Male InfertilityNCT04177667
Body Mass Index and Age Correlate With Antioxidant Supplementation Effects on Sperm Quality
A study testing Proxeed in people with Male Infertility, run by University of Roma La Sapienza.
Trial summary
Spermatozoa are vulnerable to lack of energy and oxidative stress as a result of elevated levels of reactive oxygen species. Therefore, it is essential that appropriate nutrients are available during maturation. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Male Infertility
- What is being tested?
- Proxeed
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2014to 30 Nov 2017
- Phase
- Interventional
- 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 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- men with oligo- and/or astheno- and/or terato-zoospermia
- with or without varicocele
- men aged between 18 and 50 years
- men from couples with history of difficulty conceiving for more than 12 months
Who cannot join
- subjects with known hypersensitivity to any of the treatment compound
- history of undescended testes or cancer
- endocrine disorders
- history of post-pubertal mumps
- genitourinary surgery
- obstructive azoospermia or obstructive pathology of the urogenital system
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- autoimmune disease
- cystic fibrosis
- history of taking any therapy affecting fertility within last 3 months
- excessive consumption of alcohol or regular use of illicit or "recreational" drugs
- positive serology for HIV
- subjects following any special diet
- any condition which in the opinion of the investigator might put the subject at risk by participation in this study and subjects involved in any other clinical trials
About this study
Official title: Body Mass Index and Age Correlate With Antioxidant Supplementation Effects on Sperm Quality: Post-hoc Analyses From a Double-blind Placebo-controlled Trial
Spermatozoa are vulnerable to lack of energy and oxidative stress as a result of elevated levels of reactive oxygen species. Therefore, it is essential that appropriate nutrients are available during maturation.
This randomized, double-blind, placebo-controlled trial investigated the effect of 6 months supplementation with carnitines and other micronutrients on sperm quality in 104 subjects with oligo- and/or astheno- and/or teratozoospermia with or without varicocele. Semen analyses were done at the beginning and end of the treatment. In addition to main analyses, post-hoc analyses for age and body mass index (BMI) were carried out. Results were interpreted by dividing the population into two age and BMI classes.
- Conditions
- Male Infertility
- Being tested
- Proxeed, Placebo
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProxeedDietary supplement
Treatment with dietary supplement for male infertility for Proxeed Arm
PlaceboOther
Treatment with placebo for Placebo Arm
| Study group | Role | What they receive |
|---|---|---|
| Proxeed arm | Active comparator | Subjects received 2 packets per day for 6 months of supplement (1000 mg of L-carnitine, 725 mg of fumarate, 500 mg of acetyl-L-carnitine, 1000 mg of fructose, 50 mg of citric acid, 50 µg of selenium, 20 mg of coenzyme Q10, 90 mg of vitamin C, 10 mg of zinc, 200 µg of folic acid and 1.5 µg of vitamin B12) Receives: Dietary Supplement: Proxeed |
| Placebo arm | Placebo comparator | Subjects received 2 packets per day for 6 months of placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of sperm concentration (millions/ml) on spermogram of infertile men
Efficacy of the therapy on sperm concentration (millions/ml) of subject affected by male infertility with or without varicocele. Parameters have been compared in accordance with body mass index and age.
Measured: 6 months
Evaluation of sperm motility (%) on spermogram of infertile men
Efficacy of the therapy on sperm motility (%) of subject affected by male infertility with or without varicocele. Parameters have been compared in accordance with body mass index and age.
Measured: 6 months
Evaluation of sperm normal morphology (%) on spermogram of infertile men
Efficacy of the therapy on sperm normal morphology (%) of subject affected by male infertility with or without varicocele. Parameters have been compared in accordance with body mass index and age.
Measured: 6 months
Secondary outcomes (1)
Evaluation of pregnancy rate (number)
Pregnancy rate is the number of pregnancies including live births, still births and therapeutic abortions
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 posted26 Nov 2019
- Study start1 Dec 2014
- Primary completion30 Jun 2015
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ettore De Berardinis, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177667
- Sponsor's protocol ID
- PXP-001A
- Status last verified
- Nov 2019
- First submitted
- 19 Nov 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Mass Index and Age Correlate With Antioxidant Supplementation Effects on Sperm Quality: Post-hoc Analyses From a Double-blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04177667
- Acronym / sponsor ID
- PXP-001A
- Conditions
- Male Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 26 Nov 2019 (actual)
- 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.
Spermatozoa are vulnerable to lack of energy and oxidative stress as a result of elevated levels of reactive oxygen species. Therefore, it is essential that appropriate nutrients are available during maturation.
This randomized, double-blind, placebo-controlled trial investigated the effect of 6 months supplementation with carnitines and other micronutrients on sperm quality in 104 subjects with oligo- and/or astheno- and/or teratozoospermia with or without varicocele. Semen analyses were done at the beginning and end of the treatment. In addition to main analyses, post-hoc analyses for age and body mass index (BMI) were carried out. Results were interpreted by dividing the population into two age and BMI classes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proxeed arm | Active comparator | Dietary Supplement: ProxeedSubjects received 2 packets per day for 6 months of supplement (1000 mg of L-carnitine, 725 mg of fumarate, 500 mg of acetyl-L-carnitine, 1000 mg of fructose, 50 mg of citric acid, 50 µg of selenium, 20 mg of coenzyme Q10, 90 mg of vitamin C, 10 mg of zinc, 200 µg of folic acid and 1.5 µg of vitamin B12) |
| Placebo arm | Placebo comparator | Other: PlaceboSubjects received 2 packets per day for 6 months of placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- men with oligo- and/or astheno- and/or terato-zoospermia
- with or without varicocele
- men aged between 18 and 50 years
- men from couples with history of difficulty conceiving for more than 12 months
Key exclusion criteria (13 listed)
- subjects with known hypersensitivity to any of the treatment compound
- history of undescended testes or cancer
- endocrine disorders
- history of post-pubertal mumps
- genitourinary surgery
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 |
|---|---|---|
| ProxeedTreatment with dietary supplement for male infertility for Proxeed Arm | Dietary supplement | Proxeed arm |
| PlaceboTreatment with placebo for Placebo Arm | Other | Placebo arm |
Primary outcome
Evaluation of sperm concentration (millions/ml) on spermogram of infertile men
Time frame: 6 months
Efficacy of the therapy on sperm concentration (millions/ml) of subject affected by male infertility with or without varicocele. Parameters have been compared in accordance with body mass index and age.
Evaluation of sperm motility (%) on spermogram of infertile men
Time frame: 6 months
Efficacy of the therapy on sperm motility (%) of subject affected by male infertility with or without varicocele. Parameters have been compared in accordance with body mass index and age.
Evaluation of sperm normal morphology (%) on spermogram of infertile men
Time frame: 6 months
Efficacy of the therapy on sperm normal morphology (%) of subject affected by male infertility with or without varicocele. Parameters have been compared in accordance with body mass index and age.
1 secondary outcome
Evaluation of pregnancy rate (number)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Proxeed in people with Male Infertility, run by University of Roma La Sapienza.
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 4 inclusion and 13 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: finished, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of sperm concentration (millions/ml) on spermogram of infertile men (time frame: 6 months). The study lists 3 primary outcomes in all. 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 26 Nov 2019.