Comparison of the effects of conjugated estrogen with vaginal sildenafil on endometrial diameter of patients treated by intracytoplasmic sperm injection(ICSI) admitting to Urmia Shahid Motahari and Mahzad Hospital
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Ethics committees
#1
2022-03-14, 1400/12/23
2022-03-02, 1400/12/11
2022-03-1402 00:00:00
Recruitment centers
#1
Name of recruitment center - English: Urmia SHAHID MOTAHARI hospital
Name of recruitment center - Persian: بیمارستان شهید مطهری ارومیه
Full name of responsible person - English: Farnaz Ettehadi
Full name of responsible person - Persian: فرناز اتحادی
Street address - English: AYATOLLAH KASHANI street, Urmia
Street address - Persian: ارومیه خیابان آیت الله کاشانی
City - English: Urmia
City - Persian: ارومیه
Province: West Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 57146154637
Phone: +98 44 3223 7080
Fax:
Email: farnazettehadi1989@yahoo.com
Web page address:
Name of recruitment center - English: Urmia Shahid Motahari hospital
Name of recruitment center - Persian: بیمارستان شهید مطهری ارومیه
Full name of responsible person - English: Farnaz Ettehadi
Full name of responsible person - Persian: فرناز اتحادی
Street address - English: Ayatollah Kashani street, Urmia
Street address - Persian: ارومیه خیابان آیت الله کاشانی
City - English: Urmia
City - Persian: ارومیه
Province: West Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 57146154637
Phone: +98 44 3223 7080
Fax:
Email: farnazettehadi1989@yahoo.com
Web page address:
Name of recruitment center - English: Urmia SHAHID MOTAHARIShahid Motahari hospital Name of recruitment center - Persian: بیمارستان شهید مطهری ارومیه Full name of responsible person - English: Farnaz Ettehadi Full name of responsible person - Persian: فرناز اتحادی Street address - English: AYATOLLAH KASHANIAyatollah Kashani street, Urmia Street address - Persian: ارومیه خیابان آیت الله کاشانی City - English: Urmia City - Persian: ارومیه Province: West Azarbaijan Country: Iran (Islamic Republic of) Postal code: 57146154637 Phone: +98 44 3223 7080 Fax: Email: farnazettehadi1989@yahoo.com Web page address:
#2
Name of recruitment center - English: Urmia MAHZAD hospital
Name of recruitment center - Persian: بیمارستان مهزاد ارومیه
Full name of responsible person - English: Farnaz Ettehadi
Full name of responsible person - Persian: فرناز اتحادی
Street address - English: HASANI sreet, Urmia
Street address - Persian: ارومیه خیابان حسنی
City - English: Urmia
City - Persian: ارومیه
Province: West Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5714783734
Phone: +98 44 3223 4897
Fax:
Email: farnazettehadi1989@yahoo.com
Web page address:
Name of recruitment center - English: Urmia Mahzad hospital
Name of recruitment center - Persian: بیمارستان مهزاد ارومیه
Full name of responsible person - English: Farnaz Ettehadi
Full name of responsible person - Persian: فرناز اتحادی
Street address - English: Hasani sreet, Urmia
Street address - Persian: ارومیه خیابان حسنی
City - English: Urmia
City - Persian: ارومیه
Province: West Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5714783734
Phone: +98 44 3223 4897
Fax:
Email: farnazettehadi1989@yahoo.com
Web page address:
Name of recruitment center - English: Urmia MAHZADMahzad hospital Name of recruitment center - Persian: بیمارستان مهزاد ارومیه Full name of responsible person - English: Farnaz Ettehadi Full name of responsible person - Persian: فرناز اتحادی Street address - English: HASANIHasani sreet, Urmia Street address - Persian: ارومیه خیابان حسنی City - English: Urmia City - Persian: ارومیه Province: West Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5714783734 Phone: +98 44 3223 4897 Fax: Email: farnazettehadi1989@yahoo.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: صابر قلیزاده
Full name of responsible person - Persian: Saber Gholizadeh
Street address - English: Emergency alley, RESALAT Blvd, Urmia
Street address - Persian: ارومیه، بلوار رسالت، کوی اورژانس
City - English: Urmia
City - Persian: ارومیه
Province: West Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5714783734
Phone: +98 44 3223 4897
Fax:
Email: academic.relations@umsu.ac.ir
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Saber Gholizadeh
Full name of responsible person - Persian: صابر قلیزاده
Street address - English: Emergency alley, Resalat Blvd, Urmia
Street address - Persian: ارومیه، بلوار رسالت، کوی اورژانس
City - English: Urmia
City - Persian: ارومیه
Province: West Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: 5714783734
Phone: +98 44 3223 4897
Fax:
Email: academic.relations@umsu.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: صابر قلیزادهSaber Gholizadeh Full name of responsible person - Persian: Saber Gholizadehصابر قلیزاده Street address - English: Emergency alley, RESALATResalat Blvd, Urmia Street address - Persian: ارومیه، بلوار رسالت، کوی اورژانس City - English: Urmia City - Persian: ارومیه Province: West Azarbaijan Country: Iran (Islamic Republic of) Postal code: 5714783734 Phone: +98 44 3223 4897 Fax: Email: academic.relations@umsu.ac.ir Web page address:
Protocol summary
Study aim
Comparison of uterine endometrial thickness between conjugated estrogen and sildenafil groups in patients with low endometrial thickness referred to Shahid Motahari and Mahzad hospitals in Urmia.
