Study of Condensyl supplementary on sperm parameters, chromatin structure, fertilization rate and embryo quality in assisted reproduction technologies resistant couples
Objectives: The aim of this study is to evaluate the effect of the Condensyl™ treatment in the ART (Assisted Reproduction Technologies)-resistant patients, in improving the sperm parameters, chromatin integrity, sperm condensation and clinical outcome with cooperation several Fertility Centers.
Design: This study include 100 infertile couples with ART -resistant that referred to the IFIC (Isfahan Fertility and Infertility Center) for ART procedure. These patients have generally at least a failure in ART cycle. All couples are informed regarding the study and consent forms are signed. This study is designed similar to a single blind clinical trial that analyzer is blinded to study.
Major Inclusion and Exclusion criteria: Inclusion criteria: Primary male factor infertility 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.
Intervention: Male participants are administrated 1 or 2 Condensyl™ tablets per day for 3 to 6 months prior to their ART cycle.
Main outcome measures (variables): Sperm parameters (according to the WHO-2010), sperm DNA fragmentation (TUNEL assay) and decondensation (aniline blue staining) are compared before and after the Condensyl™ treatment. Fertilization rate and embryo quality were compared with previous ART cycle.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201510207223N6
Registration date:2015-10-30, 1394/08/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-10-30, 1394/08/08
Registrant information
Name
Mohammad Hossein Nasr-Esfahani
Name of organization / entity
Royan Institute (Royan Institute for Biotechnology)
Country
Iran (Islamic Republic of)
Phone
+98 31 9501 5688
Email address
mh_nasr@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Royan Institute
Expected recruitment start date
2015-11-26, 1394/09/05
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of Condensyl supplementary on sperm parameters, chromatin structure, fertilization rate and embryo quality in assisted reproduction technologies resistant couples
Public title
Study of Condensyl supplementary on sperm function and clinical outcome in assisted reproduction technologies resistant couples
Purpose
Treatment
Inclusion/Exclusion 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.
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Royan Institute
Street address
Royan Institute ,Hafez St, Banihashem St, Resalat Ave, Tehran, Iran,
City
Tehran
Postal code
Approval date
2015-10-05, 1394/07/13
Ethics committee reference number
IR.ACECR.ROYAN.REC.1394.9
Health conditions studied
1
Description of health condition studied
Male factor infertility
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
Sperm concentration
Timepoint
Before and after the Condensyl™ treatment (3-6 month)
Method of measurement
Optical microscope, based WHO criteria
2
Description
Sperm motility
Timepoint
Before and after the Condensyl™ treatment (3-6 month)
Method of measurement
Optical microscope, based WHO criteria
3
Description
Sperm morphology
Timepoint
Before and after the Condensyl™ treatment (3-6 month)
Method of measurement
Optical microscope, based WHO criteria
4
Description
Sperm decondensation
Timepoint
Before and after the Condensyl™ treatment (3-6 month)
Method of measurement
Optical microscope
5
Description
DNA fragmentation
Timepoint
Before and after the Condensyl™ treatment (3-6 month)
Method of measurement
Fluorescent microscope
6
Description
Fertilization rate
Timepoint
16 - 20 h after insemination/injection
Method of measurement
View of two pronuclei with invert microscope
7
Description
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
Secondary outcomes
empty
Intervention groups
1
Description
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 compared before and after the Condensyl™ treatment.
Combination (Condensyl™) contained of opuntia fig fruits (100 mg) delivering tailored amounts of quercetin (0.05 mg) and betalain (0.001 mg) plus a mix of Group B vitamins: B2 (1.4 mg), B3 (16 mg), B6 (1.4 mg), B9 (400 μg), B12 (2.5 μg). The administered product also contained zinc (12.5 mg) and small doses of N-acetylcysteine (250 mg) and vitamin E (12 mg).
Category
Treatment - Drugs
2
Description
Control group: Failed previous ART cycles of participated infertile men.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Fertility and Infertility Center
Full name of responsible person
Mohammad Hossein Nasr-Esfahani
Street address
Fertility and Infertility Center ,Salman Farsi St, Isfahan, Iran,
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Royan Institute
Full name of responsible person
Abdolhossein Shahverdi
Street address
Royan Institute ,Hafez St, Banihashem St, Resalat Ave, Tehran, Iran,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Royan Institute
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Royan Institute (Royan Institute for Biotechnology)
Full name of responsible person
Mohammad Hossein Nasr-Esfahani
Position
Professor
Other areas of specialty/work
Street address
Royan Institute for Biotechnology ,Royan St, Salman St, Khorasgan, Isfahan, Iran,
City
Isfahan
Postal code
Phone
+98 31 9501 5688
Fax
Email
mh_nasr@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Royan Institute (Royan Institute for Biotechnology)
Full name of responsible person
Mohammad Hossein Nasr-Esfahani
Position
Professor
Other areas of specialty/work
Street address
Royan Institute for Biotechnology ,Royan St, Salman St, Khorasgan, Isfahan, Iran,
City
Isfahan
Postal code
Phone
+98 31 9501 5688
Fax
Email
mh_nasr@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Royan Institute (Royan Institute for Biotechnology
Full name of responsible person
Mohammad Hossein Nasr Esfahani
Position
Professor
Other areas of specialty/work
Street address
Royan Institute for Biotechnology ,Royan St, Salman St, Khorasgan, Isfahan, Iran,
City
Isfahan
Postal code
Phone
+98 31 9501 5688
Fax
Email
mh_nasr@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)