A clinical trial to compare the effectiveness of routine method with hyaluronic acid and hypo-osmotic swelling test on sperm selection, fertilization evaluation, embryo development, embryo quality, and implantation rate in intracytoplasmic injection of oligoasthenozoospermic men.
Objective: To compare the effectiveness of routine method with hyaluronic acid and hypo-osmotic swelling test on sperm selection, fertilization evaluation, embryo development, embryo quality, and implantation rate in intracytoplasmic injection of oligoasthenozoospermic men.
Design: A randomized double-blind clinical trial based on random number table.
Study population: Infertile men (Oligasthenos spermatozoa) will be subjected to intra-cytoplasmic sperm injection.
Inclusion criteria: Males: age range of 22-40 years; infertility duration of 2-10 years; sperm count of 5×106-20×106 ml; and sperm motility rate of 25-40%. Females: aged range of 20-37 years; lack of infertility problem; and oocytes number of 6-7.
Exclusion criteria: Males: no anomalies or spermatic leukocytes. Females: infliction with infertility problems (e.g., ovarian problems and endometriosis).
Sample size: 80 cases.
Study intervention: The control group will receive the routine sperm selection methods (i.e., sperm chromatin dispersion and microinjection), while the intervention group I will be subjected to hyaluronic acid (HA) binding and the intervention group II will undergo hypo-osmotic swelling test.
Study outcome: Evaluation and comparison of the effectiveness of fertilization evaluation, embryo development, embryo quality, and implantation rate of the two intervention groups with the control group after the intervention.
General information
Acronym
HA, Hyaluronan –binding assay
IRCT registration information
IRCT registration number:IRCT2017090336039N1
Registration date:2017-09-26, 1396/07/04
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-09-26, 1396/07/04
Registrant information
Name
Maryam Sefidgar Tehrani
Name of organization / entity
PhD Student of Anatomy
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2486
Email address
sefidgartm901@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
Expected recruitment start date
2017-10-07, 1396/07/15
Expected recruitment end date
2018-08-07, 1397/05/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A clinical trial to compare the effectiveness of routine method with hyaluronic acid and hypo-osmotic swelling test on sperm selection, fertilization evaluation, embryo development, embryo quality, and implantation rate in intracytoplasmic injection of oligoasthenozoospermic men.
Public title
Comparison of sperm selection methods in intracytoplasmic injection.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Males: age range of 22-40 years; infertility duration of 2-10 years; sperm count of 5×106-20×106 ml; and sperm motility rate of 25-40%. Females: aged range of 20-37 years; lack of infertility problem; and oocytes number of 6-7.
Exclusion criteria: Males: no anomalies or spermatic leukocytes. Females: infliction with infertility problems (e.g., ovarian problems and endometriosis).
Age
From 20 years old to 40 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Postal code
Approval date
2016-01-06, 1394/10/16
Ethics committee reference number
IR.mums.fm.REC.1394.320
Health conditions studied
1
Description of health condition studied
Oligoasthenospermia
ICD-10 code
N46
ICD-10 code description
Male infertility
Primary outcomes
1
Description
Embryo development and quality
Timepoint
3 days after intervention
Method of measurement
Grid system-Blastomere size and cytoplasm quality
2
Description
Evaluation of fertilization
Timepoint
2 weeks after intervention
Method of measurement
Microscopic observation - The number of normally fertilized oocytes
3
Description
Implantation rate
Timepoint
3 days after intervention
Method of measurement
Pregnancy pact observation by sonography and HCG test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group II: who is receiving hypo-osmotic swelling test.
Category
Treatment - Other
2
Description
Control group: who is receiving the routine sperm selection methods (i.e., sperm chromatin dispersion and microinjection).
Category
Treatment - Other
3
Description
Intervention group I: who is receiving hyaluronic acid (HA) binding.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Milad Fertility Clinic
Full name of responsible person
Maryam Sefidgar Tehrani
Street address
Montserieh Infertility Treatment Research Center, Side of Sina Hospital, East Razi Street
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Mashhad University of Medical Sciences
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
Mashhad University of Medical Sciences
Full name of responsible person
Maryam Sefidgar Tehrani
Position
PhD Student of Anatomy
Other areas of specialty/work
Street address
Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Postal code
Phone
+98 51 3800 2486
Fax
Email
sefidgartm901@mums.ac.irEbrahimzadehBA@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Ebrahimzadeh Bideskan
Position
PhD in Anatomy
Other areas of specialty/work
Street address
Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Postal code
Phone
+98 51 3800 2487
Fax
Email
EbrahimzadehBA@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Ebrahimzadeh Bideskan
Position
PhD in Histology and Embryology
Other areas of specialty/work
Street address
Opposite Mellat Park, Vakilabad Blvd
City
Mashhad
Postal code
Phone
+98 51 3800 2487
Fax
Email
EbrahimzadehBA@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)