Design
Clinical trial with control group, open labeled, phase 3 on a sample of 30 patients.
Settings and conduct
Patients with endometrial preparation routine protocol of endometrial thickness less than 7 mm will be included in the study and will be divided into two groups. The intervention group will receive 2 mg of estradiol valerate 2 tablets as TDS plus vaginal sildenafil 50 mg as TDS and the control group will receive 2 mg of estradiol valerate 2 tablets as TDS plus conjugated estrogen 1.25 mg as BID. The study site will be MOTAHARI and MAHZAD hospitals in Urmia.
Participants/Inclusion and exclusion criteria
Inclusion criteria included patients undergoing IVF who did not conceive according to the standard uterine preparation protocol and having two frozen embryo or more. Exclusion criteria also include nitrate treated hypertension (HTN), cerebrovascular accident (CVA), thrombophilia, and use of nitrate-derived drugs.
Intervention groups
control: Continuation of 2 mg estradiol valerate(two tablets) TDS plus conjugated estrogen 1.25 mg BID from day 2 to day of embryo transfer.
case: Continuation of 2 mg estradiol valerate (two tablets) TDS plus sildenafil 50 mg TDS from the day of endometrial thickness above 7 mm The start has begun to determine the BHCG response.
Main outcome variables
Revealing the effect of vaginal sildenafil on endometrial thickness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220314054278N1
Registration date:2022-05-03, 1401/02/13
Registration timing:registered_while_recruiting
Last update:2025-10-17, 1404/07/25
Update count:1
Registration date
2022-05-03, 1401/02/13
Registrant information
Name
farnaz ettehadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3331 5198
Email address
farnazettehadi1989@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-16, 1400/12/25
Expected recruitment end date
2022-08-16, 1401/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of conjugated estrogen with vaginal sildenafil on endometrial diameter of patients treated by intracytoplasmic sperm injection(ICSI) admitting to Urmia Shahid Motahari and Mahzad Hospital
Public title
Comparison of the effects of conjugated estrogen with vaginal sildenafil on endometrial diameter
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1.Patients undergoing IVF who did not conceive according to the standard uterine preparation protocol
2.Having two frozen embryos or more
Exclusion criteria:
Hypertension(HTN) treated with nitrates
Cerebrovascular accident(CVA)
Thrombophilia
Using drugs with nitrate derivatives
Age
No age limit
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
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
Ethics committee of Urmia university of medical sciences
Street address
End of emergency alley, Resalat Blvd, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2022-03-02, 1400/12/11
Ethics committee reference number
IR.UMSU.REC.1400.470
Health conditions studied
1
Description of health condition studied
Influence of different factors on endometrial thickness
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Endometrial Thickness
Timepoint
Day 14 of the menstrual cycle at the time of routine endometrial preparation protocol and after receiving vaginal sildenafil as TDS with 2 mg estradiol valerate as TDS.
Method of measurement
Sonography
Secondary outcomes
1
Description
Gravidity
Timepoint
At the beginning of study
Method of measurement
Oral question
2
Description
Chemical pregnancy rate
Timepoint
After performing the intervention on the study groups
Method of measurement
B-HCG serum level measurement
3
Description
Abortion
Timepoint
Clinical symptoms in favor of loss of pregnancy products
Method of measurement
Sonography and Clinical exam based
Intervention groups
1
Description
Intervention group: Patients receiving Estradiol Valerate 2 mg(Brand name: Abu Reihan estradiol valerate, Abu Reihan pharmaceuticals) 2 tablets TDS plus vaginal sildenafil 50 mg(Brand name: Viagra, Pfizer company) TDS
Category
Treatment - Drugs
2
Description
Control group: Patients receiving estradiol valerate 2 mg(Brand name: Abu Reihan estradiol valerate, Abu Reihan pharmaceuticals) 2 tablets TDS plus conjugated estrogen 1.25 mg(Brand name: Estromarin, Abu Reihan pharmaceuticals) BID from day 2 of cycle to day of embryo transfer
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia Shahid Motahari hospital
Full name of responsible person
Farnaz Ettehadi
Street address
Ayatollah Kashani street, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
57146154637
Phone
+98 44 3223 7080
Email
farnazettehadi1989@yahoo.com
2
Recruitment center
Name of recruitment center
Urmia Mahzad hospital
Full name of responsible person
Farnaz Ettehadi
Street address
Hasani sreet, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
farnazettehadi1989@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Saber Gholizadeh
Street address
Emergency alley, Resalat Blvd, Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
academic.relations@umsu.ac.ir
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
Farnaz Ettehdi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No17, Sogol alley, North Shahriar Ave, Valiasr, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5715859497
Phone
+98 41 3331 5198
Email
farnazettehadi1989@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Farnaz Ettehadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No 17, Sogol alley, North Shahriar Ave, Valiasr, Tabriz
City
urmia
Province
West Azarbaijan
Postal code
5715859497
Phone
+98 41 3331 5198
Email
farnazettehadi1989@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Farnaz Ettehadi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No17, Sogol alley, North Shahriar Ave, Valiasr, Tabriz
City
Urmia
Province
West Azarbaijan
Postal code
5715859497
Phone
+98 41 3331 5198
Email
farnazettehadi1989@yahoo.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