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Investigating sperm parameters, DNA integrity, embryo cytokinetic and pregnancy rate from sperms selected by cumulus column compared to the control group in male factor infertile couples.

Protocol summary

Study aim
Investigating sperm parameters, DNA integrity, embryo cytokinetic and pregnancy rate obtained from sperms selected by cumulus column compared to the control group in infertile couples with male factor
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 100 patients. Statistical software will be used for randomization.
Settings and conduct
The study will be conducted at the Research Institute of Reproductive Sciences in Yazd. In this study, the patient, embryologist and gynecologist will be considered blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: infertile couples with male cause candidates for ICSI, reproductively healthy women with at least 6 Mɪɪ eggs and age less than 38 years Exclusion criteria: infertile patients with severe male factor, frozen sperm samples, tissue samples, female age over 38 years.
Intervention groups
In the control group of sperm samples after preparation by density gradient method, sperm selection is done only by density gradient and in the study group, sperm selection in addition to density gradient will be done by passing through the cumulus column, and then for ICSI are used.
Main outcome variables
Application of non-invasive techniques to improve the results of ART treatment cycles for male factor infertile patients

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180130038561N2
Registration date: 2023-09-03, 1402/06/12
Registration timing: prospective

Last update: 2023-09-03, 1402/06/12
Update count: 0
Registration date
2023-09-03, 1402/06/12
Registrant information
Name
Esmat Mangoli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 7085
Email address
es.mangoli@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating sperm parameters, DNA integrity, embryo cytokinetic and pregnancy rate from sperms selected by cumulus column compared to the control group in male factor infertile couples.
Public title
Sperm selection by cumulus column
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertility couples with a male factor without varicocele diagnosis (at least one of the three sperm parameters outside the normal values ​​defined by WHO) and a normal woman based on regular cycles, normal hysterosalpingogram, normal vaginal ultrasound, age under 38 years Estradiol level below 3000 and the presence of at least 3 follicles with a size > 14 on the trigger day Referring to the first or second cycle(s) of ICSI Having at least 6 mature MII oocytes for ICSI Male age less than 45 years
Exclusion criteria:
Male patients with severe male factor according to WHO criteria Frozen sperm sample Sperm sample obtained by aspiration or extraction from the testis HIV positive patients PCOS and endometriosis patients Patients at risk of OHSS
Age
To 38 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization method is done individually and by statistical software
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patient, the clinical embryologist, and the gynecologist are considered blind
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
Bouali Ave.Timsar Fallahi ST.Yazd
City
Yazd
Province
Yazd
Postal code
8916877391
Approval date
2023-06-27, 1402/04/06
Ethics committee reference number
IR.SSU.MEDICINE.REC.1402.118

Health conditions studied

1

Description of health condition studied
Male infertility
ICD-10 code
N46
ICD-10 code description
Azoospermia NOS Oligospermia NOS

Primary outcomes

1

Description
chemical pregnancy
Timepoint
2 weeks after embryo transfer
Method of measurement
Beta hCG test

Secondary outcomes

1

Description
Differences in oocyte quality between individuals
Timepoint
The quality of oocyte is checked after puncture and before in vitro fertilization
Method of measurement
Grading based on standard criteria

Intervention groups

1

Description
Intervention group: The sperm selected for injection have passed through the cumulus column
Category
Treatment - Other

2

Description
Control group: The sperm selected for injection prepared with the density gradient method
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Yazd Reproductive Science Institute, Research & clinical center for infertility, Shahid Sadoughi Uni
Full name of responsible person
Prof. Abbas Aflatoonian
Street address
Bouali Ave. Timsar Fallahi ST. Yazd
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
abbas_aflatoonian@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Nasim Tabibnezhad
Street address
Bouali Ave. Timsar Fallahi ST. Yazd
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7086
Email
nasimtabibnejad@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
Public
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
Dr. Esmat Mangoli
Position
Assisted Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Bouali Ave. Timsar Fallahi St. Yazd
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
es.mangoli@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr. Esmat Mangoli
Position
Assisted Professor
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Bouali Ave.Timsar Fallahi St.Yazd
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Email
es.mangoli@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Esmat Mangoli
Position
PhD students
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
Bouali Ave, Safayieh,
City
Yazd
Province
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
es.mangoli@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Maintaining and respecting the confidentiality of patient information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The results of the study will be published in the form of an article and the data file will be provided to the journal
When the data will become available and for how long
One year after the results are published
To whom data/document is available
researchers
Under which criteria data/document could be used
To write review studies and meta-analysis
From where data/document is obtainable
Principal Researcher
What processes are involved for a request to access data/document
Contact by email to the corresponding author and ensure the person's good faith
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