Efficiency of low dose aspirin for prevention of ovarian hyper stimulation syndrome for in vitro fertilization cycles of the patient with polycystic ovarian syndrome
Goal: To evaluate the efficiency of low dose aspirin for prevention of ovarian hyper stimulation syndrome for in vitro fertilization cycles of the patient with polycystic ovarian syndrome (PCOS). Study population: Based on modified Roterdom criteria, 80 PCOS patients will be selected. Inclusion criteria: Polycystic ovarian syndrome (PCOS) will be confirmed by the presence of 1-Hyperandrogenism (clinical and/or biochemical), and 2-Ovarian dysfunction (oligo-anovulation and/or polycystic ovaries), and 3-The exclusion of other androgen excess or related disorders. Exclusion criteria: All of the patients with Known hypersensitivity to ASA or previous gastritis or GI bleeding will be excluded. Patients with PCOS who need IVF will be devided to 2 groups: 1- For the first group 100mg ASA will be started since the 21th day of the previous cycle. 2- for the second group placebo will be started since the 21th cycle day. Other steps of IVF protocol will be the same for both groups: Gonadotropin Releasing Hormone (GnRH) agonist starts from the 21th day of previuos cycle to the Human Chorionic Gonadotropin (HCG)-day. Human Menopausal Gonadotropin (HMG) and Gonal-f one ampul /day starts from the 2nd cycle day and follicl monitoring by ultrasound starts from the 6th cycle day. HCG is injected when the follicles reach the appropriate size and ovum pick up will be done. The total follicular count, serum estradiol level and ovarian size will be evaluated for the evidence of OHSS.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201105216541N1
Registration date:2011-06-18, 1390/03/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-06-18, 1390/03/28
Registrant information
Name
Bahia Namavar Jahromi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 2365
Email address
namavarb@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Infertility research center, Shiraz University of Medical Sciences
Expected recruitment start date
2011-05-01, 1390/02/11
Expected recruitment end date
2013-06-28, 1392/04/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficiency of low dose aspirin for prevention of ovarian hyper stimulation syndrome for in vitro fertilization cycles of the patient with polycystic ovarian syndrome
Public title
Efficiency of low dose aspirin for prevention of complications for in vitro fertilization cycles of the patient with polycystic ovarian syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: polycystic ovarian syndrome (PCOS) confirmed by: Hyperandrogenism (clinical and/or biochemical); Ovarian dysfunction (oligo-anovulation and/or polycystic ovaries); The exclusion of other androgen excess or related disorders.
Exclusion criteria: All of the patients with Known hypersensitivity to ASA or previous gastritis or GI bleeding.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comitee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences
City
Shiraz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
ct-89-5522
Health conditions studied
1
Description of health condition studied
polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
number of follicles
Timepoint
every 3-4 days
Method of measurement
by Ultra sound scan
2
Description
serum Estradiol
Timepoint
every 3-4 days
Method of measurement
serum level of Estradiol
Secondary outcomes
1
Description
ovarian size more than 5 cm
Timepoint
3-4 days
Method of measurement
ultra sound
2
Description
ovarian size more than12 cm
Timepoint
3-4 days
Method of measurement
ultra sound
Intervention groups
1
Description
For the intervention group 100mg/day asprin will be started since the 21th day of the previous cycle.
Category
Treatment - Drugs
2
Description
A placebo with a similar shape will be started for the control group since the 21th day of previous cycle.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility center of Ghadir Hospital
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Infertility research center, Shiraz university of Medical Sciences
Full name of responsible person
Dr. Jale Zolghadr
Street address
Dep. of OB-GYN, Shahid Faghihi Hospital, Zand street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Infertility research center, Shiraz 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 research center, Shiraz university of Medical Sciences
Full name of responsible person
Dr. Bahia Namavar Jahromi
Position
Associate professor
Other areas of specialty/work
Street address
Dep. of OB-GYN, Shahid Faghihi Hospital, Zand street
City
Shiraz
Postal code
Phone
+98 71 1233 2365
Fax
Email
namavarb@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Infertility research center, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Jale Zolghadr
Position
Associate professor
Other areas of specialty/work
Street address
Dep of OB-GYN, Shahid Faghihi Hospital, Zand street
City
Shiraz
Postal code
Phone
+98 71 1233 2365
Fax
Email
jzolghad@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)