Infertility, MaleNCT04509583
The Role of Micro Nutrient Supplement in Improvement of the Sperm DNA Fragmentation
A study testing PROFortil and Vitamin E in people with Infertility, Male, run by Hue University of Medicine and Pharmacy at 1 site in Vietnam.
Trial summary
Male from infertile couples are tested for semen analysis and sperm DNA fragmentation. Any case with high DNA fragmentation index (DFI) will be randomized indicated for multi-micro nutrient supplement (PROfortil™) in 3 months and then checked again post-treatment for (DFI). Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Infertility, Male
- What is being tested?
- PROFortil and Vitamin E
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteVietnam
- Study dates
- 18 Nov 2019to 30 Dec 2021
- 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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male from infertile couples
Who cannot join
- Men with acute systemic diseases
- acute urinary tract infection
- hepatic function disorders
- malignant diseases
- retrograde ejaculation
- azoospermia
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Hue University of Medicine and Pharmacy, Hue University
Huế, Thua Thien, 530000
About this study
Official title: Is Micro Nutrient Supplement Effective in Improving the Sperm DNA Fragmentation
Male from infertile couples are tested for semen analysis and sperm DNA fragmentation. Any case with high DNA fragmentation index (DFI) will be randomized indicated for multi-micro nutrient supplement (PROfortil™) in 3 months and then checked again post-treatment for (DFI). The IVF/ICSI cycles will be analyzed for pregnancy outcomes
Read the detailed description
Higher DFI is correlated with poor embryo development, lower implantation rate in intracytoplasmic sperm injection (ICSI) cycles and higher miscarriage rate.
The effectiveness of micro nutrients (PROfortil™) has been proven in improving sperm quality including sperm cell density, progressive motility and normal morphology.
This randomized controlled trial includes male from infertile couples treated at the Center for Reproductive Endocrinology and Infertility, Hue University hospital, Vietnam from November 2019 to November 2020.
The semen samples were collected from the husband after 3-5 days of abstinence and then evaluated for sperm motility, vitality, concentration and morphology by the guideline of World Health Organization (WHO) 2010.
Sperm DNA fragmentation (SDF) was measured using a sperm chromatin dispersion (SCD) test (Halosperm® kit, Halotech, Madrid, Spain). A total of 500 sperms were examined by only one highly trained technician to decrease variability. DFI was expressed as the percentage of sperms with small halo, without halo and degraded sperms over total of 500 sperms.
Any case with high DNA fragmentation index (DFI >=30%) will be randomized indicated for (group 1) micro nutrient supplement (PROfortil™, twice daily) plus Vitamin E (Enat 400, once per day) in 3 months and (group 2) only Vitamin E (Enat 400 once per day) then checked again post-treatment for (DFI).
The IVF/ICSI cycles will then be analyzed for embryo quality, pregnancy outcomes including biochemical pregnancy rate, clinical pregnancy rate, on-going pregnancy, miscarriage.
- Conditions
- Infertility, Male
- Being tested
- PROFortil, Vitamin E
- Keywords
- Sperm DNA fragmentation, micronutrient, In vitro fertilization
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROFortilDietary supplement
Multi-micronutrient supplement (PROfortil™, twice daily) plus Vitamin E (Enat 400, once per day) in 3 months
Vitamin EOther
Only Vitamin E (Enat 400, once per day) in 3 months
| Study group | Role | What they receive |
|---|---|---|
| PROFortil group | Experimental | Men with increased sperm DNA fragmentation (>=30%) will be indicated for multi-micronutrient supplement (PROfortil™, twice daily) plus Vitamin E (Enat 400, once per day) in 3 months then checked again post-treatment for DF).
The IVF/ICSI cycles will then be analyzed for embryo quality, pregnancy outcomes including biochemical pregnancy rate, clinical pregnancy rate, on-going pregnancy, miscarriage. Receives: Dietary Supplement: PROFortil |
| Vitamin E group | Other | Any case with high DNA fragmentation index (DFI >=30%) will be randomized indicated only Vitamin E (Enat 400 once per day) in 3 months then checked again post-treatment for (DFI).
The IVF/ICSI cycles will then be analyzed for embryo quality, pregnancy outcomes including biochemical pregnancy rate, clinical pregnancy rate, on-going pregnancy, miscarriage. Receives: Other: Vitamin E |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of DFI after micro nutrients supplements
The change of sperm DNA Fragmentation Index after treatment with PROfortil in 3 months
Measured: 3 months
Secondary outcomes (2)
The impact of micro nutrients supplements on embryo quality after ICSI
The blastocyst quality in IVF/ICSI cycles after treatment with PROFortil
Measured: 3 months
The impact of micro nutrients supplements on pregnancy outcomes after ICSI
The pregnancy rate in IVF/ICSI cycles after treatment with PROFortil
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start18 Nov 2019
- Primary completion1 Mar 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infertility, MaleStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Men from infertile couples with increased sperm DNA fragmentation will be randomized devided into 2 groups: (1) with multi-micronutrient supplements (PROFortilTM) plus Vitamin E and (2) with Vitamin E only.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hue University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Minh Tam Le, M.D.,Ph.D, Study director, Hue University of Medicine and Pharmacy, Hue University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509583
- Sponsor's protocol ID
- H2019/433
- Status last verified
- Feb 2023
- First submitted
- 5 May 2020
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nguyen ND, Le MT, Tran NQT, Nguyen QHV, Cao TN. Micronutrient supplements as antioxidants in improving sperm quality and reducing DNA fragmentation. Basic Clin Androl. 2023 Sep 14;33(1):23. doi: 10.1186/s12610-023-00197-9.
