Study of Condensyl supplementary on sperm function and clinical outcome in assisted reproduction technologies resistant couples

Study of Condensyl supplementary on sperm parameters, chromatin structure, fertilization rate and embryo quality in assisted reproduction technologies resistant couples

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201510207223N6

Enrollment

100

Registered

2015-10-30

Start date

2015-11-26

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Male factor infertility. Male infertility

Interventions

Intervention 1: Intervention group: Male participants are administrated 1 or 2 Condensyl™ tablets per day for 3 to 6 months prior to current ART cycle. Sperm parameters, DNA fragmentation and deconden

Treatment - Drugs

Treatment - Other

Intervention group: Male participants are administrated 1 or 2 Condensyl™ tablets per day for 3 to 6 months prior to current ART cycle. Sperm parameters, DNA fragmentation and decondensation are compa

Control group: Failed previous ART cycles of participated infertile men.

Eligibility

Sex/Gender

All

Age

20 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Primary male factor infertility (according to the WHO-2010) and either a DFI (DNA Fragmentation Index) and SDI (Sperm Decondensation Index) higher than 10%. Exclusion criteria: Females factor infertility, female with higher than 40 years, less than 6 matured MII oocytes and thick endometrium.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Sperm concentration. Timepoint: Before and after the Condensyl™ treatment (3-6 month). Method of measurement: Optical microscope, based WHO criteria.;Sperm motility. Timepoint: Before and after the Condensyl™ treatment (3-6 month). Method of measurement: Optical microscope, based WHO criteria.;Sperm morphology. Timepoint: Before and after the Condensyl™ treatment (3-6 month). Method of measurement: Optical microscope, based WHO criteria.;Sperm decondensation. Timepoint: Before and after the Condensyl™ treatment (3-6 month). Method of measurement: Optical microscope.;DNA fragmentation. Timepoint: Before and after the Condensyl™ treatment (3-6 month). Method of measurement: Fluorescent microscope.;Fertilization rate. Timepoint: 16 - 20 h after insemination/injection. Method of measurement: View of two pronuclei with invert microscope.;Quality of embryo. Timepoint: Three days after insemination/injection. Method of measurement: Using a three-point scoring system including fragmentation rate, number of blastomere, shape and size.	—

Measure

Time frame

Sperm concentration. Timepoint: Before and after the Condensyl™ treatment (3-6 month). Method of measurement: Optical microscope, based WHO criteria.;Sperm motility. Timepoint: Before and after the Condensyl™ treatment (3-6 month). Method of measurement: Optical microscope, based WHO criteria.;Sperm morphology. Timepoint: Before and after the Condensyl™ treatment (3-6 month). Method of measurement: Optical microscope, based WHO criteria.;Sperm decondensation. Timepoint: Before and after the Condensyl™ treatment (3-6 month). Method of measurement: Optical microscope.;DNA fragmentation. Timepoint: Before and after the Condensyl™ treatment (3-6 month). Method of measurement: Fluorescent microscope.;Fertilization rate. Timepoint: 16 - 20 h after insemination/injection. Method of measurement: View of two pronuclei with invert microscope.;Quality of embryo. Timepoint: Three days after insemination/injection. Method of measurement: Using a three-point scoring system including fragmentation rate, number of blastomere, shape and size.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Hossein Nasr-Esfahani

Royan Institute (Royan Institute for Biotechnology)

mh_nasr@med.mui.ac.ir+98 31 9501 5688

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 18, 2026