Metformin for the Treatment of Unexplained Oligozspermia

Study Overview
=================
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.

Official Title
-----------------
Metformin for the Treatment of Unexplained Oligozspermia and Azoospermia

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: Metformin / clomid / hCG
* Drug: Clomiphene citrate / hCG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: oligospermia ( < 10 million per mil-litter ) normal FSH high insulin Exclusion Criteria: abnormal karyotype obstructive azoospermia

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin / clomid / hCG<br>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<br>* Metformin 1000 mg daily for a week then twice daily for 2 weeks then 3 tomes daily for 6 months.<br>* Other names: Glucophage / clomiphene citrate / choriomon;|
| Experimental: Clomid / hCG<br>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<br>* Clomiphene citrate 50 mg daily for one month, then twice daily for 2 months then 3 times per day for 3 months.<br>* Other names: Clomid / choriomon;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sperm count | semen analysis before the start of metformin and then every month for 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| abnormal forms of spermatozoa | semen analysis before the start of metformin and then every month for 6 months | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metformin, Insulin resistance, male infertility, unexplained Oligozspermia, Clomiphene citrate, Unexplained azoospermia