy rate

    three to six months

  • IVF implantation rate

    three to six months

Study Arms (2)

Treated

EXPERIMENTAL

Urofollitropin 150 IU ampoules three times a week for three months

Drug: Urofollitropin

Controls

PLACEBO COMPARATOR

Placebo ampoules three times a week for three months

Other: Placebo

Interventions

UrofollitropinDRUG

Urofollitropin 75 IU 2 ampoules three times a week for three months

Also known as: Fostimon
Treated
PlaceboOTHER

Placebo ampoules administered three times a week for three months

Controls

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Azoospermia;
  • testis longitudinal axis less than 4.5 cm;
  • serum follicle-stimulating hormone greater than 7.6 IU/L

You may not qualify if:

  • History of testicular biopsy,
  • malignancy,
  • varicocele,
  • hyperprolactinemia,
  • thyroid disfunction,
  • chemotherapy,
  • radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Sussman EM, Chudnovsky A, Niederberger CS. Hormonal evaluation of the infertile male: has it evolved? Urol Clin North Am. 2008 May;35(2):147-55, vii. doi: 10.1016/j.ucl.2008.01.010.

    PMID: 18423236BACKGROUND

  • Schoor RA, Elhanbly S, Niederberger CS, Ross LS. The role of testicular biopsy in the modern management of male infertility. J Urol. 2002 Jan;167(1):197-200.

    PMID: 11743304BACKGROUND

  • Caroppo E, Niederberger C, Vizziello GM, D'Amato G. Recombinant human follicle-stimulating hormone as a pretreatment for idiopathic oligoasthenoteratozoospermic patients undergoing intracytoplasmic sperm injection. Fertil Steril. 2003 Dec;80(6):1398-403. doi: 10.1016/s0015-0282(03)02202-7.

    PMID: 14667875RESULT

  • Kato Y, Shiraishi K, Matsuyama H. Expression of testicular androgen receptor in non-obstructive azoospermia and its change after hormonal therapy. Andrology. 2014 Sep;2(5):734-40. doi: 10.1111/j.2047-2927.2014.00240.x. Epub 2014 Jun 12.

    PMID: 24919724RESULT

  • 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

AzoospermiaAzoospermia, NonobstructiveInfertility, Male

Interventions

Urofollitropin

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

MenotropinsGonadotropins, PituitaryGonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Ettore Caroppo, MD

    ASL Bari

    STUDY DIRECTOR

  • Craig Niederberger, MD

    University at Illinois at Chicago UIC College of Medicine

    STUDY CHAIR

  • Alayman Hussein, MD

    El Minia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ettore Caroppo, MD

CONTACT

+393479103660ecaroppo@teseo.it

Craig Niederberger, MD

CONTACT

3129969330craignied@gmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

October 21, 2014

First Posted

October 27, 2014

Study Start

February 1, 2015

Primary Completion

February 1, 2016

Study Completion

November 1, 2016

Last Updated

February 2, 2015

Record last verified: 2015-01