comparison of the IVF outcome following ovarian aspiration and sclerotherapy and cases without this protocol in primary and recurrent
endometrioma.
Design
two arm parallel group blinded randomised clinical trial with 40 patient in control and 40 in the intervention group.
Settings and conduct
AFC and size of their endomerioma and AMH, FSH, Estradiol and CA125 is measured. patients are randomly divided into two control and intervention groups. in intervention group of infertile patients of Shariati hospital with history of primary or recurrent endometriosis, cyst content is aspirated and substituted by 98% ethanol and then reaspirated. patients are discharged with ampule of Diphereline. if patients are free from cyst and their endometrial thickness(ET) is less than 4mm, ovulation induction is started.In control group also, Diphereline is prescribed. after the dose if their ET is less than 4mm, ovulation induction is started. 2 weeks after embryo transfer, serum B-hcG in both groups are measured and if it is positive, TVS is ordered in 3 weeks time and in case of observation of fetal heart rate, this is considered a positive clinical pregnancy.
Participants/Inclusion and exclusion criteria
infertile, 20 to 40 years old female with endometrioma with exclusion criteria of: liver, kidney or heart diseases. endometrioma larger than 10 centimeter(cm) or smaller than 3cm with a thickened wall and suspicious for malignancy.
Intervention groups
after sclerotherapy, ampule of Diphereline is prescribed. if patients are free from ovarian cyst and their endometrial thickness(ET) is less than 4mm, ovulation induction is started.In control group also, after last dose if their ET is less than 4mm, ovulation induction is started.
Main outcome variables
Fertility rate
Pregnancy Rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191206045629N1
Registration date:2020-05-06, 1399/02/17
Registration timing:registered_while_recruiting
Last update:2020-05-06, 1399/02/17
Update count:0
Registration date
2020-05-06, 1399/02/17
Registrant information
Name
leila shahsavari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2206 8580
Email address
shahsavari_l@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-18, 1399/01/30
Expected recruitment end date
2020-07-20, 1399/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of aspiration and Ethanol sclerotherapy in primary and recurrent endometrioma on IVF outcome
Public title
Efficacy of aspiration and Ethanol sclerotherapy in primary and recurrent endometrioma on IVF outcome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
all infertile women in shariati hospital, in 20-40 year age interval with primary or recurrent endometrioma
Exclusion criteria:
having or history of hepatic
having or history of renal
having or history of cardiac diseases
having or history of any endometrioma larger than 10 cm and smaller than 3 cm
having or history of any cyst with thickened wall
suspicious for malignancy
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will be informed of the possibility of a new intervention to increase the likelihood of fertility, but no information will be given on which of the patients will be given this operation. Due to the fact that therapists were unaware of the possible intervention, blinding was performed. Double-blinding was not feasible in this study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of tehran university of medical sciences
Street address
Tehran-saadat abad- bulvard 24 meter- dasht behesh- between 4th and 5th west street#6 frist floor
City
Tehran
Province
Tehran
Postal code
1998683611
Approval date
2019-04-16, 1398/01/27
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.019
Health conditions studied
1
Description of health condition studied
Ovarian endometrioma
ICD-10 code
N80.1
ICD-10 code description
Endometriosis of ovary
Primary outcomes
1
Description
Fertility rate/ Pregnancy Rate
Timepoint
at the end of study
Method of measurement
observation of fetal heart activity by ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 2 to 3 days after the termination of menstruation, in the operating room under conscious sedation and in the lithotomy position, under the ultrasound guidance, ovarian cyst content is aspirated. afterward, 80% of the aspirated volume of cyst is substituted by 98% ethanol for 15 minutes and then aspirated.
Category
Treatment - Surgery
2
Description
Control group: Intervention group: 2 to 3 days after the termination of menstruation, in the operating room under conscious sedation and in the lithotomy position, under the ultrasound guidance, ovarian cyst content is aspirated. afterward, 80% of the aspirated volume of cyst is substituted by Normal saline for 15 minutes and then aspirated.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Ashraf aleyasin
Street address
north kargar street, jalal al ahmad avenue
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Fax
+98 21 8863 3039
Email
shariatihospital@tums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Sahraeian
Street address
north kargar street, jalal alahmad avenue, shariati hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
alyasina@tums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Leila shahsavari
Position
obstetrics and gynecology resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
saadat abad, bulvard 24 meter, dashte behesh, between 4th and 5th street#6 first floor
City
Tehran
Province
Tehran
Postal code
1998683611
Phone
+98 21 2206 8580
Email
shahsavari_l@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
ashraf aleyasin
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
north kargar street, jalal al ahmad avenue,shariati hospital
City
tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
alyasina@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
leila shahsavari
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
saadat abad.24 meter bulvard. dashte behesht between 4rth and 5th west street #6 first fllor
City
tehran
Province
Tehran
Postal code
1998683611
Phone
+98 21 2206 8580
Email
shahsavar_l@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available