Comparison of coasting with cabergoline administration for prevention of early severe Ovarian Hyper Stimulation Syndrome in Assisted Reproductive Technology cycles
We aim to compare coasting and Cabergoline administration in clinical pregnancy rate and prevention of severe Ovarian Hyper Stimulation Syndrome (OHSS). Materials and Methods: A total of 60 patients with In Vitro Fertilization (IVF)/Intra Cytoplasmic Sperm Injection (ICSI) cycles who are at risk of developing OHSS are selected. The definition of risk is: the presence of pre- ovulatory follicles ≥ 20 in both ovaries. Patients will be divided into two groups randomly. For 30 patients in coasting group, exogenous gonadotropins will be withheld to allow E2 to decrease while GnRH-a will be maintained. Then 10,000 Unit hCG will be administrated and oocyte retrieval will be performed 36 hours later. In Cabergoline group, for 30 patients, hCG will be administered and they receive 0.5 mg per day cabergoline orally from the day of hCG for 8 days. Luteal phase will be supported by administration of progesterone in oil 100mg per day for 14 days. In this study implantation rate, clinical pregnancy rate and incidence of Severe OHSS will be compared in both groups
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138706091132N1
Registration date:2008-12-25, 1387/10/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2008-12-25, 1387/10/05
Registrant information
Name
Abbas Aflatoonian
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35182470856
Email address
aflatoonian@yazdivf.org
Recruitment status
Recruitment complete
Funding source
Research Deputy of Yazd University of Medical Sciences.
Expected recruitment start date
2006-07-01, 1385/04/10
Expected recruitment end date
2007-07-01, 1386/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of coasting with cabergoline administration for prevention of early severe Ovarian Hyper Stimulation Syndrome in Assisted Reproductive Technology cycles
Public title
Comparison of coasting with cabergoline administration for prevention of early severe Ovarian Hyper Stimulation Syndrome in Assisted Reproductive Technology cycles
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients with In Vitro Fertilization (IVF)/Intra Cytoplasmic Sperm Injection (ICSI) cycles who are at risk of developing OHSS. The definition of risk is: the presence of pre- ovulatory follicles ≥ 20 in both ovaries.
Age
From 20 years old to 38 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
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
1
Registry name
Secondary trial Id
Registration date
2017-11-21, 1396/08/30
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Research and Clinical Center for Infertility, Yazd University of Medical Scienc
Street address
Bouali Ave, Safaeyeh
City
Yazd
Postal code
8916877391
Approval date
empty
Ethics committee reference number
1581
Health conditions studied
1
Description of health condition studied
Ovarian Hyperstimulation Syndrome
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Incidence of Severe OHSS
Timepoint
2 weeks
Method of measurement
Clinical Management
Secondary outcomes
1
Description
Implantation Rate
Timepoint
2 weeks
Method of measurement
Number of gestational sacs per embryo transferred
2
Description
Clinical Pregnancy Rate
Timepoint
2 weeks
Method of measurement
Embryonic cardiac activity observed by ultrasound
Intervention groups
1
Description
In coasting group, exogenous gonadotropins will be withheld to allow E2 to decrease while GnRH-a will be maintained. Then 10,000 Unit hCG will be administrated and oocyte retrieval will be performed 36 hours later. Luteal phase will be supported by administration of progesterone in oil 100mg per day for 14 days
Category
Prevention
2
Description
In Cabergoline group, hCG will be administered and they receive 0.5 mg per day cabergoline orally from the day of hCG for 8 days. Luteal phase will be supported by administration of progesterone in oil 100mg per day for 14 days.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Research and Clinical Center for Infertility, Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Abbas Aflatoonian
Street address
Bouali ave, Safaeyeh
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research and Clinical Center for Infertility, Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Abbas Aflatoonian
Street address
Bouali Ave, Safaeyeh
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Clinical Center for Infertility, Yazd Shahid Sadoughi 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
Research and Clinical Center for InfertilityوYazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
abbas aflatoonian
Position
Head/professor
Other areas of specialty/work
Street address
BouAli ave, safaeyeh
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
abbas_aflatoonian@yahoo.com
Web page address
www.yazdivf.org
Person responsible for scientific inquiries
Contact
Name of organization / entity
Research and Clinical Center for InfertilityYazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Abbas Aflatoonian
Position
head/professor
Other areas of specialty/work
Street address
Bouali Ave, Safaeyeh
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
aflatoonian@yazdivf.org
Web page address
www.yazdivf.org
Person responsible for updating data
Contact
Name of organization / entity
Research and Clinical Center for Infertility, Yazd Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Nasim Tabibnejad
Position
research consultant/ physician
Other areas of specialty/work
Street address
Bouali ave, safaeyeh
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 8121
Fax
+98 35 1824 7087
Email
nasimtabib@yahoo.com
Web page address
www.yazdivf.org
Sharing plan
Deidentified Individual Participant Data Set (IPD)