Background: Ovarian hyperstimulation syndrome (OHSS) is the most serious and potentially life‐threatening iatrogenic complication associated with ovarian stimulation during Assisted Reproductive Technology (ART) protocols. OHSS typically is a result of ovarian expression of vascular endothelial growth factor (VEGF) which increases vascular permeability .
Objective: comparison of albumin and cabergoline in the prevention of ovarian hyperstimulation syndrome.
Materials and Methods: 95 high risk infertile women for OHSS (more than 20 follicles in both ovaries at day of HCG injection) were randomly divided into two groups. First group including 48 women received 10 unit intravenous albumin at starting oocyte retrieval, and second group including 47 women received 0.5 mg/day dopamine agonist (cabergolin) at day of HCG injection till 8 days. The dosage of hMG used, total number of follicles developed, number of oocytes retrieved, serum E2 concentrations during the luteal phase, development of ascites, number of embryos generated clinical pregnancy rate, results of the IVF-ET cycles and incidence and severity of any OHSS were evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138706281217N4
Registration date:2013-07-21, 1392/04/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-07-21, 1392/04/30
Registrant information
Name
Fatemeh Vahidroodsari
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1841 7493
Email address
vahidroodsarif@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2009-04-21, 1388/02/01
Expected recruitment end date
2010-04-21, 1389/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Albumin and Cabergoline in the Prevention of Ovarian Hyperstimulation Syndrome
Public title
Comparison of Albumin and Cabergoline in the Prevention of Ovarian Hyperstimulation Syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criterion was the presence of >20 oocytes during oocyte retrieval, ovary size>10 cm, serum Estradiol >2500 pg/ml on the day of HCG administration.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
95
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences Ethics Committee
Street address
Mashhad University of Medical Sciences, Azadi square
City
Mashhad
Postal code
Approval date
2009-01-03, 1387/10/14
Ethics committee reference number
88182
Health conditions studied
1
Description of health condition studied
ovariab hyperstimulation
ICD-10 code
N99-N99
ICD-10 code description
بیماری های مربوط به دستگاه ادراری-تناسلی
Primary outcomes
1
Description
prevention of OHSS
Timepoint
from strat to 2 months later
Method of measurement
questionare
Secondary outcomes
1
Description
severity of OHSS
Timepoint
from start to 15 days later
Method of measurement
questionare
Intervention groups
1
Description
using of cabergulin and albumin
Category
Treatment - Drugs
2
Description
administration of cabergulin and alnumin
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Montaserieh infertility center
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Medical Faculty, Mashhad University of Medical Sciences
Full name of responsible person
Mahin Nghinia
Street address
Mashhad University of Medical Sciences, Azadi square
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Medical Faculty, Mashhad University of Medical Sciences
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
Montaserieh Ifertility center, Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Vahidroodsari
Position
Associated professor
Other areas of specialty/work
Street address
Ghaem hospital
City
Mashhad
Postal code
00985118412477
Phone
+98 51 1841 2477
Fax
Email
sabalanmountain@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ghaem hospital, Mashhad University of Medical Sciences
Full name of responsible person
Alieh Torabizadeh
Position
Associated professor
Other areas of specialty/work
Street address
Ghaem hospital
City
Mashhad
Postal code
Phone
+98 51 1841 2477
Fax
Email
torabiozadeha@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ghaem hospital
Full name of responsible person
Tooran Makhdoumi
Position
Researcher
Other areas of specialty/work
Street address
Department of Obstetrics and Gynecology, Ghaem hospital, Ahmadabad street
City
Mashhad
Postal code
Phone
+98 51 1841 2477
Fax
+98 51 1843 0596
Email
sabalanmountain@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)