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.: PACTR201907658492123 Date of Approval: 24/07/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The effect of Sildenafil on the success rate of ovulation induction with Clomiphene citrate versusClomiphene Citrate alone in unexplained infertility patients
Official scientific title Sildenafil together with clomiphene citrate to improve success rate of ovulation induction in unexplained infertility patients
Brief summary describing the background and objectives of the trial unexplained infertility accounts for 25% of infertile couples. The increased cost of assisted reproduction technology (ART) makes clomiphene citrate the first choice in such patients. However; it is associated with adverse effects on the endometrium making the need for additional drugs to overcome this obstacle is a must. Sildenafil citrate leads to smooth muscle relaxation and vasodilatation. This may enhance endometrial development together with increased endometrial receptivity. Objectives: Assess the role of sildenafil citrate in ovulation induction for improvement of ovulation success rate in unexplained infertility women undergoing induction of ovulation with Clomiphene citrate (CC).
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: Other
Anticipated trial start date 01/06/2018
Actual trial start date 01/01/2018
Anticipated date of last follow up 31/12/2018
Actual Last follow-up date 31/12/2018
Anticipated target sample size (number of participants) 80
Actual target sample size (number of participants) 80
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group placebo CC 100 mg once daily from day 3 to day 7 of the last menstrual cycle. placebo will be added twice daily from day 8-12 of the same cycle single cycle recruitment with data collection over 4 months Group A (control group): will be given CC 100 mg (Clomid, Glopal Napi) tablet orally once daily from 3rd- 7th day of the cycle and placebo orally twice per day from 8th-12th day of the same cycle. Folliculometery will be done by trans-vaginal ultrasound:  It will be done on day 3 of the cycle, to assess a baseline size, number of follicles and to detect endometrial thickness, as well as exclude if any cyst remains from previous hyper-stimulation or otherwise.  It will be repeated on day 9, 11 and 13 till follicular scan reaches 18 – 25mm. When the follicles reach ≥18 ml, injection of 5000 IU of HCG IM to trigger ovulation to both groups will be given. Pregnancy will be assessed two weeks after ovulation by Beta HCG test in blood. 40 Placebo
Experimental Group clomiphene citrate and sildenafil CC 100 mg once daily from day 3 to day 7 of the last menstrual cycle will be given. oral sildenafil citrate 25 mg will be added twice daily from day 8-12 of the same cycle. single cycle recruitment, 5 days experimental group: will be given CC 100 mg (Clomid, Glopal Napi) tablet orally once daily from 3rd - 7th day of the cycle and sildenafil citrate 25mg (Respatio, Pharma Right) tablet orally twice per day from 8th-12th day of the same cycle. Folliculometery will be assessed by trans-vaginal ultrasound:  It will be done first on day 3 of the cycle, to assess a baseline size, number of follicles and to detect endometrial thickness, as well as exclude if any cyst remains from previous hyper-stimulation or otherwise.  It will be repeated on day 9, 11 and 13 till follicular scan reaches 18 – 25mm. When the follicles reach ≥18 ml, injection of 5000 IU of HCG IM to trigger ovulation.Pregnancy will be assessed two weeks after ovulation by Beta HCG test in blood. 40
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
infertile women whether it was primary or secondary, women's age: (18-40 years old), menstrual cycle from (24-35 days) normal recent semen analysis of the husband within last 6 months. presence of ovarian cysts, abnormal hormonal profile, significant cardiovascular disease, serious liver disease or renal failure history of pelvic pathology "pelvic adhesions". Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 Year(s) 40 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 19/12/2017 research ethics committee faculty of medicine suez canal university
Ethics Committee Address
Street address City Postal code Country
ring roud, kilo 4.5 ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To assess the success of sildenafil plus clomiphene citrate versus clomiphene citrate alone for induction of ovulation in unexplained infertility patients. at the end of the cycle
Secondary Outcome To assess the effects of sildenafil on pregnancy rate, endometrial thickness, follicular development, and side effects after ovulation induction cycles with clomiphene citrate. at the end of the cycle
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine suez canal university ring road, kilo 4.5 ismailia 00200 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
ahmed medhat elmazzahy ring road kilo 4.5 ismailia Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine suez canal university ring road kilo 4.5 ismailia Egypt University
COLLABORATORS
Name Street address City Postal code Country
Zakia Mahdy abolill ring road kilo 4.5 ismailia Egypt
Elham Hussien Madny ring road kilo 4.5 ismailia Egypt
Ahmed Abdelmeniem Abo elroose ring road kilo 4.5 ismailia Egypt
Hanan Mohamed Ghoneim ring road kilo 4.5 ismailia Egypt
ahmed medhat elmazzahy ring road kilo 4.5 ismailia Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator zakia abolill zakiamahdyaboloii@yahoo.com 00201007537438 ring road, kilo 4.5
City Postal code Country Position/Affiliation
ismailia 00200 Egypt professor
Role Name Email Phone Street address
Public Enquiries omima taha omimatharwat@yahoo.com 0020123423685 ring road, kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt lecturer
Role Name Email Phone Street address
Scientific Enquiries omima taha omimatharwat@yahoo.com 0020123423685 ring road, kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes data sharing will be through the data available in the study Study Protocol at the time of research submission i do not know this
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.dropbox.com/s/1ivj8839bwoi7fq/protocol.pdf?dl=0 Yes Pregnancy rates, endometrial thickness and number of follicles were significantly higher in the study group. Side effects showed significant difference between the study group (42.5%) and the control group (22.5), Among patients in the study group, the most common side effect was headache which was found in 8 patients (20%) then flushing in 5 patients (12.5%), 2 patients (5%) had blurring of vision. 23/07/2019 23/07/2019
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks https://www.dropbox.com/s/1ivj8839bwoi7fq/protocol.pdf?dl=0
Changes to trial information