NCT01529177

Brief Summary

Insulin resistance (IR) in men may be the underlying pathogenesis for metabolic abnormalities and chronic hypospermatogenesis similar to women with polycystic ovarian disease (PCOD). Infertile men with unexplained infertility and IR may benefit from treatment with metformin.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2012

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 1, 2012

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 8, 2012

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

August 7, 2015

Status Verified

August 1, 2015

Enrollment Period

4.6 years

First QC Date

February 4, 2012

Last Update Submit

August 5, 2015

Conditions

Infertility

Keywords

MetforminInsulin resistancemale infertilityunexplained OligozspermiaClomiphene citrateUnexplained azoospermia

Outcome Measures

Primary Outcomes (1)

  • sperm count

    semen analysis before the start of metformin and then every month for 6 months

    6 months

Secondary Outcomes (1)

  • abnormal forms of spermatozoa

    6 months

Study Arms (2)

Metformin / clomid / hCG

EXPERIMENTAL

Metformin 1000 mg orally to be given daily for one week then twice daily for 2 weeks then 3 times daily for 6 months. After 3 months from starting metformin the participant will receive 2 more medications in addition to metformin: Clomid 50 mg orally per day and 5000 IU human chorionic gonadotrophin (hCG ) IM once per week for three months.

Drug: Metformin / clomid / hCG

Clomid / hCG

EXPERIMENTAL

Clomid 50 mg per day will be administered orally and human chorionic gonadotrophin ( choriomon ) 5000 IU will be administered IM once per week. Both medications will be given for 6 month.

Drug: Clomiphene citrate / hCG

Interventions

Metformin / clomid / hCGDRUG

Metformin 1000 mg daily for a week then twice daily for 2 weeks then 3 tomes daily for 6 months.

Also known as: Glucophage / clomiphene citrate / choriomon
Metformin / clomid / hCG
Clomiphene citrate / hCGDRUG

Clomiphene citrate 50 mg daily for one month, then twice daily for 2 months then 3 times per day for 3 months.

Also known as: Clomid / choriomon
Clomid / hCG

Eligibility Criteria

Age25 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • oligospermia ( \< 10 million per mil-litter )
  • normal FSH
  • high insulin

You may not qualify if:

  • abnormal karyotype
  • obstructive azoospermia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Egyptian IVF-ET center

Cairo, Cairo Governorate, 11431, Egypt

RECRUITING

MeSH Terms

Conditions

InfertilityInsulin ResistanceInfertility, Male

Interventions

MetforminClomiphene

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGenital Diseases, MaleMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Ragaa mansour, MD,PhD

    The Egyptian IVF-ET Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

February 4, 2012

First Posted

February 8, 2012

Study Start

February 1, 2012

Primary Completion

September 1, 2016

Study Completion

February 1, 2017

Last Updated

August 7, 2015

Record last verified: 2015-08

Locations

EG(1)