Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202102476293762 Date of Approval: 17/02/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Nitric Oxide Donors on Uterine and Subendometrial Blood Flow in Patients with Unexplained Infertility: A Randomized Controlled
Official scientific title Effect of Nitric Oxide Donors on Uterine and Subendometrial Blood Flow in Patients with Unexplained Infertility: A Randomized Controlled
Brief summary describing the background and objectives of the trial impaired subendometrial perfusion might reduce endometrial receptivity and possibly contribute to unexplained infertility. Nitric oxide has been demonstrated to play an essential role in reproduction and a favorable effect on subendometrial blood flow has been reported with nitric oxide donors
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied Fertility-female
Purpose of the trial Treatment: Drugs
Anticipated trial start date 20/03/2017
Actual trial start date 20/03/2017
Anticipated date of last follow up 12/03/2020
Actual Last follow-up date 12/03/2020
Anticipated target sample size (number of participants) 90
Actual target sample size (number of participants) 90
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Nitroglycerin Nitroglycerin 5mg patch per day From cycle day 2 till day of ultrasound scan Patient use a nitroderm 5mg patch for 12hours daily from cycle day 2 till day of evaluation 30
Control Group Control No tratment No treatment 30 Placebo
Control Group Fertile group No treatment No treatment 30 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
for unexplained fertility groups: age between 20–35 years, documented ovulation, patent fallopian tube either by hysterosalpingogram and/or laparoscopy, normal baseline hormonal profile and normal husband’s semen analysis according to the WHO 2010 Criteria. For fertile group: women attending at family planning clinic with at least 1 prior term pregnancy and no history of infertility or subfertility women with any identified cause for infertility women with any medical comorbidity, women receiving ovulation induction women recieiving NSAIDs women with any contraindications for nitric oxide. Adult: 19 Year-44 Year,New born: 0 Day-1 Month 20 Year(s) 35 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/10/2016 Research ethics committee
Ethics Committee Address
Street address City Postal code Country
Faculty of medicine, ain shams university, abbasia Cairo 1151 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the effect of nitroglycerine on subendometrial blood flow measured by three-dimensional power Doppler. 6 days after ovulation
Secondary Outcome the effect of nitroglycerine on uterine blood flow measured by two- dimensional color Doppler 6 days after ovulation
Secondary Outcome Endometrial thickness 6 days after ovulation
Secondary Outcome Treatment side effects 21days
Secondary Outcome Pregnancy rate 1 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ain Shams University Abbasseya square Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alaa Mostafa Abass Youssef Abasseya square Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ain Shams University Abbassseya Cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mohamed AbdelHameed AbdelHafeez Abbaseya square Cairo Egypt
Rehab Mohamed AbdelRahman Abbasseya square Cairo Egypt
Mohamed Ashraf Mohamed Farouk Kortam Abbasseya square Cairo Egypt
Alaa Mostafa Abass Youssef Abbasseya square Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alaa Mostafa Abass Youssef Angle_eye25@yahoo.com +2010 Abbasseya
City Postal code Country Position/Affiliation
Cairo Egypt Ain Shams University
Role Name Email Phone Street address
Public Enquiries Mohamed AbdelHafeez dr_m.hafeez@hotmail.com +2010 Abbasseya
City Postal code Country Position/Affiliation
Cairo Egypt Ain Shams University
Role Name Email Phone Street address
Scientific Enquiries Mohamed AbdelHafee dr_m.hafeez@hotmail.com +2010 Abbasseya
City Postal code Country Position/Affiliation
Cairo Egypt Ain Shams University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Deidentified raw data Clinical Study Report 1 year after publication Data available on request to the corresponding author by email
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information