Evaluation of the effect of letrozole in the prevention of ovarian hyperstimulation syndrome in patients at risk of treatment with ovulation-stimulating drugs
Determination of the effect of letrozole in the prevention of ovarian hyperstimulation syndrome in treatment with ovulation-stimulating drugs
Design
Randomised, superiority, parallel group trial. Randomisation was centralised and computerised with excel software rand function.
Settings and conduct
The study was performed at the Infertility Center of Isfahan University of Medical Sciences. Diagnosis of polycystic ovaries was made according to Rotterdam criteria, including two of the three items of hyperandrogenism disorder, chronic anovulation and polycystic ovary appearance in morphological examination with transvaginal ultrasound (TVS).
Lab tests including FSH, LH, progesterone, estradiol (E2) and Anti-Müllerian hormone were performed.
Ultrasound assessment was performed to measure the number of ovarian follicles with a size of 2 -10 mm and evaluation the thickness of the uterine endometrium on 3th day of the menstrual cycle.
Then the GNRH Antagonist treatment protocol was performed for patients in both case and control groups.
Participants/Inclusion and exclusion criteria
Patients with polycystic ovaries and fertility disorders
Intervention groups
Intervention group: Five daily doses of recombinant follicle-stimulating hormone 150 Unit/day with Manogan drug 75 Unit/day with Letrozole 5 mg/daily.
Control group: Five daily doses of recombinant follicle-stimulating hormone 150 Unit/day with Manogan drug 75 Unit/day.
Main outcome variables
Reduced occurrence of ovarian hyperstimulation syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180313039085N1
Registration date:2021-04-10, 1400/01/21
Registration timing:retrospective
Last update:2021-04-10, 1400/01/21
Update count:1
Registration date
2021-04-10, 1400/01/21
Registrant information
Name
Tayeb Ramim
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6683 0007
Email address
tramim@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2021-03-21, 1400/01/01
Actual recruitment start date
2020-03-20, 1399/01/01
Actual recruitment end date
2021-03-21, 1400/01/01
Trial completion date
2021-03-21, 1400/01/01
Scientific title
Evaluation of the effect of letrozole in the prevention of ovarian hyperstimulation syndrome in patients at risk of treatment with ovulation-stimulating drugs
Public title
Evaluation of the effect of letrozole in the prevention of ovarian hyperstimulation syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for treatment with ovarian superovulation drugs
history of one year of infertility at least
Body mass index less than 25 kg/m2
Antimullerian hormone levels higher than 5 ng/ml
Exclusion criteria:
History of any hormone therapy during the previous three months
History of allergy to letrozole and other aromatase inhibitors
History of heart disease
History of kidney disease
History of liver disease
History of endocrine diseases
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling was non-probabilistic and easy. Then patients were randomly divided into four groups: 40 in the letrozole treatment group and 40 in the letrozole-free group. In this randomization method, quadruple therapy blocks (with 10 probabilities) were randomly moved back and forth, and a balanced random list of two treatment groups was obtained with the aim that if the total number of samples was not complete, both groups would be equal.
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 Isfahan University of Medical Sciences
Street address
Hezar Jerib street, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-02-09, 1399/11/21
Ethics committee reference number
IR.MUI.MED.REC.1399.1031
Health conditions studied
1
Description of health condition studied
Ovarian Irritation Syndrome
ICD-10 code
N98.1
ICD-10 code description
Infection associated with artificial insemination
2
Description of health condition studied
Hyperstimulation of ovaries
ICD-10 code
N98.1
ICD-10 code description
Hyperstimulation of ovaries
Primary outcomes
1
Description
Hyperstimulation of ovaries
Timepoint
Two weeks after starting treatment
Method of measurement
Mild, Moderate, Severe
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Five daily doses of recombinant follicle-stimulating hormone 150 Unit/day with Manogan drug 75 Unit/day with Letrozole 5 mg/daily.
Category
Treatment - Drugs
2
Description
Control group: Five daily doses of recombinant follicle-stimulating hormone 150 Unit/day with Manogan drug 75 Unit/day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Center of Isfahan University of Medical Sciences
Full name of responsible person
Keihaneh Asasi
Street address
Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
tayebramim@yahoo.com
Web page address
https://mui.ac.ir/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Keihaneh Asasi
Street address
Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
tayebramim@yahoo.com
Web page address
https://mui.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Keihaneh Asasi
Position
fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
tayebramim@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Keihaneh Asasi
Position
fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
tayebramim@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Keihaneh Asasi
Position
fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Isfahan University of Medical Sciences, Hezar Jerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
tayebramim@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Confidentiality of patient data
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