Evaluation of the efficacy of letrozole in the luteal phase compared to sterolix acetate in the prevention of premature ovarian hyperstimulation syndrome (OHSS): a single blind randomized clinical trial
Determination and comparison of letrozole in the luteal phase with cetrolix acetate for the prevention of premature OHSS
Design
A randomized, single blind, comparative trial on the two groups, 55 people in each group, a total of 110 patients, randomization with non-transparent sealed envelopes with random sequence.
Settings and conduct
The place of the study will be the infertility department of Akbarabadi Hospital in Tehran; the population of the study is patients who are in the cycle of IVF and are going towards hyperstimulation ovarian syndrome; the blinding is single type in which the doctor evaluating the outcome of the study does not know the type of drug used.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 20 to 35 years; BMI 18 to 29 kg/m2; AMH level more than 4 nanograms/ml; The number of antral follicles (AFC) in each ovary is more than 12, as confirmed by transvaginal ultrasound; The number of punctured follicles is more than 15 per ovary (follicle diameter 14mm per day of recovery egg).
Exclusion criteria: Contraindications for use of letrozole or sterolix acetate, including severe liver and kidney dysfunction; Women with estradiol (E2) level less than 4000 pg/ml per trigger day.
Intervention groups
Intervention group1: Tab Letrozole 2.5 mg daily for 7 days.
Intervention group2: Amp cetrolix acetate 0.25 mg subcutaneous up to 7 days.
Main outcome variables
Ovarian hyperstimulation syndrome
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240627062268N1
Registration date:2024-08-25, 1403/06/04
Registration timing:prospective
Last update:2024-08-25, 1403/06/04
Update count:0
Registration date
2024-08-25, 1403/06/04
Registrant information
Name
Mina Ghorbani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6636 0381
Email address
dr.mina71@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of letrozole in the luteal phase compared to sterolix acetate in the prevention of premature ovarian hyperstimulation syndrome (OHSS): a single blind randomized clinical trial
Public title
Comparison of letrozole and Cetrolix acetate in the prevention of ovarian hyperstimulation syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 20 to 35 years old
BMI 18 to 29 kg/m2
AMH level more than 4ng/ml
The number of antral follicles (AFC) in each ovary more than 12, confirmed by transvaginal ultrasound
Serum level of estradiol (E2) more than 4000 pg/ml on the trigger day
The number of punctured follicles more than 15 per ovary (follicular diameter of 14 mm on the day of egg retrieval)
Exclusion criteria:
Contraindications for use of letrozole or cetrolix acetate include severe liver and kidney dysfunction
Women with estradiol (E2) level less than 4000 pg/ml in trigger day
Age
From 20 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by blocked randomization method. Blocks of four will be used for each of the treatment regimens. In this way, a person other than the doctor who evaluates the outcome, determines the treatment block with the help of a table of random numbers. In this method, the number of blocks is equal. Blocks of four include: TCCT.TCTC.TTCC.CTCT.CTTC.CCTT.
C refers to the intervention of letrozole, and T refers to the intervention of Sterolix Acetate. A random numbers table will be used to select each block, and then the allocation determines based on each block sequence.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the single blinding in this study, we blind the doctor evaluating the outcome. In this way, the doctor who follows up the patient does not know the type of treatment received by the patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Science
Street address
No 83 ,Alborz 8 ,Shahid Shahparian Town , Shahid Babaei highway, Tehran
City
Tehran
Province
Tehran
Postal code
1651154348
Approval date
2024-06-24, 1403/04/04
Ethics committee reference number
IR.IUMS.FMD.REC.1403.188
Health conditions studied
1
Description of health condition studied
Ovarian Hyperstimulation Syndrom
ICD-10 code
N98.1
ICD-10 code description
Hyperstimulation of ovaries
Primary outcomes
1
Description
Ovarian Hyperstimulation Syndrom (OHSS)
Timepoint
As soon as the first clinical symptoms appear, the third day and the seventh day after trigger injection
Method of measurement
Clinical signs
2
Description
Serum Hematocrit level
Timepoint
On the day of trigger injection, and then on the third and seventh day after trigger injection
Method of measurement
CBC lab test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Letrozole tablet 2.5 mg daily from the day of egg retrieval for 7 days
Category
Prevention
2
Description
Intervention group 2:Cetrolix acetate 0.25 mg subcutaneous ampoule from the day of egg retrieval for 7 days
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Akbar Abadi Hospital
Full name of responsible person
Dr.Farahnaz Farzaneh
Street address
Bagh-ferdus Station, Molavi Street
City
Tehran
Province
Tehran
Postal code
1168743514
Phone
+98 21 5560 6034
Email
akbarabadihosp@yahoo.com
Web page address
https://crta.iums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Kazem Mousavizadeh
Street address
Iran University of Medical Sciences, next to Milad Tower, Hemat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 4837
Email
mousavik@gmail.com
Web page address
https://oldfatim.iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?