Evaluation of efficacy of Letrozole on the duration and severity of Ovarian hyperstimulation syndrome
Design
A clinical trial with a control group, with parallel groups, blinded, randomized, phase 2 on 40. A random number table was used for randomization.
Settings and conduct
The study in the infertility ward of Afzalipour Hospital in Kerman was conducted as a clinical trial in 1399 (2020) in which 20 women who were in the IVF cycle and received ovarian stimulant drugs and the symptoms of ovarian hyperstimulation syndrome are considered as patients prone to severe ovarian hyperstimulation syndrome and are selected for inclusion in the study. These patients are scheduled to freeze all fetuses and are given 2.5 mg letrozole tablets daily for up to 10 days, and clinical and laboratory signs and symptoms are charted. On the other hand, another 20 women with the same characteristics as the 20 women in the case were selected as controls, except that they were routinely treated for severe ovarian hyperstimulation syndrome and were not given letrozole alone. Then, the two groups are then compared in terms of length of recovery and severity of ovarian hyperstimulation syndrome.
Participants/Inclusion and exclusion criteria
Enter condition : Having Ovarian hyperstimulation syndrome
Not enter condition : Lack of incidence of hyperstimulation syndrome after receiving ovarian stimulant drug due to infertility / Patient dissatisfaction to participate in the study
Intervention groups
Intervention group: Prescription of Letrozole tablet 2.5 mg from Abu Reihan company orally daily for 10 days along with routine treatment of ovarian hyperstimulation syndrome
Control group: Evaluation of tests and sonograghy of the control group based on the case that they have received only routine treatment of ovarian hyperstimulation syndrome.
Main outcome variables
Duration of Ovarian hyperstimulation syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141008019464N2
Registration date:2020-12-21, 1399/10/01
Registration timing:retrospective
Last update:2020-12-21, 1399/10/01
Update count:0
Registration date
2020-12-21, 1399/10/01
Registrant information
Name
Victoria Habibzadeh
Name of organization / entity
Kerman University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 342322250
Email address
v_habibzadeh@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-22, 1398/06/31
Expected recruitment end date
2020-09-21, 1399/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy of Letrozole on the duration and severity of Ovarian hyperstimulation syndrome
Public title
Evaluation of efficacy of Letrozole on the duration and severity of Ovarian hyperstimulation syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having Ovarian hyperstimulation syndrome
Exclusion criteria:
Lack of incidence of hyperstimulation syndrome after receiving ovarian stimulant drug due to infertility
Patient dissatisfaction to participate in the study
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random number table: Each person in the community is assigned a two-digit code and then randomly 20 numbers of two-digit number range selected from the random number table and based on the selected code, the case group is determined and similarly choose
the control group.
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
Ethics committee of kerman University of Medical Sciences
Street address
No 6 Hezaroyekshab Ave
City
Kerman
Province
Kerman
Postal code
7618614937
Approval date
2020-09-19, 1399/06/29
Ethics committee reference number
IR.KMU.AH.REC.1399.083
Health conditions studied
1
Description of health condition studied
Ovarian hyperstimulation syndrome
ICD-10 code
N98.1
ICD-10 code description
Hyperstimulation of ovaries
Primary outcomes
1
Description
Duration of Ovarian hyperstimulation syndrome
Timepoint
2-3 weeks after intervention
Method of measurement
laboratory tests
Secondary outcomes
1
Description
Liver enzymes
Timepoint
2 weeks after intervention
Method of measurement
laboratory tests
2
Description
Hematocrit
Timepoint
2 weeks after intervention
Method of measurement
laboratory tests
3
Description
Ratio of urea to creatinine
Timepoint
2 weeks after intervention
Method of measurement
laboratory tests
4
Description
Evacuation of ascites
Timepoint
7 & 14 days after intervention
Method of measurement
Number of ascites Evacuations
5
Description
Existence of thrombosis
Timepoint
7 & 14 days after intervention
Method of measurement
Ultrasound
6
Description
Ovary size
Timepoint
2 weeks after intervention
Method of measurement
Ultrasound
7
Description
Shortness of breath
Timepoint
7 & 14 days after intervention
Method of measurement
history
Intervention groups
1
Description
Intervention group: Prescription of Letrozole tablet 2.5 mg from Abu Reihan company with chemical formula C17H11N5 1 orally daily for 10 days along with routine treatment of ovarian hyperstimulation syndrome and evaluation of drug effect by testing and sonography within 3 weeks Since the start of letrozole
Category
Treatment - Drugs
2
Description
Control group: Evaluation of tests and sonograghy of the control group based on the case that they have received only routine treatment of ovarian hyperstimulation syndrome.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipoor Hospital
Full name of responsible person
Victoria Habibzadeh
Street address
Afzalipoor Hospital, Zendan Square
City
Kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Phone
+98 34 3223 5011
Email
v_habibzadeh@kmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Hassani
Street address
Tahmasbabad Square, Ebnesina Street
City
Kerman
Province
Kerman
Postal code
7619813159
Phone
+98 34 3226 3719
Email
info.knrc@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
100
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
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Afzalipoor Hospital, Zendan Square
City
Kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Phone
+98 34 3223 5011
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
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Afzalipoor Hospital, Zendan Square
City
Kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Phone
+98 34 3223 5011
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
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Afzalipoor Hospital, Zendan Square
City
Kerman
Province
Kerman
Postal code
۷۶۱۶۹۱۳۹۱۱
Phone
+98 34 3223 5011
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available