Male Infertility With Severe Oligo-terato-asteno-spermiaPhase 3PomegranateNCT01918163
Anti-oxidative Influence From Pomegranate Tablets on Male Sperm Quality in Couples Undergo Infertility Treatments Due to Male Infertility.
A Phase 3 study testing Pomegranate pills in people with Male Infertility With Severe Oligo-terato-asteno-spermia, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Some animal studies revealed that the pomegranate juice may improve sperm quality in terms of concentration, motility and morphology, as well as in fertilization rate. Minor data is available regarding the influence on male sperm. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Infertility With Severe Oligo-terato-asteno-spermia
- What is being tested?
- Pomegranate pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2013to Sep 2014
- Phase
- Phase 3
- 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 20 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- TMC of less than 5 million spermatogonia in native sperm and morphology less than 4% by Kruger criteria.
Who cannot join
- sensitivity to Pomegranate
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Reuma Barkan, 97246304223, reuma@hy.health.gov.il
About this study
Some animal studies revealed that the pomegranate juice may improve sperm quality in terms of concentration, motility and morphology, as well as in fertilization rate.
Minor data is available regarding the influence on male sperm.
Read the detailed description
Pomegranate contains a high concentration of vitamins ( C, B1, B2, B3, B5), potassium, Magnesium , Zinc and is a good source for polyphenols .Polyphenols molecules have been found to possess antioxidant properties and may effects the expression of different genes . Recent studies indicate that among foods that contain polyphenols, juice extracted from the pomegranate has the highest concentration of measurable polyphenols . Pomegranates have shown inhibitory effect on NF-κB and the MAP kinases JNK and ERK, which are critical steps in the cascade of events leading to inflammatory response. The NF- κB pathway is activated in response to bacterial infection and initiates the inflammatory cascade, which may explain the protective effect of Pomegranates on bacterial infections.
- Being tested
- Pomegranate pills
- Keywords
- pomegranate pills, male infertility, pregnancy rate, semen analysis, ROS, oxidative stress
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomegranate pillsDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| No Pills | No intervention | Patients in this group will not receive Pomegranate pills. |
| Pomegranate pills | Active comparator | The reccruited patient will receive pomegranate pills every day for 12 weeks. The control group will not be exposed for the pills. Receives: Dietary Supplement: Pomegranate pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy
Measured: 24 month
Secondary outcomes (1)
ROS (reactive oxidative stress )and Interleukins level in semen fluid
The unit for measure the ROS are Micromolar epicatechin equivalent
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male Infertility With Severe Oligo-terato-asteno-spermiaStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Einat Shalom-Paz, MD, Principal investigator, Hillel Yaffe Medical center, IVF unit, Hadera, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918163
- Sponsor's protocol ID
- 0059-13HYMC
- Acronym
- Pomegranate
- Status last verified
- Jul 2013
- First submitted
- 14 Jul 2013
- Last updated
- 7 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-oxidative Influence From Pomegranate Tablets on Male Sperm Quality in Couples Undergo Infertility Treatments Due to Male Infertility.
- ClinicalTrials.gov ID
- NCT01918163
- Acronym / sponsor ID
- Pomegranate / 0059-13HYMC
- Keywords
- pomegranate pills, male infertility, pregnancy rate, semen analysis, ROS, oxidative stress
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 7 Aug 2013 (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.
Some animal studies revealed that the pomegranate juice may improve sperm quality in terms of concentration, motility and morphology, as well as in fertilization rate.
Minor data is available regarding the influence on male sperm.
Detailed description
Pomegranate contains a high concentration of vitamins ( C, B1, B2, B3, B5), potassium, Magnesium , Zinc and is a good source for polyphenols .Polyphenols molecules have been found to possess antioxidant properties and may effects the expression of different genes . Recent studies indicate that among foods that contain polyphenols, juice extracted from the pomegranate has the highest concentration of measurable polyphenols . Pomegranates have shown inhibitory effect on NF-κB and the MAP kinases JNK and ERK, which are critical steps in the cascade of events leading to inflammatory response. The NF- κB pathway is activated in response to bacterial infection and initiates the inflammatory cascade, which may explain the protective effect of Pomegranates on bacterial infections.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Pills | No intervention | –Patients in this group will not receive Pomegranate pills. |
| Pomegranate pills | Active comparator | Dietary Supplement: Pomegranate pillsThe reccruited patient will receive pomegranate pills every day for 12 weeks. The control group will not be exposed for the pills. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- TMC of less than 5 million spermatogonia in native sperm and morphology less than 4% by Kruger criteria.
Key exclusion criteria (1 listed)
- sensitivity to Pomegranate
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 |
|---|---|---|
| Pomegranate pills | Dietary supplement | Pomegranate pills |
Primary outcome
pregnancy
Time frame: 24 month
1 secondary outcome
ROS (reactive oxidative stress )and Interleukins level in semen fluid
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
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.
Einat Shalom-Paz, MD principal investigator
Hillel Yaffe Medical center, IVF unit, Hadera, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pomegranate pills in people with Male Infertility With Severe Oligo-terato-asteno-spermia, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 1 inclusion and 1 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 2013. 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 Israel. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Einat Shalom-Paz, MD (972544899155, einatshalompaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy (time frame: 24 month). 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 2013.