Determination of ASA effect on incidence and severity of OHSS in patients undergoing IVF
Design
A phase 2 interventional study consisted of intervention group (20 patients) recruited based on inclusion criteria. Data of control group (20 patients) will be extracted from patients with same characteristics underwent IVF regimen (without ASA)
Settings and conduct
The study will be conducted in Kerman Afzalipoor Hospital. The intervention group will be administered low dose ASA two weeks before the start of menstural cycle and will recieve Cinnal-F on day 3 of the cycle and after 6 days, on 9th day of the cycle, vaginal sonography will be performe. As the follicle size reached 12 to 14 mm, antagonist will be administered and as the size of follicles reached 16-18 mm, 1 cc Buserelin and 5000 units of hcg will be administered and 36 hours later, ovarian punction will be done. Patients will be given charts to follow their OHSS related symptoms. Three days after the punction, laboratory and sonographic data will be obtained and evaluated.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Female patients planned to treat with anatgonist protocol ART (Assisted Reproductive Technology)
Having PCO criteria (Including AMH level more than 4 ng/ml, Sonogram suggestive of PCO, and Oligomenorrhea)
Exclusion : Lack of consent to participate
Intervention groups
Patients will be administered low dose ASA 80 mg 2 weeks before their menstural cycle
Main outcome variables
OHSS incidence and Severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210730052019N2
Registration date:2021-08-28, 1400/06/06
Registration timing:registered_while_recruiting
Last update:2021-08-28, 1400/06/06
Update count:0
Registration date
2021-08-28, 1400/06/06
Registrant information
Name
Mehran Ilaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3251 7779
Email address
mehran-ilaghi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-25, 1400/06/03
Expected recruitment end date
2021-09-11, 1400/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of low-dose aspirin before IVF to prevent ovarian hyperstimulation syndrome (OHSS)
Public title
Effect of low-dose aspirin on OHSS
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Female patients planned to treat with anatgonist protocol ART (Assisted Reproductive Technology)
Having PCO criteria (Including AMH level more than 4 ng/ml, Sonogram suggestive of PCO, and Oligomenorrhea)
Exclusion criteria:
Lack of consent to participate
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
The intervention group will be recruited in this study. For the control group, existing data will be used. The control group in this study consists of patients with PCO criteria who had previously undergone IVF with the same regimen as Intervention group (Except for ASA). Data of this group is extracted from patients files in infertility ward of Kerman Afzalippor Hospital and will be used as the control to compare the outcomes of OHSS in intervention group. These patients, regarding the aforementioned criteria, will be selected using random sampling. Therefore, in this study, patient recruitment will occur for intervention group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Kerman University of Medical Sciences
Street address
Haftbagh-Alavi highway, Kerman University of medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2020-05-12, 1399/02/23
Ethics committee reference number
IR.KMU.AH.REC.1399.018
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
OHSS Incidence
Timepoint
Throughout the study based on patients symptoms or on the third day after punction based on laboratory and sonographic findings
Intervention group: The study will be conducted in Kerman Afzalipoor Hospital. The intervention group will be administered low dose ASA two weeks before the start of menstural cycle and will recieve Cinnal-F on day 3 of the cycle and after 6 days, on 9th day of the cycle, vaginal sonography will be performe. As the follicle size reached 12 to 14 mm, antagonist will be administered and as the size of follicles reached 16-18 mm, 1 cc Buserelin and 5000 units of hcg will be administered and 36 hours later, ovarian punction will be done. Patients will be given charts to follow their OHSS related symptoms. Three days after the punction, laboratory and sonographic data will be obtained and evaluated.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipour hospital
Full name of responsible person
Victoria Habibzadeh
Street address
Imam Khomeini highway, Afzalipoor hospital
City
Kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Phone
+98 34 3132 8000
Email
afzalipoorhospital@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Davood Kalantar
Street address
Haftbagh alavi highway, Kerman University of Medical Sciences
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
vcr@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Victoria Habibzadeh
Position
Professor, Obstetrics and gynecology specialist
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
imam khomeini highway, Afzalipoor Hospital
City
kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Phone
+98 34 3132 8000
Email
v_habibzadeh@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Victoria Habibzadeh
Position
Professor, Obstetrics and gynecology specialist
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
imam khomeini highway, Afzalipoor Hospital
City
kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Phone
+98 34 3132 8000
Email
v_habibzadeh@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Victoria Habibzadeh
Position
Professor, Obstetrics and gynecology specialist
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
imam khomeini highway, Afzalipoor Hospital
City
kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Phone
+98 34 3132 8000
Email
v_habibzadeh@kmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available