Evaluation the efficiency of human sperm DNA fragmentation test, telomere assay and sperm selection technique on embryo development and pregnancy outcome.
Efficiency of human sperm DNA fragmentation test, telomere assay and selection technique will be evaluated on embryo development and pregnancy outcome.
Design
Blinded randomized clinical trial will be conducted on 100 infertile couples. Participants will be divided into intervention and control groups.
Settings and conduct
Infertile couples with male infertility, that the result of semen analysis will show the sperm morphology is abnormal will be entered the study. They will be divided into (Intracytoplasmic Sperm Injection) ICSI and (Intracytoplasmic Morphology Examination Sperm Injection) IMSI groups by by reputable block randomization. Sperm selection will be done under the inverted microscope by magnification of x400 in ICSI group, and more than x6600 in IMSI group. After that microinjection will be done by embryologist. (Sperm DNA Fragmentation) SDF and (Sperm Telomere Length) STL will be evaluated.
Before micro injection, sperms will be selected for IMSI and ICSI by researcher and placed in the ICSI dish, therefore embryologist will not inform from sperm selection methods.
Participants/Inclusion and exclusion criteria
This study will be carried on 100 couples with male infertility.
Inclusion criteria for male partner: Fresh ejaculated spermatozoa, concentration at least 5 million/ml, semen parameters characterized with Teratozospermia
Exclusion criteria: Testicular samples, ejaculate samples with concentration below 5 million / ml
Intervention groups
Intervention group: Intracytoplasmic Morphology Examination Sperm Injection (IMSI): Sperms will be selected by magnification more than 6000 x.
Control group or Intracytoplasmic Sperm Injection (ICSI): sperms will be selected under 400 x magnification.
Evaluation the efficiency of human sperm DNA fragmentation test, telomere assay and sperm selection technique on embryo development and pregnancy outcome.
Public title
Evaluation sperm selection technique on embryo development and pregnancy outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male participants are characterized by fresh ejaculated spermatozoa with a concentration of at least 5 million/ml , Teratozospermia and having indication for ICSI because of male infertility.
female partners aged under 38 years old, without poor ovarian response and having day 3 serum FSH < 15 IU/lit will be entered the study
Exclusion criteria:
Testicular samples and ejaculate samples with concentration below 5 million / ml
ّfemale partner with poor ovarian response, endometriosis, and cases with no embryo to transfer.
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization with quadruple blocks, the blocks are arranged as follows: Block1: ABAB, Block2: AABB، Block 3: ABBA، Block 4: BBAA, Block5: BABA، Block 6: BAAB. 25 blocks will be required to select 100 participants with male factor infertility. These blocks will be selected randomly from 1-6 by software.
For example after selection block 2: The first two participants will be dedicated to ICSI group and the second two participants will be dedicated to IMSI group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study participants and embryologists will not be informed that sperm selection will be done by ICSI or MSOME. At the first, sperm selection will be done by investigator under magnification 400 of inverted microscope for ICSI group and magnification more than 6600 for IMSI group, then sperms will be loaded in a drop of ICSI dish. Finally microinjection will be done by embryologist. Investigator is an embryologist and will not do microinjection. Investigator will explained about two techniques of sperm selections.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics research of Yazd University of Medical Sciences
Street address
Yazd Infertility Center, Bou Ali st, Timsar Fallahi st, Safaieyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
2021-12-08, 1400/09/17
Ethics committee reference number
IR.SSU.MEDICINE.REC.1400.308
Health conditions studied
1
Description of health condition studied
Male factor infertility with characterized by Teratozoospermia
ICD-10 code
N46.8
ICD-10 code description
Male Infertility
Primary outcomes
1
Description
Embryo development
Timepoint
3 days after microinjection
Method of measurement
Based on Hill's grading
2
Description
Chemical pregnancy
Timepoint
2 weeks after embryo transfer
Method of measurement
Evaluation of B HCG in blood serum
3
Description
Clinical Pregnancy
Timepoint
8 weeks after embryo transfer
Method of measurement
detection of embryo heart beat in abdominal sonography
4
Description
Fertilization Rate
Timepoint
16-18 hours after microinjection
Method of measurement
evaluation the formation of 2 pronucleous under the microscope
5
Description
Embryo implantation rate
Timepoint
6weeks after embryo transfer
Method of measurement
detection the number of gestational sac in abdominal sonography
Secondary outcomes
1
Description
Evaluation SDF and STL in sperms with scores between 0-6
Timepoint
Before randomization
Method of measurement
Sperm DNA fragmentation test, Sperm Telomere Assay
Intervention groups
1
Description
Intervention group: Intracytoplasmic Morphologic Examination Sperm Injection (IMSI). In this group, researcher will be selected sperms under inverted microscope with more than 6000x magnification.
Category
Early detection
2
Description
Control group: Intracytoplasmic Sperm Injection(ICSI). In this group, researcher will be selected sperms under inverted microscope with 400x magnification.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Infertility Center
Full name of responsible person
Dr. Azam Agharahimi
Street address
Bou Ali St, Timsar Fallahi st, Safaieyeh
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
63rahimi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Azam Agha Rahimi
Street address
Yazd Infertility Center, Bou Ali st, Timsar Fallahi st, Yazd
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 38 24785
Email
63rahimi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Fatemeh Shakeri
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Reproductive Biology
Street address
Yazd Infertility Center, Bou Ali st, Timsar Fallahi,
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
38247085
Email
Fatemehshakeri1359@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Azam Agharahimi
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Yazd Infertility Center, Bou Ali st, Timsar Fallahi st
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
38247085
Email
63rahimi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Azam Agha Rahim
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Yazd Infertility Center, Bou Ali st, Timsar Fallahi st,
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
38247085
Email
63rahimi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available