30 patients as interventional group received transvaginal sclerotherapy for ovarian endometrioma .The needle is introduced into endometrioma and aspiration is done under sonographic guidance. The endometrioma is irrigated with sterile normal saline till the fluid is clear in color. The endometrioma is filled with 98% ethanol for 10 minute and at the end ethanol is aspirated. Then the patients are followed after one week and month. If the patients have no any endometrioma they are treated with IVF long protocol.30 patients as control group with endometrioma enrolled for IVF protocol who do not treated by ethanol sclerotherapy. Patients undergo pituitary desensitization with superfact (sc) at a dose of 0.4 µg/day starting in the mid luteal phase and after menstruation continued at a dose of 0.2 µg/day until 24 hours before the administration of U-HCG. Treatment with menogon is started at the second day of menstruation .The ovarian response is monitored by vaginal sonography and the dose is adjusted accordingly triggering of final follicular maturation with U- HCG is performed in the evening. Oocyte is retrieved by follicular aspiration 34-36 hrs after U-HCG. The number of oocyte retrieval and pregnancy rate are compared in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108024339N4
Registration date:2011-08-15, 1390/05/24
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2011-08-15, 1390/05/24
Registrant information
Name
Elham Rahmani
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77125265914
Email address
rahmani@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd research and clinical center for infertility
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the efficacy of aspiration of recurrent endometrioma and ethanol injection in IVF cycle
Public title
The efficacy of alcohol injection in endometrioma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:The patients have past history of operation of endometrioma but endometrioma is recurrented, FSH<10, 20<age<39, long protocol for IVF cycle.
Exclusion criteria: Other protocol for IVF cycle,FSH>10, 20>age>39, the patient with liver and kidney and heart disease, non recurrent endometrioma.
Age
From 20 years old to 39 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Yazd research and clinical center for infertility
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Postal code
8916877391
Approval date
2011-06-20, 1390/03/30
Ethics committee reference number
938
Health conditions studied
1
Description of health condition studied
endometriosis
ICD-10 code
N80.1
ICD-10 code description
اندومتریوز تخمدان
Primary outcomes
1
Description
the size of endometrioma
Timepoint
preoperation
Method of measurement
sonography
Secondary outcomes
1
Description
chemical pregnancy
Timepoint
14 days after embryo transfer
Method of measurement
serum BHCG
Intervention groups
1
Description
30 patients as interventional group received transvaginal sclerotherapy for ovarian endometrioma The needle is introduced into endometrioma and aspiration is done under sonographic guidance. The endometrioma is irrigated with sterile normal saline till the fluid is clear in color. The endometrioma is filled with 98% ethanol for 10 minute and at the end ethanol is aspirated. Then the patients are followed after one week and month. If the patients have no any endometrioma they are treated with IVF long protocol. Patients undergo pituitary desensitization with superfact (sc) at a dose of 0.4 µg/day starting in the mid luteal phase and after menstruation continued at a dose of 0.2 µg/day until 24 hours before the administration of U-HCG. Treatment with menogon is started at the second day of menstruation .The ovarian response is monitored by vaginal sonography and the dose is adjusted accordingly triggering of final follicular maturation with U- HCG is performed in the evening. Oocyte is retrieved by follicular aspiration 34-36 hrs after U-HCG. The number of oocyte retrieval and pregnancy rate are compared in both groups.
Category
Treatment - Drugs
2
Description
According to specific research criteria, the 30 patients with endometrioma are received IVF long protocol as control group Patients undergo pituitary desensitization with superfact (sc) at a dose of 0.4 µg/day starting in the mid luteal phase and after menstruation continued at a dose of 0.2 µg/day until 24 hours before the administration of U-HCG. Treatment with menogon is started at the second day of menstruation .The ovarian response is monitored by vaginal sonography and the dose is adjusted accordingly triggering of final follicular maturation with U- HCG is performed in the evening. Oocyte is retrieved by follicular aspiration 34-36 hrs after U-HCG. The number of oocyte retrieval and pregnancy rate are compared in both groups.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd research and clinical center for infertility
Full name of responsible person
Prof. Aflatoonian
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd research and clinical center for infertility
Full name of responsible person
Prof.Aflatoonian
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd research and clinical center for infertility
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd research and clinical center for infertility
Full name of responsible person
Dr.Elham Rahmani
Position
Obestetrics and Gynecologist,Student of fellowship
Other areas of specialty/work
Street address
یزد, صفائیه,خیابان بوعلی, مرکز تحقیقاتی و درمانی ناباروری یزد
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
Email
rahmani@bpums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd research and clinical center for infertility
Full name of responsible person
Prof.Aflatoonian
Position
Prof. of Obestetrics and Gynecologist, fellowship of infertility
Other areas of specialty/work
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
Email
aflatoonian@yazdivf.org
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)