The Role of Micro Nutrient Supplement in Improvement of the Sperm DNA Fragmentation

Hue University of Medicine and Pharmacy

Status: Completed

Conditions: Infertility, Male

Treatments: Dietary Supplement: PROFortil; Other: Vitamin E

Study type: Interventional

Funder types: Other

Identifiers

NCT04509583

H2019/433

Details and patient eligibility

About

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

Full 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.

Enrollment: 71 patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male from infertile couples

Exclusion criteria

• Men with acute systemic diseases
• acute urinary tract infection
• hepatic function disorders
• malignant diseases
• retrograde ejaculation
• azoospermia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

71 participants in 2 patient groups

PROFortil group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: PROFortil

Vitamin E group

Other group

Description:

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.

Treatment:

Other: Vitamin E