PubMed 37704942
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Micro Nutrient Supplement Effective in Improving the Sperm DNA Fragmentation
- ClinicalTrials.gov ID
- NCT04509583
- Acronym / sponsor ID
- H2019/433
- Conditions
- Infertility, Male
- Keywords
- Sperm DNA fragmentation, micronutrient, In vitro fertilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Hue University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 18 Nov 2019 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 12 Aug 2020 (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.
Male from infertile couples are tested for semen analysis and sperm DNA fragmentation. Any case with high DNA fragmentation index (DFI) will be randomized indicated for multi-micro nutrient supplement (PROfortil™) in 3 months and then checked again post-treatment for (DFI). The IVF/ICSI cycles will be analyzed for pregnancy outcomes
Detailed description
Higher DFI is correlated with poor embryo development, lower implantation rate in intracytoplasmic sperm injection (ICSI) cycles and higher miscarriage rate.
The effectiveness of micro nutrients (PROfortil™) has been proven in improving sperm quality including sperm cell density, progressive motility and normal morphology.
This randomized controlled trial includes male from infertile couples treated at the Center for Reproductive Endocrinology and Infertility, Hue University hospital, Vietnam from November 2019 to November 2020.
The semen samples were collected from the husband after 3-5 days of abstinence and then evaluated for sperm motility, vitality, concentration and morphology by the guideline of World Health Organization (WHO) 2010.
Sperm DNA fragmentation (SDF) was measured using a sperm chromatin dispersion (SCD) test (Halosperm® kit, Halotech, Madrid, Spain). A total of 500 sperms were examined by only one highly trained technician to decrease variability. DFI was expressed as the percentage of sperms with small halo, without halo and degraded sperms over total of 500 sperms.
Any case with high DNA fragmentation index (DFI >=30%) will be randomized indicated for (group 1) micro nutrient supplement (PROfortil™, twice daily) plus Vitamin E (Enat 400, once per day) in 3 months and (group 2) only Vitamin E (Enat 400 once per day) then checked again post-treatment for (DFI).
The IVF/ICSI cycles will then be analyzed for embryo quality, pregnancy outcomes including biochemical pregnancy rate, clinical pregnancy rate, on-going pregnancy, miscarriage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Men from infertile couples with increased sperm DNA fragmentation will be randomized devided into 2 groups: (1) with multi-micronutrient supplements (PROFortilTM) plus Vitamin E and (2) with Vitamin E only.
| Arm | Type | Receives |
|---|---|---|
| PROFortil group | Experimental | Dietary Supplement: PROFortilMen with increased sperm DNA fragmentation (>=30%) will be indicated for multi-micronutrient supplement (PROfortil™, twice daily) plus Vitamin E (Enat 400, once per day) in 3 months then checked again post-treatment for DF). The IVF/ICSI cycles will then be analyzed for embryo quality, pregnancy outcomes including biochemical pregnancy rate, clinical pregnancy rate, on-going pregnancy, miscarriage. |
| Vitamin E group | Other | Other: Vitamin EAny case with high DNA fragmentation index (DFI >=30%) will be randomized indicated only Vitamin E (Enat 400 once per day) in 3 months then checked again post-treatment for (DFI). The IVF/ICSI cycles will then be analyzed for embryo quality, pregnancy outcomes including biochemical pregnancy rate, clinical pregnancy rate, on-going pregnancy, miscarriage. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male from infertile couples
Key exclusion criteria (6 listed)
- Men with acute systemic diseases
- acute urinary tract infection
- hepatic function disorders
- malignant diseases
- retrograde ejaculation
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 |
|---|---|---|
| PROFortilMulti-micronutrient supplement (PROfortil™, twice daily) plus Vitamin E (Enat 400, once per day) in 3 months | Dietary supplement | PROFortil group |
| Vitamin EOnly Vitamin E (Enat 400, once per day) in 3 months | Other | Vitamin E group |
Primary outcome
The change of DFI after micro nutrients supplements
Time frame: 3 months
The change of sperm DNA Fragmentation Index after treatment with PROfortil in 3 months
2 secondary outcomes
The impact of micro nutrients supplements on embryo quality after ICSI
Time frame: 3 months
The impact of micro nutrients supplements on pregnancy outcomes after ICSI
Time frame: 3 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 22 Jun 2023.
- Derived from this study: PubMed 37704942Nguyen ND, Le MT, Tran NQT, Nguyen QHV, Cao TN. Micronutrient supplements as antioxidants in improving sperm quality and reducing DNA fragmentation. Basic Clin Androl. 2023 Sep 14;33(1):23. doi: 10.1186/s12610-023-00197-9.
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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.
Minh Tam Le, M.D.,Ph.D study director
Hue University of Medicine and Pharmacy, Hue University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PROFortil and Vitamin E in people with Infertility, Male, run by Hue University of Medicine and Pharmacy at 1 site in Vietnam.
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 6 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 22 Jun 2023. 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 Vietnam. 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.
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?
The change of DFI after micro nutrients supplements (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04509583, which also lists 1 linked publication.
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 22 Jun 2023.