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.: PACTR202210557026698 Date of Approval: 24/10/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Spontaneous pregnancy rate after hysterosalpingography (HSG) versus saline infusion sonogram done under high pressure (SIStreat(
Official scientific title Spontaneous pregnancy rate after hysterosalpingography (HSG) versus saline infusion sonogram done under high pressure (SIStreat(
Brief summary describing the background and objectives of the trial Failure to achieve conception after 12 months of regular unprotected intercourse is defined as infertility.(1) As there are so many causes of delayed conception, mostly known and some still unclear, tubal factor has increased since the last decade, reached up to 30-35% of cases.(2) checking tubal patency is an essential step in the investigations done for sub-fertile couples and is typically performed using hysterosalpingography (HSG) or laparoscopy with chromotubation.(3) Both HSG and diagnostic laparoscopy (DL) are painful procedures, with well-known hazards of exposure to iodinated X-ray contrast media and ionizing radiation in HSG and possible anesthesia or operative complications in DL.(4) To overcome these disadvantages, during the last two decades contrast sonography (Hy-CoSy) and saline infusion sonogram (SIS) have been used as alternatives in many countries. One advantage of these techniques is the absence of radiation; another is that these procedures can be performed in an outpatient clinic by a gynecologist. Several studies have shown that the methods have nearly equal sensitivity and specificity compared with laparoscopy as the gold standard for tubal patency checking. (5,6) Recently, SIS was used as the main step for the assessment of fallopian tube patency, because of its simplicity, safety, and high tolerability with a very low risk of complications, like failure to complete the procedure(7%), pelvic pain (3.8%), vagal symptoms (3.5%), nausea (1%), and post procedure fever (0.8%). (7) Aim of the work The aim of this study is to compare between Spontaneous pregnancy rate after hysterosalpingography (HSG) versus saline infusion sonogram done under high pressure (SIStreat) in women suffering from infertility.
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 01/03/2020
Actual trial start date 01/04/2020
Anticipated date of last follow up 01/04/2021
Actual Last follow-up date 31/03/2021
Anticipated target sample size (number of participants) 227
Actual target sample size (number of participants) 183
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 by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group saline infusion sonogram done under high pressure SIStreat once 5 minutes all patients started to perform the conventional SIS, using a sterile pediatric Foley catheter (10 f) inserted through cervical canal, a Toomey syringe attached to the outer end of the catheter, filled with 60 ml of sterile saline solution then a transvaginal ultrasonic probe was inserted into the posterior vaginal fornix. In the beginning, the classical SIS was performed: saline was slowly infused to the extent that would distend the uterus, tubal patency was checked under low pressure that just permit proper visualization. Observing fluid in the cul de sac was considered an indication of tubal patency (at least one tube) and the condition of the tubes were diagnosed as patent under low pressure. Patient with tubes patent under low pressure were identified as "group B1". Women with tubes diagnosed as occluded under low pressure were subjected (SIStreat) immediately, by gradual increasing the infusion pressure using the Toomey syringe (9), until fluid appeared in the cul de sac or for 5 minutes, otherwise the tubes were diagnosed as occluded under high pressure. The tubal status was checked and recorded as patent (one or both tubes) or occluded (both tubes). 90
Control Group hystrosalpengiogram once 5 minutes HSG in radiology department, using water-soluble contrast material WSCM (52.7% diatrizoate meglumine and 26.8% iodipamide meglumine, Sinografin; Bracco Diagnostics, New Brunswick, NJ). Balloon catheters were placed in the uterus and the mean amount of WSCM use was 20 mL (range, 10–35 mL). The tubal status was checked and recorded as patent (one or both tubes) or occluded (both tubes). 93 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
women suffering from of primary or secondary infertility for one year or more, normal ovarian and uterine factors, Normal semen analysis. women elder than 40 or less than 18, any uterine abnormalities, Ovulation failure, FSH > 15 mIU/ mL, Known tubal occlusion Abnormal semen analysis 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 20/02/2020 ethics committee Alexandria university
Ethics Committee Address
Street address City Postal code Country
Raml station , Alexandria Egypt Alexandria 002 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome opening the oviducts using HSG or SIStreat, evidenced by the presence of dye or saline in pouch of Douglas that was detected by X-ray or TV-US respectively immediately
Secondary Outcome the existence of spontaneous clinical pregnancy within the following period of six months. The diagnosis was confirmed by a sonographically visible intrauterine gestational sac. within 6 mounths
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
elshatby maternity hospital El-Shatby University hospital, EL Shatby, Alexandria, Egypt Alexandria Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alexandria university Raml station Alexandria Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Alexandria university Raml station , Alexandria Alexandria Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator suzan El sharkawy S_AbdelRahim00@Alexmed.edu.eg 00201090052715 wekala street
City Postal code Country Position/Affiliation
Damanhour Egypt assistant professor Alexandria university
Role Name Email Phone Street address
Public Enquiries samia mohamed ssamir@alexu.edu.eg 00201002375636 sanhour
City Postal code Country Position/Affiliation
Damanhour Egypt lecturer Alexandria university
Role Name Email Phone Street address
Scientific Enquiries suzan samir samirsuzan6@gmail.com 00201090052715 wekala
City Postal code Country Position/Affiliation
Damanhour Egypt assistant prof Alexandria university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes patients study data will be available upon request on private bases Study Protocol for 1 year by requesting the authors through 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