This study is an interventional study that is designed to compare the effect of combining letrozole and gonadotropin and gonadotropin alone on the success rate of assisted reproductive techniques.
Design
This phase 3 clinical trial with a control group, with parallel groups, double-blind, randomized using the Random allocation rule is performed on 82 patients.
Settings and conduct
This randomized clinical trial study is performed on 82 patients who are candidates for IVF in Yas Hospital, 2021. The sampling method is convenient. This study is performed as a double-blind study, the patient and analyzer do not know the type of treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria include Women with pelvic endometriosisher in her first IVF cycle,with 18 to 35 year-old and body mass index lower than 30 kg/m2, without any uterine diseases and Anti-mullerin hormone greater than 1 ng/ml.
Pelvic endometriosis was detected in transvaginal ultrasound
Criteria for not entering: women who underwent letrozole or clomiphene therapy for induction ovulation, Sever endometriosis with DIE, Submucosal myoma with any size and intramural myoma greater than 3 cm was detected in transvaginal ultrasound, Withdraw to participation
Intervention groups
From the third day of menstruation, after vaginal ultrasound and examination of the number of follicles in both ovaries, in the intervention group gonadotropin with letrozole ( 5 mg daily for up to 5 days) begin. When the follicle diameters reach 10 to 12 mm, HMG is added to the cycle and continues with gonadotropin until the trigger day. The same thing is done in the control group and the only placebo is used instead of letrozole tablets.
Main outcome variables
Biochemical pregnancy rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120104008611N12
Registration date:2021-03-19, 1399/12/29
Registration timing:prospective
Last update:2021-03-19, 1399/12/29
Update count:1
Registration date
2021-03-19, 1399/12/29
Registrant information
Name
Hamideh Pakniat
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 282242452
Email address
hpakniat@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-06-05, 1400/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of combining letrozole and gonadotropin with gonadotropin alone on the IVF / ICSI cycle success rate in women with endometriosis
Public title
Assessment the effect of combining letrozole and gonadotropin on the IVF / ICSI cycle success rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with 18 to 35 year-old
Body mass index lower than 30 kg/m2
In her first IVF cycle
Without any uterine diseases
Sperm motility of at least 20%in sperm analysis
Anti-mullerin hormone greater than 1 ng/ml
Pelvic endometriosis was detected in transvaginal ultrasound
Exclusion criteria:
Women who underwent letrozole or clomiphene therapy for induction ovulation
Sever endometriosis with DIE
Submucosal myoma with any size and intramural myoma greater than 3 cm was detected in transvaginal ultrasound
Withdraw to participation
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
82
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation rule: First, 41 letters A and 41 letters B are written on special papers that are not marked inside. Then all of them are placed in a bag and for each patient, after obtaining informed consent, a paper is removed randomly and without replacement, and based on the letter written on it, the desired intervention is performed for the patient. In addition, interventions A (letrozole) or B (clomiphene) are determined by a lot.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is performed double-blind, the participants, and the analyzer do not know the type of treatment. The participants, because of placebo usage, do not know the type of their treatment. Also, the analyzer does not know about the treatment group codes in the SPSS datasheet.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
ehran University of Medical Sciences,School of Medicine, Tehran Province, Tehran, Pour Sina St" to "Tehran University of Medical Sciences,School of Medicine, Tehran Province, Tehran, Pour Sina St
City
Tehran
Province
Tehran
Postal code
1598718311
Approval date
2021-01-23, 1399/11/04
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1399.100
Health conditions studied
1
Description of health condition studied
Endometriosis
ICD-10 code
N80.9
ICD-10 code description
Endometriosis, unspecified
Primary outcomes
1
Description
Biochemical pregnancy
Timepoint
Once, 14 days after fetus transfer
Method of measurement
Blood sampling
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: From the third day of menstruation, after vaginal ultrasound and examination of the number of follicles in both ovaries, in the intervention group gonadotropin with letrozole ( 5 mg daily for up to 5 days) begin. When the follicle diameters reach 10 to 12 mm, HMG is added to the cycle and continues with gonadotropin until the trigger day.
Category
Treatment - Drugs
2
Description
Control group: From the third day of menstruation, after vaginal ultrasound and examination of the number of follicles in both ovaries, in the control group gonadotropin with placebo begin. When the follicle diameters reach 10 to 12 mm, HMG is added to the cycle and continues with gonadotropin until the trigger day.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas hospital
Full name of responsible person
Hamideh Pakniat
Street address
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8608 9089
Email
pakniat110@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamideh Pakniat
Street address
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8608 9089
Email
pakniat110@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Hamideh Pakniat
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8608 9089
Email
pakniat110@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamideh Pakniat
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8608 9089
Email
pakniat110@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hamideh Pakniat
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Yas hospital, Next to the sarv street , North Nejatollahi street , karim khan ave
City
Tehran
Province
Tehran
Postal code
1597856511
Phone
+98 21 8608 9089
Email
pakniat110@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified participants
When the data will become available and for how long
After manuscript published
To whom data/document is available
No limitations
Under which criteria data/document could be used
The data is only available to the project manager, Dr. Pakniat, and any analysis must be done with her opinion.
From where data/document is obtainable
Dr. Pakniat
What processes are involved for a request to access data/document
Any request must be made in writing and accompanied by a proposal with an ethics code under the supervision of Dr. Pakniat.