InfertilityPhase 4NCT01529177
Metformin for the Treatment of Unexplained Oligozspermia
A Phase 4 study testing Metformin / clomid / hCG and Clomiphene citrate / hCG in people with Infertility, run by The Egyptian IVF-ET Center at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 years, men only
- Conditions the study is for
- Infertility
- What is being tested?
- Metformin / clomid / hCG and Clomiphene citrate / hCG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2012to Feb 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- oligospermia ( < 10 million per mil-litter )
- normal FSH
- high insulin
Who cannot join
- abnormal karyotype
- obstructive azoospermia
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
The Egyptian IVF-ET center
Cairo, Cairo Governorate, 11431
Ragaa mansour, 20225254955, ragaa.mansour@gmail.com
Ragaa mansour, MD,PhD
About this study
Official title: Metformin for the Treatment of Unexplained Oligozspermia and Azoospermia
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.
Read the 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.
- Conditions
- Infertility
- Being tested
- Metformin / clomid / hCG, Clomiphene citrate / hCG
- Keywords
- Metformin, Insulin resistance, male infertility, unexplained Oligozspermia, Clomiphene citrate, Unexplained azoospermia
- Medical subject headings
- Infertility, Insulin Resistance, Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin / clomid / hCGDrug
Also called Glucophage / clomiphene citrate / choriomon
Metformin 1000 mg daily for a week then twice daily for 2 weeks then 3 tomes daily for 6 months.
Clomiphene citrate / hCGDrug
Also called Clomid / choriomon
Clomiphene citrate 50 mg daily for one month, then twice daily for 2 months then 3 times per day for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Clomiphene citrate / hCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
sperm count
semen analysis before the start of metformin and then every month for 6 months
Measured: 6 months
Secondary outcomes (1)
abnormal forms of spermatozoa
semen analysis before the start of metformin and then every month for 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2016 (estimated)
- Study completionFeb 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Egyptian IVF-ET Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ragaa Mansour, The Egyptian IVF-ET Center
- Investigators
- Ragaa mansour, MD,PhD, Principal investigator, The Egyptian IVF-ET Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01529177
- Sponsor's protocol ID
- metformin for spermatogenesis
- Status last verified
- Aug 2015
- First submitted
- 4 Feb 2012
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metformin for the Treatment of Unexplained Oligozspermia and Azoospermia
- ClinicalTrials.gov ID
- NCT01529177
- Acronym / sponsor ID
- metformin for spermatogenesis
- Conditions
- Infertility
- Keywords
- Metformin, Insulin resistance, male infertility, unexplained Oligozspermia, Clomiphene citrate, Unexplained azoospermia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- The Egyptian IVF-ET CenterUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Feb 2017 (estimated)
- First posted
- 8 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin / clomid / hCG | Experimental | Drug: Metformin / clomid / hCGMetformin 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 / hCG | Experimental | Drug: Clomiphene citrate / hCGClomid 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. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- oligospermia ( < 10 million per mil-litter )
- normal FSH
- high insulin
Key exclusion criteria (2 listed)
- abnormal karyotype
- obstructive azoospermia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin / clomid / hCGAlso: Glucophage / clomiphene citrate / choriomonMetformin 1000 mg daily for a week then twice daily for 2 weeks then 3 tomes daily for 6 months. | Drug | Metformin / clomid / hCG |
| Clomiphene citrate / hCGAlso: Clomid / choriomonClomiphene citrate 50 mg daily for one month, then twice daily for 2 months then 3 times per day for 3 months. | Drug | Clomid / hCG |
Primary outcome
sperm count
Time frame: 6 months
semen analysis before the start of metformin and then every month for 6 months
1 secondary outcome
abnormal forms of spermatozoa
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ragaa mansour, MD,PhD principal investigator
The Egyptian IVF-ET Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin / clomid / hCG and Clomiphene citrate / hCG in people with Infertility, run by The Egyptian IVF-ET Center at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sperm count (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2015.