1)Objective:The aim of this study is to compare quinagolide with ِDostinex in the
prevention of ovarian hyperstimulation syndrome (OHSS).
2)Design:The study is a randomized clinical trial recruiting 126 patients, who have undergo assisted reproductive procedure. The study is conducting in the institu Infertility of shahid Beheshti.
3)Setting and conduct: All of the participants undergo controlled ovarian hyperstimulation (COH) with Gonadotropin/GnRH-antagonist protocol using recombinant-FSH. After 5 day stimulation when at least two follicles with diameter of 14mm observe, GnRH antagonist (Cetratide ,Merc)or( Orgalotrone ,Organon ) start with a daily dose 0.25mg until administer GnRH agonist as a final oocyte maturation. The participants divide in two groups. The first group comprise 63 women treat with 0.5mg of Dostinex (Pfyzer) every day for seven days commencing on the day of oocyte retrival. If OHSS occurre, the standard conservative and supportive management for OHSS employe. The second group comprise of 63 women, the latter group receive Quinagolide 75 mg (Norprolac, Ferring, Denmark). Diagnosis of OHSS as well as its severity performe according to a standard definition 3 and 6 dayes after GnRH agonist administration.
4)Participants including major eligibility criteria:
inclusion criteria: 20-40 years old patient; 20 oocytes when agonist GnRh start; risk of OHSS
Exclusion criteria: metabolic dysfunction; hypertension; history of syncope and heart disease.
5)Intervention:first group treat with 0.5mg of Dostinex (Pfyzer) every day for 7 days commencing on the day of oocyte retrival ,the second group comprise of 63 women, the latter group receive 75mg of Quinagolide for 7 days commencing on the day of oocyte retrival.
6)Variables: nausea and vomiting; abdominal distention; hemoconcentration; ascit
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016053128187N1
Registration date:2017-03-04, 1395/12/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-03-04, 1395/12/14
Registrant information
Name
Mahshid Vasef
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7343 3000
Email address
vasef@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Infertility & Reproductive Health Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
Expected recruitment start date
2016-12-05, 1395/09/15
Expected recruitment end date
2017-03-02, 1395/12/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomaized clinical trial to compare Dostinex versus Quinagolide to prevention of ovarian hyperstimulation syndrome
Public title
Dostinex versus Quinagolide for prevention of ovarian hyperstimulation syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 20-40 years old patient; 20 oocytes when agonist GnRh start;risk of OHSS
Exclusion criteria: metabolic dysfunction; hypertension; history of syncope; heart disease.
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
126
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Infertility & Reproductive Health Research Center, Shahid Beheshti University o
Street address
Infertility and Reproductive Health Research Center, Shohada-e-Tajrish Hospital, Tajrish Sq, Tehran
City
Tehran
Postal code
Approval date
2016-11-13, 1395/08/23
Ethics committee reference number
ir.sbmu.retech.rec.1395.542
Health conditions studied
1
Description of health condition studied
Ovarian hyperstimulation syndrom
ICD-10 code
N98.1
ICD-10 code description
Hyperstimulation of ovaries
Primary outcomes
1
Description
Nausea and vomiting
Timepoint
3 and 6 days after drug prescription
Method of measurement
Questionnaire
2
Description
Abdominal distention
Timepoint
3 and 6 days after drug prescription
Method of measurement
Questionnaire and physical examination
3
Description
Hemoconcentration
Timepoint
3 and 6 days after drug prescription
Method of measurement
Clinical lab
4
Description
Ascit
Timepoint
3 and 6 days after drug prescription
Method of measurement
Sonography
Secondary outcomes
1
Description
Tap of ascit
Timepoint
3 and 6 days after drug prescription
Method of measurement
paracentesis
2
Description
Hospitalization
Timepoint
3 and 6 days after drug prescription
Method of measurement
Questionnaire
Intervention groups
1
Description
The first group treat with 0.5mg of Dostinex every day for seven days commencing on the day of oocyte retrival.
Category
Treatment - Drugs
2
Description
The second group treat with 75 mg of Quinagolid every day for 7 days commencing on the day of oocyte retrival.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility & Reproductive Health Research Center, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.R .Taheripanah. Infertility & Reproductive Health Research Center(IRHRC) Board of Iranian Society
Street address
Infertility and Reproductive Health Research Center, Shohada-e-Tajrish Hospita, Tajrish Sq, Tehran
City
Tahran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Sadeghzadeh
Street address
Infertility and Reproductive Health Research Cente, Shohada-e-Tajrish Hospita, Tajrish Sq, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahid Beheshti 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
Infertility & Reproductive Health Research Center,Shahid Beheshti University of Medical Sciences
Full name of responsible person
Zahra Sadeghzadeh
Position
Bachelor of Psychology
Other areas of specialty/work
Street address
Infertility and Reproductive Health Research Center, Shohada-e-Tajrish Hospita, Tajrish Sq, Tehran
City
Tehran
Postal code
1989934148
Phone
+98 21 2271 2234
Fax
+98 21 2272 4215
Email
irhrc@yahoo.com
Web page address
http://irhrc.sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Infertility & Reproductive Health Research Center, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr.R .Taheripanah
Position
Fellowship of infertility
Other areas of specialty/work
Street address
Infertility and Reproductive Health Research Cente, Shohada-e-Tajrish Hospita, Tajrish Sq, Tehran