Metformin for the Treatment of Unexplained Oligozspermia

NCT ID: NCT01529177

Last Updated: 2015-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2017-02-28

Brief Summary

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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.

Detailed Description

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Recently insulin resistance (IR) has been recognized as the underlying pathogenesis of chronic anovulation, hyperandrogenism, and metabolic abnormalities associated with PCOD in women. IR could be the underlying pathogenesis of chronic hypospermatogenesis leading to oligospermia and azoospermia associated with other metabolic abnormalities in men. Metformin has proven as an effective medication for not only IR but several other aspects of the PCOD including reproductive abnormalities. Therefore, insulin sensitizers, particularly metformin can be introduced as a pharmaceutical option for unexplained oligozoospermia and azoospermia associated with insulin resistance.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Metformin / clomid / hCG

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.

Group Type EXPERIMENTAL

Metformin / clomid / hCG

Intervention Type DRUG

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

Clomid / hCG

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.

Group Type EXPERIMENTAL

Clomiphene citrate / hCG

Intervention Type DRUG

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

Interventions

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Metformin / clomid / hCG

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

Intervention Type DRUG

Clomiphene citrate / hCG

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

Intervention Type DRUG

Other Intervention Names

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Glucophage / clomiphene citrate / choriomon Clomid / choriomon

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* abnormal karyotype
* obstructive azoospermia
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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The Egyptian IVF-ET Center

OTHER

Sponsor Role lead

Responsible Party

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Ragaa Mansour

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ragaa mansour, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

The Egyptian IVF-ET Center

Locations

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The Egyptian IVF-ET center

Cairo, Cairo Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Ragaa mansour

Role: primary

20225254955

Other Identifiers

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metformin for spermatogenesis

Identifier Type: -

Identifier Source: org_study_id

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