Protocol summary
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Study aim
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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.
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Design
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Clinical trial with control group, open labeled, phase 3 on a sample of 30 patients.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Revealing the effect of vaginal sildenafil on endometrial thickness
General information
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Reason for update
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Acronym
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IRCT registration information
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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
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Registration date
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2022-05-03, 1401/02/13
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2022-03-16, 1400/12/25
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Expected recruitment end date
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2022-08-16, 1401/05/25
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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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Public title
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Comparison of the effects of conjugated estrogen with vaginal sildenafil on endometrial diameter
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Female
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Phase
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3
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Groups that have been masked
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No information
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-03-02, 1400/12/11
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Ethics committee reference number
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IR.UMSU.REC.1400.470
Health conditions studied
1
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Description of health condition studied
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Influence of different factors on endometrial thickness
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Endometrial Thickness
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Timepoint
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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.
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Method of measurement
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Sonography
Secondary outcomes
1
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Description
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Gravidity
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Timepoint
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At the beginning of study
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Method of measurement
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Oral question
2
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Description
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Chemical pregnancy rate
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Timepoint
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After performing the intervention on the study groups
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Method of measurement
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B-HCG serum level measurement
3
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Description
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Abortion
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Timepoint
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Clinical symptoms in favor of loss of pregnancy products
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Method of measurement
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Sonography and Clinical exam based
Intervention groups
1
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Description
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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
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Category
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Treatment - Drugs
2
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Description
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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
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Oroumia University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available