Comparison of the pregnancy rate between two methods of tubal sperm perfusion with standard intrauterine sperm insemination in infertile patients referred to the infertility clinic
Determining and comparing the pregnancy rate between two methods of tubal sperm perfusion with standard intrauterine sperm insemination in infertile patients referred to the infertility clinic of Ali Ibn Abi Talib (AS) Zahedan Hospital in 2018
Design
Based on the day of the person's visit to the center, those who visit on an even day will enter the FSP group and those who visit on an odd day will enter the IUI group. The IUI group will be named A and the FSP group will be named B
Settings and conduct
The IUI group will be named A and the FSP group will be named B, and the outcome assessor and statistician will be blinded to the grouping. Then IUI and FSP treatment cycles will be implemented for patients of each group by the treatment team of the infertility center.
Participants/Inclusion and exclusion criteria
The inclusion criteria includes all women who refer to fertility centers of Ali Ibn Abi Talib Zahedan Hospital. Inclusion criteria include female age of 20 to 40 years, infertility of at least 10 years and body mass index (BMI) of less than 27 Kg/m2, hormone tests and hysterosalpingography (at least one normal fallopian tube). (moderate to severe oligospermia), bilateral obstruction in hysterosalpingography, very weak ovarian function, very weak ovarian reserve, the presence of simultaneous uterine anomalies and the presence of fallopian tube obstruction.
Intervention groups
FSP group: suspension inoculation of sperm with a volume of 4 cc into the uterus or fallopian tube
IUI group: Sperm injection into the uterus
Main outcome variables
β-Hcg test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221203056697N1
Registration date:2023-01-02, 1401/10/12
Registration timing:retrospective
Last update:2023-01-02, 1401/10/12
Update count:0
Registration date
2023-01-02, 1401/10/12
Registrant information
Name
Farahnaz Farzaneh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6650 9283
Email address
farahnaz1826@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-21, 1398/06/30
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
2019-09-21, 1398/06/30
Actual recruitment end date
2022-09-21, 1401/06/30
Trial completion date
empty
Scientific title
Comparison of the pregnancy rate between two methods of tubal sperm perfusion with standard intrauterine sperm insemination in infertile patients referred to the infertility clinic
Public title
Comparison of pregnancy rate between two methods of tubal sperm perfusion with standard intrauterine sperm insemination
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
The age of the woman is 20 to 40 years
Infertility less than 10 years
Body mass index (BMI) less than 27 Kg/m2
Hysterosalpingography (at least one normal tube)
Exclusion criteria:
Male infertility (moderate to severe oligospermia)
Bilateral obstruction in hysterosalpingography
Ovaries with very poor function
Very poor ovarian reserve
The presence of uterine anomalies at the same time and the presence of obstruction of the uterine tubes
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The outcome assessor and data analyst were blinded to patient characteristics and patient grouping
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Persian Gulf Highway - University of Medical Sciences Campus Complex
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743175
Approval date
2020-02-16, 1398/11/27
Ethics committee reference number
IR.ZAUMS.REC.1399.048
Health conditions studied
1
Description of health condition studied
positive pregnancy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
positive pregnancy
Timepoint
Two weeks after treatment
Method of measurement
β-Hcg test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: On days 3-7 of the monthly cycle after the ultrasound, 2 tablets of letrozole 2.5 mg (Iran hormone. Company) are prescribed daily for 5 nights. Then HMG gonadotropin or Gonal-f (Karma Company) was prescribed from day 7 to 10 cycles based on the patient's need in the amount of 3 to 4 pills daily. Next, 5 to 7 days after the last dose of letrozole, ultrasound is performed. When the follicles reach the size of 18 to 24 mm, HCG (Karma Company) is injected intramuscularly, and 36 to 48 hours later, the semen sample prepared by the gradient process with a volume of 4-6 cc is injected into the uterus through the IUI catheter.IUI group, which is intrauterine insemination of sperm
Category
Treatment - Other
2
Description
Intervention group: FSP group,which is Fallopian tube sperm perfusion
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali ibn Abitaleb Hospital
Full name of responsible person
Farahnaz Farzaneh
Street address
Persian Gulf Highway - University of Medical Sciences Campus Complex
City
zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
farahnaz1826@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
noor mohammad Bakhshani-Vice President of Research and Technology
Street address
Persian Gulf Highway - University of Medical Sciences Campus Complex
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
farahnaz1826@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Farahnaz Farzaneh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Persian Gulf Highway - University of Medical Sciences Campus Complex
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
farahnaz1826@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Farahnaz Farzaneh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hemmat steet
City
Tehran
Province
Tehran
Postal code
9816743463
Phone
+98 21 6650 9283
Fax
Email
farahnaz1826@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Farahnaz Farzaneh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hemmat steet
City
Tehran
Province
Tehran
Postal code
9816743463
Phone
+98 21 6650 9283
Fax
Email
farahnaz1826@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Comparison of pregnancy rate between IUI and Fallopian tube Sperm Perfusion methods in patients with infertility referring to Ali ibn Abitaleb Hospital in Zahedan in 2019
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Request from the responsible author of the article
From where data/document is obtainable
farahnaz1826@yahoo.com
What processes are involved for a request to access data/document