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Metformin for the Treatment of Unexplained Oligozspermia

Primary Purpose

Infertility

Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Metformin / clomid / hCG
Clomiphene citrate / hCG
Sponsored by
The Egyptian IVF-ET Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Metformin, Insulin resistance, male infertility, unexplained Oligozspermia, Clomiphene citrate, Unexplained azoospermia

Eligibility Criteria

25 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • abnormal karyotype
  • obstructive azoospermia

Sites / Locations

  • The Egyptian IVF-ET centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Metformin / clomid / hCG

Clomid / hCG

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 4, 2012
Last Updated
August 5, 2015
Sponsor
The Egyptian IVF-ET Center
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1. Study Identification

Unique Protocol Identification Number
NCT01529177
Brief Title
Metformin for the Treatment of Unexplained Oligozspermia
Official Title
Metformin for the Treatment of Unexplained Oligozspermia and Azoospermia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2012 (undefined)
Primary Completion Date
September 2016 (Anticipated)
Study Completion Date
February 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Egyptian IVF-ET Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Metformin, Insulin resistance, male infertility, unexplained Oligozspermia, Clomiphene citrate, Unexplained azoospermia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Metformin / clomid / hCG
Arm Type
Experimental
Arm Description
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.
Arm Title
Clomid / hCG
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Metformin / clomid / hCG
Other Intervention Name(s)
Glucophage / clomiphene citrate / choriomon
Intervention Description
Metformin 1000 mg daily for a week then twice daily for 2 weeks then 3 tomes daily for 6 months.
Intervention Type
Drug
Intervention Name(s)
Clomiphene citrate / hCG
Other Intervention Name(s)
Clomid / choriomon
Intervention Description
Clomiphene citrate 50 mg daily for one month, then twice daily for 2 months then 3 times per day for 3 months.
Primary Outcome Measure Information:
Title
sperm count
Description
semen analysis before the start of metformin and then every month for 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
abnormal forms of spermatozoa
Description
semen analysis before the start of metformin and then every month for 6 months
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: oligospermia ( < 10 million per mil-litter ) normal FSH high insulin Exclusion Criteria: abnormal karyotype obstructive azoospermia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ragaa mansour, MD,PhD
Organizational Affiliation
The Egyptian IVF-ET Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Egyptian IVF-ET center
City
Cairo
ZIP/Postal Code
11431
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ragaa mansour
Phone
20225254955
Email
ragaa.mansour@gmail.com
First Name & Middle Initial & Last Name & Degree
Ragaa mansour, MD,PhD

12. IPD Sharing Statement

Learn more about this trial

Metformin for the Treatment of Unexplained Oligozspermia

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