In this randomized clinical trial, study preventive description of Cabergoline will be compared with Albumin 20% in high risk women for ovarian hyperstimulation syndrome (OHSS) in 130 women. We use a down regulation protocol with a GnRH agonist (Buserelin acetate) as a long protocol for ICSI/ IVF-ET. The inclusion criteria are the development of 20–30 follicles larger than 12 mm in diameter in sonographic evaluation and retrieval of more than 20 oocytes. The exclusion criteria are coasting cases and age more than 37 years. The patients are allocated using a computerized randomization method into two equal groups after the oocytes retrieval to receive human albumin 20% infusion or Cabergoline tablet (0.5 mg) daily for 6 days 30 minutes after oocytes retrieval. The patients will be evaluated 6 days after ET by ultrasonographic examination for ovarian size and detection of ascites. Incidence and severity of OHSS will be assessed using Golan et al 1989 and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138808271141N7
Registration date:2010-01-04, 1388/10/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-01-04, 1388/10/14
Registrant information
Name
Kiandokht Kiani
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2230 7960
Email address
kiandokht.kiani@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Royan Institute
Expected recruitment start date
2009-08-23, 1388/06/01
Expected recruitment end date
2010-01-21, 1388/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of Cabergoline in preventing ovarian hyper stimulation in ART program
Public title
The efficacy of Cabergoline in preventing ovarian hyper stimulation in ART program
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: risk of developing OHSS, defined by the development of 20–30 follicles larger than 12 mm in diameter and retrieval of more than 20 oocytes, ovarian stimulation with long protocol Exclusion Criteria: Coasting cases, age more than 37 years, previous pelvic surgery, Intramural or submucosal myoma sizes > 5 CM, uterine polyps, Smoking, or alcohol addiction
Age
From 15 years old to 37 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
130
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
Royan institute
Street address
Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
City
Tehran
Postal code
19395-4644
Approval date
2009-07-28, 1388/05/06
Ethics committee reference number
EC/1020
Health conditions studied
1
Description of health condition studied
ovarian hyperstimulation syndrome
ICD-10 code
O94, O99
ICD-10 code description
Other obstetric conditions, not elsewhere classified
Primary outcomes
1
Description
OHSS occurrence rate and severity of OHSS in two groups
Timepoint
6 days after embryos transfer(ET)
Method of measurement
accordance with the Golan 5 grade system
Secondary outcomes
1
Description
pregnancy and early miscarriage rates
Timepoint
5 week after embryo transfer until 12 gestational weeks
Method of measurement
Sonography
Intervention groups
1
Description
Gabergoline tablet (0.5 mg) daily until 6 days after oocytes retrieval
Category
Treatment - Drugs
2
Description
Human albumin 20% infusion
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Royan Institute
Full name of responsible person
Dr.Tehraninejad
Street address
Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Royan Institute
Full name of responsible person
Dr. Vosoogh
Street address
Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Royan Institute
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
Royan institute
Full name of responsible person
Arezoo Arabipour
Position
MSc of midwifery
Other areas of specialty/work
Street address
Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
City
Tehran
Postal code
19395-4644
Phone
+98 21 2356 2307
Fax
+98 21 2230 6481
Email
arezoo.arabipoor@gmail.com
Web page address
www.royaninstitute.org
Person responsible for scientific inquiries
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Ensieh Tehraninejad MD
Position
MD
Other areas of specialty/work
Street address
Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
City
Tehran
Postal code
19395-4644
Phone
+98 212362307
Fax
+98 21 2230 6481
Email
Tehraninejad@royaninstitute.org
Web page address
www.royaninstitute.org
Person responsible for updating data
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Eniseh Tehraninejad
Position
MD
Other areas of specialty/work
Street address
Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
City
Tehran
Postal code
19395-4644
Phone
+98 21 2356 2307
Fax
+98 21 2230 6481
Email
Tehraninejad@royaninstitute.org
Web page address
www.royaninstitute.org
Sharing plan
Deidentified Individual Participant Data Set (IPD)