Metformin for the Treatment of Unexplained Oligozspermia
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|ClinicalTrials.gov Identifier: NCT01529177|
Recruitment Status : Unknown
Verified August 2015 by Ragaa Mansour, The Egyptian IVF-ET Center.
Recruitment status was: Recruiting
First Posted : February 8, 2012
Last Update Posted : August 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Drug: Metformin / clomid / hCG Drug: Clomiphene citrate / hCG||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||600 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Metformin for the Treatment of Unexplained Oligozspermia and Azoospermia|
|Study Start Date :||February 2012|
|Estimated Primary Completion Date :||September 2016|
|Estimated Study Completion Date :||February 2017|
Experimental: 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.
Drug: Metformin / clomid / hCG
Metformin 1000 mg daily for a week then twice daily for 2 weeks then 3 tomes daily for 6 months.
Other Name: Glucophage / clomiphene citrate / choriomon
Experimental: 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.
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.
Other Name: Clomid / choriomon
- sperm count [ Time Frame: 6 months ]semen analysis before the start of metformin and then every month for 6 months
- abnormal forms of spermatozoa [ Time Frame: 6 months ]semen analysis before the start of metformin and then every month for 6 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01529177
|The Egyptian IVF-ET center||Recruiting|
|Cairo, Egypt, 11431|
|Contact: Ragaa mansour 20225254955 firstname.lastname@example.org|
|Principal Investigator: Ragaa mansour, MD,PhD|
|Principal Investigator:||Ragaa mansour, MD,PhD||The Egyptian IVF-ET Center|