Evaluation of the Response to Treatment of HIV-1 Infected Men's Semen Sperm Washing Method in Pregnancy of Sero-Discordant Couples who Referred to Behavioral Diseases Consultation Center
The main goal of this before-after clinical trial, is the evaluation of response to the treatment of HIV-1 positive men's sperm washing in HIV-1 sero-discordant couples who referred to behavioral diseases consultation center of Imam Khomeini Hospital, during 4 years.
Sperm washing will do for 15 men who are living with HIV-1 and apply for having a baby, (the inclusion criteria: Being married; Men who living with HIV-1; The consent of both spouses; uninfected women and Exclusion criteria: lack of consent and Serum viral load of over 500 RNA copy number/ml). Fresh semen sample were washed and the Viral Load test is performed to assess sperm washing process, If the test's result is reported negative, the sample will send for Intra-Cytoplasmic Sperm Injection (ICSI). Washed sperm will be injected to ovum cytoplasm and embryo or embryos will be transferred to the mother's uterus. To ensure that mother has still remained uninfected, PCR HIV test is done in three periods: before the first- trimester; second-trimester and third-trimester of pregnancy.
In case of detection of HIV infection in the mother, she immediately will be connected to the counseling center and will receive antiretroviral therapy according to national guideline.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201604304076N19
Registration date:2016-06-27, 1395/04/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-27, 1395/04/07
Registrant information
Name
Minoo Mohraz
Name of organization / entity
Iranian Research Center for HIV/AIDS, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 7984
Email address
minoomohraz@ams.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Response to Treatment of HIV-1 Infected Men's Semen Sperm Washing Method in Pregnancy of Sero-Discordant Couples who Referred to Behavioral Diseases Consultation Center
Public title
Evaluation of the Response to Treatment of HIV-1 Infected Men's Semen Sperm Washing Method in Pregnancy of Sero-Discordant Couples
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being Married; Men who living with HIV-1; The consent of both spouses; Uninfected women.
Exclusion criteria:
Lack of consent; Serum Viral load of over 500 RNA copy number/ ml.
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Central building of TUMS, Ghods St, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2016-03-08, 1394/12/18
Ethics committee reference number
IR.TUMS.REC.1394.2167
Health conditions studied
1
Description of health condition studied
HIV/AIDS
ICD-10 code
B20
ICD-10 code description
Human immunodeficiency virus [HIV] disease resulting in infectious and parasitic diseases
2
Description of health condition studied
Pregnancy, childbirth and the puerperium
ICD-10 code
O82.9
ICD-10 code description
Delivery by caesarean section, unspecified
Primary outcomes
1
Description
Mother infection status
Timepoint
Before the first-trimester, second-trimester and third-trimester of pregnancy.
Method of measurement
Laboratory tests
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this method, healthy and motile uninfected sperm cells are isolated from other cells. Semen samples will be loaded on a sperm washing medium gradient and then centrifuged. Finally healthy and motile uninfected sperm cells will deposit. For the next step, sperm pellet will be load on the bottom of a sterile tube which is filled with Ham's F10 and will be incubate for 30 minutes in 37 C temperature. Healthy and motile sperm cells will swim to the upper surface of medium, and concentrate there and will be isolated for next step. For evaluating of the effectiveness of the sperm washing, viral load counting (Real Time PCR) will be done on a part of the washed sperm pellet. If the test's result is reported negative (Undetectable), the sample will send for Intra-Cytoplasmic Sperm Injection (ICSI).
Category
Prevention
2
Description
Control group: This study is a single arm clinical trial that has no control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Triangular clinic for sexual and behavioral diseases, Imam Khomeini Hospital
Full name of responsible person
Dr. Minoo Mohraz
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Resaerch Deputy of Tehran University of Medical Sciences
Full name of responsible person
Dr Younesian
Street address
Ghods Avn, Keshavarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Resaerch Deputy of Tehran 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
Iranian research Center for HIV AIDS (IRCHA)
Full name of responsible person
Dr. Minoo Mohraz
Position
Head of IRCHA
Other areas of specialty/work
Street address
Iranian Research Center for HIV/AIDS (IRCHA), Imam Khomeini Hospital
City
Tehran
Postal code
Phone
+98 21 6694 7984
Fax
Email
ircha@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iranian Research Center for HIV AIDS
Full name of responsible person
Dr. Minoo Mohraz
Position
Professor
Other areas of specialty/work
Street address
Iranian Research Center for HIV/AIDS, Imam Khomeini Hospital
City
Tehran
Postal code
Phone
+98 21 6658 1583
Fax
Email
ircha@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iranian Research Center for HIV/AIDS
Full name of responsible person
Farzaneh Vakil Ghahani
Position
Msc
Other areas of specialty/work
Street address
Iranian Research Center for HIV AIDS, Imam Khomeini Hospital, Keshavarz BLvd
City
Tehran
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)