Determination of the effect of letrozole addition to GnRH-antagonist protocol on IVF/ICSI cycle outcome in women with endometriosis
Design
This study is a double-blinded parallel clinical trial
Settings and conduct
This study will be conducted on women aged 18-42 years with endometriosis-related infertility candidate for IVF/ICSI referring to the infertility clinic of Arash Women's Hospital after receiving written consent. The eligible individuals will be randomized into one of the following two groups: 1-intervention group: daily gonadotropins from cycle day 2 and co-treatment with letrozole 2.5 mg twice a day from day 3 until 5 days. GnRH antagonist (Cetrotide 0.25 mg or ganirelix 0.25 mg) will be started when the size of the largest follicle reaches 14 mm. 2-Control group: adding placebo to the antagonist protocol. Follicular growth will be monitored every three days by transvaginal sonography. When at least two follicles with a size of 17 mm were observed, 10,000 units of HCG will be injected for triggering and ultimate maturation of the oocyte. the ovarian puncture will be performed 34-36 hours after hCG injection.
Participants/Inclusion and exclusion criteria
In this study, women aged 18-42 with a normal BMI undergoing ICSI-IVF because of endometriosis induced infertility will be included in the study and women with male factor infertility, decreased ovarian reserve, repeated IVF failure, Medical diseases, congenital anomalies of the uterus and candidate for donation will be excluded.
Intervention groups
Adding letrozole to the antagonist cycle in the intervention group and adding placebo to the cycle in the control group
Main outcome variables
Endometrial pattern and thickness, MII oocyte, embryo quality, chemical pregnancy rate, clinical pregnancy rate, implantation rate and ongoing pregnancy rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150310021420N4
Registration date:2018-07-13, 1397/04/22
Registration timing:registered_while_recruiting
Last update:2018-07-13, 1397/04/22
Update count:0
Registration date
2018-07-13, 1397/04/22
Registrant information
Name
Maryam Farid Mojtahedi
Name of organization / entity
Arash women hospital,clinic for infertility,Tehran university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 8755
Email address
m_fmojtahedi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of letrozole addition to GnRH-antagonist protocol on IVF/ICSI cycle outcome in women with endometriosis
Public title
The effect of letrozole on treatment of endometriosis-related infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
consent to participation
aged between 18 to 42 years
BMI ranged between 18.5 to 24.9
endometriosis-induced infertility and ICSI-IVF candidate
Endometriosis diagnosed by pathology reports
Exclusion criteria:
Sever Male Factor
Evidence of reduced ovarian reserve (FSH levels above 10, AMH levels lower than 1, AFC reduction)
Endocrine disorders (diabetes - Thyroid diseases - Hyperprolactinemia - Hypothalamic amenorrhea and ...)
Known case of medical and immunologic diseases (lupus, rheumatoid arthritis, antiphospholipid syndrome, cardiovascular, liver and kidney disease)
Congenital anomalies of the uterus and endometrial cavity problems (bicorn or Unicorn uterus, Asherman syndrome, myoma, polyps, etc.)
Candidate for donation (egg donation and surrogacy)
Recurrent IVF failures (more than three consecutive failures)
Age
From 18 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
144
Randomization (investigator's opinion)
Randomized
Randomization description
According to Stratified Block randomization, the samples will be divided into two groups of intervention and control (based on the PCOS variable), the number of blocks will be 6. The random allocation list is solely available to the epidemiologist. For Concealment of the random allocation process, treatments will be written on 144 cards, respectively. then the cards are placed inside sealed envelopes. When the physician announces the eligibility of a patient, the methodologist will provide the physician with the envelope.
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 School of Medicine - Tehran University of Medical Sciences
Street address
Poorsina st - Qods st - enghelab st - Tehran-Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-05-15, 1397/02/25
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1397.075
Health conditions studied
1
Description of health condition studied
endometriosis-related infertility
ICD-10 code
N97.8
ICD-10 code description
Female infertility of other origin
Primary outcomes
1
Description
Endometrial Line Thickness (EL)
Timepoint
Triggering day
Method of measurement
Trans vaginal sonography (TVS)
2
Description
M II oocytes
Timepoint
after oocyte retrieval
Method of measurement
Questionnaire
3
Description
Embryo Quality
Timepoint
after ICSI
Method of measurement
Report sheet of Embryology ward
4
Description
Chemical Pregnancy
Timepoint
2 weeks after ET
Method of measurement
BHCG Test
5
Description
Clinical pregnancy
Timepoint
Presence of pregnancy sac in ultrasound 5 weeks after ET
Method of measurement
Trans vaginal sonography (TVS)
Secondary outcomes
1
Description
Ongoing pregnancy
Timepoint
Ongoing pregnancy until 12 weeks of gestation
Method of measurement
sonography
Intervention groups
1
Description
Intervention group: Adding letrozole at a dose of 2.5 mg per day from the third day of the cycle to the antagonist treatment cycle for 5 days.
Category
Treatment - Drugs
2
Description
Control group: Antagonist protocol without placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash women's hospital
Full name of responsible person
Dr Maryam Farid-Mojtahedi
Street address
No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Email
m_fmojtahedi@ssu.ac.ir
Web page address
http://arash.tums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Ali Sahraian
Street address
Qods St, Keshavarz Blv, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3619
Fax
+98 21 8163 3611
Email
rmo@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
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
Maryam Farid-Mojtahedi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Fax
Email
m_fmojtahedi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Maryam Farid-Mojtahedi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Email
m_fmojtahedi@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Maryam Farid-Mojtahedi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
No. 162 َAlley (Abdul Majid), Shahid Baghdarnia Street (North Rashid), Shahid Bagheri Highway, Resalat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Email
m_fmojtahedi@tums.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