Comparison of the effect of granulocyte colony-stimulating factor (G-CSF) injection in the sub endometrium on the success rate of frozen embryo transfer cycle in women with repeated implantation failure
Comparison the effect of granulocyte colony stimulating factor (G-CSF) injection in the subendometrium on the success rate of frozen embryo transfer cycle in women with repeated implantation failure
Design
This three-phase clinical trial, with parallel groups, randomized (using the allocation randomization rule) is performed on 100 infertile women.
Settings and conduct
This clinical trial study will be conducted in the infertility department of Yas Hospital Complex, on infertile women diagnosed with repeated implantation failure.
Participants/Inclusion and exclusion criteria
Inclusion criteria: infertile women aged 20 to 40 diagnosed with recurrent implantation failure, and having good quality embryos (grade A or B).
Intervention groups
For all patients, hysteroscopy and endometrial scraping are performed in the luteal phase of the cycle before embryo transfer. In the intervention group, During hysteroscopy, 300 micrograms of G-CSF is injected into four sub-endometrial regions of the uterus (anterior, posterior, and two laterals) using a puncture needle, then with the hysteroscope grasper, scratches are made in four other points of the uterus.
Main outcome variables
Ongoing pregnancy rate and live birth rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150105020558N7
Registration date:2024-05-31, 1403/03/11
Registration timing:prospective
Last update:2024-05-31, 1403/03/11
Update count:0
Registration date
2024-05-31, 1403/03/11
Registrant information
Name
Mahbod Ebrahimi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8882 7794
Email address
maebrahimi@tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2025-08-22, 1404/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of granulocyte colony-stimulating factor (G-CSF) injection in the sub endometrium on the success rate of frozen embryo transfer cycle in women with repeated implantation failure
Public title
Comparison the effect of granulocyte colony stimulating factor (G-CSF) on the success rate of frozen embryo transfer cycle
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
infertile women with repeated implantation failure
with good quality embryo (Grade A or B)
Exclusion criteria:
Patients with husband having azoospermia
Patients with uterine malformations, endometrial polyps, submucosal fibroids, or intrauterine adhesions
History of surgery on the uterus due to acquired or congenital uterine abnormalities
Patients with severe endometriosis (stage 3, 4)
Age
From 20 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation rule: 50 small envelopes containing the letter A and 50 small envelopes in the same shape containing the letter B exist in a bag, and one envelope is selected randomly for each patient.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the doctor who evaluates the outcomes does not know the participants' treatment group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Tehran University of Medical Sciences
Street address
Ethics committee of Tehran University of Medical Sciences, School of Medicine, Pour Sina Ave., Qods Blvd.
City
Tehran
Province
Tehran
Postal code
1598718311
Approval date
2024-05-21, 1403/03/01
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.067
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Live birth
Timepoint
Once, after pregnancy termination
Method of measurement
Questioning
2
Description
Ongoing pregnancy
Timepoint
Once, after the 20th week of pregnancy
Method of measurement
Ultrasound of the fetus
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the luteal phase of the cycle before embryo transferring, hysteroscopy is performed. During hysteroscopy, 300 micrograms of G-CSF is injected into four sub-endometrial regions of the uterus (anterior, posterior, and two laterals) using a puncture needle, then with the hysteroscope grasper, scratches are made in four other points of the uterus. The embryo is transferred in the next cycle.
Category
Treatment - Drugs
2
Description
Control group: In the luteal phase of the cycle before embryo transferring, hysteroscopy is performed. During hysteroscopy, with the hysteroscope grasper, scratches are made in four points of the uterus. the embryo is transferred in the next cycle.
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
No - There is not 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
No - There is not 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 the manuscript is published.
To whom data/document is available
No limitations.
Under which criteria data/document could be used
Those who are allowed to request to receive non-identifiable personal data or other documents must have a written proposal (including the type of statistical analysis) and the ethics number. any additional analysis must be performed under the corresponding author's supervision.
From where data/document is obtainable
Communicate with the corresponding author via email: maeb214@yahoo.com
What processes are involved for a request to access data/document
Any request must be sent through e-mail and accompanied by a proposal with an ethics code under the supervision of Dr. Ebrahimi.