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.: PACTR202010622528145 Date of Approval: 15/10/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Dienogest vs. Laparoscopic Cystectomy for Ovarian Endometrioma in Females Attending Outpatient Clinic in Suez Canal University Hospital
Official scientific title Dienogest vs. Laparoscopic Cystectomy for Ovarian Endometrioma in Females Attending Outpatient Clinic in Suez Canal University Hospital
Brief summary describing the background and objectives of the trial Endometriosis is a benign, chronic inflammatory condition characterized by the presence and growth of endometrial implants outside the uterine cavity (Vercellini et al., 2009). It preferentially occurs on pelvic organs and the peritoneum, whereas extra-abdominal endometriosis is rare (Pontis et al., 2014 and Melis et al., 2005). The etiology is not precisely understood, but it is likely multifactorial (Jones et al., 2009, Locci et al., 2013). The quality of life and sexual health are strongly impaired, and sufferers in many cases develop psychological symptoms (Melis et al. 2014 and Angioni et al., 2015). The correct and most suitable treatment for a patient is a very difficult choice to make. Different surgical approaches have been proposed for the management of pain and fertility (Angioni et al., 2006 and Angioni et al., 2010). However, due to the high rates of recurrences, the possible complications related to multiple surgeries and the potentially detrimental effects on fertility, the role of medical treatment is still very important (Pisanu et al., 2010 and Angioni et al., 2015).
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: Surgery
Anticipated trial start date 01/11/2020
Actual trial start date
Anticipated date of last follow up 31/07/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
Recruitment status Active, not recruiting
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group dienogest group dienogest (VisanneVR , Bayer AG, Soficopharm) (2mg/day) starting on the first day of the first menstrual cycle daily for 3 months. 3 months dienogest (VisanneVR , Bayer AG, Soficopharm) (2mg/day) starting on the first day of the first menstrual cycle daily for 3 months. 60 Active-Treatment of Control Group
Experimental Group surgery group laparoscopic ovarian cystectomy follow up after 3 months of surgery laparoscopic ovarian cystectomy 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Unilateral endometrioma  Size 3-8 cm  Age 18-45 years  Regular cycles  No previous ovarian operations in the last 3 months Amenorrhea for 2 or more years  Suspected or confirmed malignancy  Women within 2 years of menarche  Women on progesterone or combined estrogen and progestin contraception  Menopause  Pregnancy Adult: 19 Year-44 Year 19 Year(s) 44 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 27/07/2020 research ethics committee faculty of medicine suez canal university
Ethics Committee Address
Street address City Postal code Country
ring road kilo 4.5 Ismailia 41522 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To evaluate the ovarian reserve in patients with ovarian endometriomas after being classified into two groups ( those who will receive medical treatment (dienogest) versus those who will undergone surgical treatment (laparoscopic cystectomy) ). 3 months
Secondary Outcome To evaluate the effect of medical treatment (dienogest) as a treatment for ovarian endometriomas on a) patient satisfaction, b) pain relief by B&B scale., c)side effects, d) quality of life, and e) recurrence rate. - To evaluate the effect of laparoscopic cystectomy as a surgical treatment for ovarian endometriomas on a) patient satisfaction, b) pain relief by B&B scale., c)side effects, d) quality of life, and e) recurrence rate. to determine factors associated with decline in ovarian reserve after surgical excision of endometrioma. to determine factors associated with recurrent endometrioma after surgical excision 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of medicine suez canal university round road kilo 4.5 ismailia Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
eman bassiouny ring road kilo 4.5 ismailia Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor suez canal university ring road kilo 4.5 ismailia Egypt University
COLLABORATORS
Name Street address City Postal code Country
eman bassiouny ring road, kilo 4.5 ismailia Egypt
khaled atwa ring road, kilo 4.5 ismailia Egypt
Omima Tharwat Taha ring road, kilo 4.5 ismailia Egypt
zakia mahdy ibrahim ring road, kilo 4.5 ismailia Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator eman bassiouny eman.mohammad60@yahoo.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
Role Name Email Phone Street address
Public Enquiries omima taha omimatharwat@yahoo.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
Role Name Email Phone Street address
Scientific Enquiries omima taha omimatharwat@yahoo.com 01223423685 ring road kilo 4.5
City Postal code Country Position/Affiliation
ismailia Egypt suez canal university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes data sharing will be through the uploaded results and after approval of our research ethics committee Study Protocol after completion of the study after approval of the research ethics committee
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