This study is a prospective randomized clinical trial to assess the efficacy of the Methylprednisolone for preventing ovarian hyperstimulation syndrome in IVF cycles. The study population comprises all infertile patients, aged 18-35 years old with diagnosis of polycystic ovarian syndrome that will undergo in-vitro fertilization. In this study all eligible patients will be randomly allocated into two study groups by a computerized randomization method. Treatment group will received 16 mg Methylprednisolone initiated from the first day of stimulation and tapered after the first pregnancy test (day 13 after the embryo transfer). Furthermore, these patients will receive 1 gram IV bolous dose of Methylprednisolone, on the day of egg collection and embryo transfer. Patients in the control group will not receive any treatment with Glucocorticoids. If each group confront with every kind of high risk signs or symptoms, they will undergo other preventional methods such as coasting or gonadotropin withdrawal. The presence of OHSS is defined in accordance with the Golan 5 grade system.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138806181141N6
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
2009-10-23, 1388/08/01
Expected recruitment end date
2010-08-23, 1389/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Administration of methylprednisolone for prevention of ovarian hyperstimulation syndrome in in-vitro fertilization cycles
Public title
Administration of Methylprednisolone in prevention of ovarian hyperstimulation syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: 1.Poly Cystic Ovarian Syndrome patients 2.Indication for IVF/ICSI and Long Protocol ovarian stimulation 3.Age<35 4.Basal FSH≥10 5.Normal BMI (20-25) 6.Physical health Exclusion Criteria: 1. Allergy to GnRH analogues, FSH and corticosteroids 2. presence of heart failure, recent myocardial infarction, Hypertension, Diabetes mellitus, epilepsy, glaucoma, hypothyroidism, hepatic failure, osteoporosis, peptic ulceration, psychosis, or severe affective disorders and renal impairment. 3. Using drugs that have interaction with corticosteroids such as Cyclosporine, Phenobarbital, Phenytoin, Rifampin, Ketoconazole, Aspirin and Anticoagulants (All of these drugs shouldn’t be used during recent 2 weeks prior to the study and during corticosteroids consumption)
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
218
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
88/1030/EC
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
Timepoint
Until 20 days after embryos transfer (ET)
Method of measurement
accordance with the Golan 5 grade system
Secondary outcomes
1
Description
Estradiol concentration
Timepoint
on the day before hCG administration
Method of measurement
laboratory results
2
Description
Retrieved and injected oocytes number and quality
Timepoint
oocyte retrieval day
Method of measurement
embryology results
3
Description
Achieved and transferred embryos number and quality
Timepoint
48-72 hours after oocyte retrieval
Method of measurement
embryology results
4
Description
Chemical pregnancy rate
Timepoint
day 13 after embryo transfer
Method of measurement
laboratory results
5
Description
Clinical pregnancy rate
Timepoint
4 weeks after embryo transfer
Method of measurement
Ultrasound results
6
Description
Implantation rate
Timepoint
4 weeks after embryo transfer
Method of measurement
Ultrasound results
7
Description
Cancellation rate
Timepoint
day 13 after embryo transfer
Method of measurement
patient records
Intervention groups
1
Description
routine treatment for prevention of OHSS
Category
Treatment - Drugs
2
Description
Methylprednisolone 16mg/daily orally, until 5 weeks plus 1 gm IV injection on retrieval and embryo transfer day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Royan Institute
Full name of responsible person
Dr.moini
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.Vosough
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
Ladan Mohammadi Yeganeh
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
ladankh2004@yahoo.com
Web page address
www.royaninstitute.org
Person responsible for scientific inquiries
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Dr. Moini
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
a_moini@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
Dr. Moini
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
a_moini@royaninstitute.org
Web page address
www.royaninstitute.org
Sharing plan
Deidentified Individual Participant Data Set (IPD)