Comparison of the effect of Follicle Stimulating Hormone(FSH) and Follicle Stimulating Hormone(FSH) along with growth hormone(GH) on ovulation stimulation in Intrauterine insemination (IUI) candidate patients and pregnancy outcomes
Comparison of the effect of FSH administration with FSH administration along with growth hormone in stimulation of ovulation in IUI candidate patients and pregnancy results
Design
After entering the study, patients will be divided into two groups: A (FSH) and group B (FSH plus growth hormone). Group A patients will receive FSH with a dose of 75 units on day 6 and 8 of cycle and group B, FSH in addition to 75 units of FSH on day 6 and 8 of cycle 3 units of growth hormone as a subcutaneous injection daily from day 2 of cycle to trigger day. For the trigger day, 5 thousand units of HCG ampoules are injected intramuscularly to both groups. And then 36 hours after the trigger day, IUI will be done and the results of IUI will be checked in both groups.
Settings and conduct
Infertility Clinic of Kawsar Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Age between 25 and 35 years
2- Patients with at least one healthy fallopian tube
3- Normal spermogram
4- Regular menstrual cycle (26 to 30 days)
5- FSH level below 20 mIU/ml
Intervention groups
Group A patients will receive FSH with a dose of 75 units on day 6 and 8 of cycle and group B, FSH in addition to 75 units of FSH on day 6 and 8 of cycle 3 units of growth hormone as a subcutaneous injection daily from day 2 of cycle to trigger day.
Main outcome variables
Chemical pregnancy rate ,Clinical pregnancy rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230512058157N1
Registration date:2023-06-21, 1402/03/31
Registration timing:prospective
Last update:2023-06-21, 1402/03/31
Update count:0
Registration date
2023-06-21, 1402/03/31
Registrant information
Name
Sonia Sadeghpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 5079
Email address
sadeghpour.s@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2024-10-21, 1403/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Follicle Stimulating Hormone(FSH) and Follicle Stimulating Hormone(FSH) along with growth hormone(GH) on ovulation stimulation in Intrauterine insemination (IUI) candidate patients and pregnancy outcomes
Public title
Comparison of the effect of FSH and FSH along with growth hormone on ovulation stimulation in IUI candidate patients and pregnancy outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 25 and 35 years
Patients with at least one healthy fallopian tube
Normal spermogram
Regular menstrual cycle (26 to 30 days)
FSH level below 20 mIU/ml
Exclusion criteria:
Age
From 25 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will be divided randomly into two groups (A and B).The data collection form will be provided to the analyzer with the header A and B without mentioning the type of method performed on the patient. The results of the data analysis, will be provided to the analyst without mentioning the name of the method (group A and B) to examine the consequences.So, these people will be blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
Kausar Women's Comprehensive Hospital
City
urmia
Province
West Azarbaijan
Postal code
5715859497
Approval date
2022-08-13, 1401/05/22
Ethics committee reference number
IR.UMSU.REC.1401.168
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Antral follicle counts
Timepoint
before after treatment
Method of measurement
Sonography
2
Description
serum level of FSH
Timepoint
before after treatment
Method of measurement
ELISA
3
Description
Serum levels of insulin-like growth factor I (IGF-I)
Timepoint
before after treatment
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Follicle stimulating hormone along with growth hormone
Category
Treatment - Drugs
2
Description
Control group: FSH
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Dr.sonia sadeghpour
Street address
Hasani Blvd
City
urmia
Province
West Azarbaijan
Postal code
5715859497
Phone
+98 21 3346 5079
Email
dr.sadehpour.s@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Saber Golizadeh
Street address
Jahad St., Resalat Blvd., Urmai University of Medical Sciences, Urmia, Iran
City
urmia
Province
West Azarbaijan
Postal code
5715833631
Phone
+98 44 3346 5079
Email
dr.sadeghpour.s@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Dr.Sonia Sadeghpour
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hassani Ave,Kowsar hospital
City
Urmia
Province
West Azarbaijan
Postal code
5715859497
Phone
+98 44 3346 5079
Email
dr.sadeghpour.s@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Sonia Sadeghpoor
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hasani Street
City
Urmia
Province
West Azarbaijan
Postal code
5715859497
Phone
+98 44 3346 6169
Email
sadeghpour.s@umsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Sonia Sadeghpoor
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Hasani Street
City
Urmia
Province
West Azarbaijan
Postal code
5715859497
Phone
+98 44 3346 6169
Email
sadeghpour.s@umsu.ac.ir
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
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
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