An interventional study that is designed to assess the effect of endometrial incision in the fundus of the uterine on the success rate of IVF in infertile women with a history of implantation failure.
Design
Phase 3 clinical trial with a control group, parallel design, using the random allocation rule is performed on 264 patients.
Settings and conduct
This randomized study will be performed on 264 patients with IVF indication in Yas Hospital with a convenient sampling method.
Participants/Inclusion and exclusion criteria
Inclusion criteria include infertile women candidates for IVF with a history of implantation failure aged 20 to 42 years, with a body mass index of less than 30 kg/m2, and having 3 grade A or B fetuses. Criteria for not entering: Presence of uterine anomaly, submucosal leiomyoma, and endometriosis polyp.
Intervention groups
The intervention group undergoes hysteroscopy on one of the days 18-24 of the cycle before embryo transfer, and a small incision is made in the uterine fundus with hysteroscopic scissors, while no intervention is done for the control group. All participants are advised to refer on days 2 to 3 of the cycle. Then, on the second or third day of the menstrual cycle, 6 mg oral estradiol ( Abu Reihan Pharmaceutical Company) is prescribed daily. Simultaneously, the initial evaluation of vaginal ultrasound is performed to examine the ovaries and the endometrium thickness. after 4 days, the ultrasound will be repeated and the dose of the drug will be adjusted. In serial vaginal ultrasound, after the endometrial thickness reaches 8 mm, 100 mg progesterone (Iran Hormone Pharmaceutical Company) is prescribed daily, on the 4th day of progesterone initiation, two or three grade A or B embryos will be transferred under an ultrasound guide with a COOk catheter.
Main outcome variables
Biochemical pregnancy, and clinical pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091012002576N21
Registration date:2021-08-22, 1400/05/31
Registration timing:prospective
Last update:2021-08-22, 1400/05/31
Update count:1
Registration date
2021-08-22, 1400/05/31
Registrant information
Name
Fatemeh Davari Tanha
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8831 3955
Email address
fdavaritanha@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of endometrial incision in the fundus of uterine on the success rate of IVF in infertile women with a history of implantation failure
Public title
The effect of endometrial incision in the fundus of uterine on the success rate of assisted reproductive technique
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Body mass index lower than 30
Having at least 3 grade A or B fetuses
Exclusion criteria:
Uterine anomaly
Sub mucosal leiomyoma
Endometriosis polyp
Age
From 20 years old to 42 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
264
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation rule: First, 132 letters A and 132 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 (endometrial incision) or B (control group) are determined by a lot.
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 Tehran University of Medical Sciences
Street address
Tehran 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
2021-08-17, 1400/05/26
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.556
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
Biochemical pregnancy
Timepoint
Once, 14 days after fetus transfer
Method of measurement
Blood sampling
2
Description
Clinical pregnancy
Timepoint
Once, 6 to 8 weeks after fetus transfer
Method of measurement
Pregnancy sac observation in transvaginal ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients undergo hysteroscopy on one of the days 18-24 of the cycle before embryo transfer, and a small incision is made in the uterine fundus with hysteroscopic scissors. To start the transition cycle, all participants are advised to refer on days 2 to 3 of the cycle. Then, on the second or third day of the menstrual cycle, 6 mg oral estradiol ( Abu Reihan Pharmaceutical Company) is prescribed daily. Simultaneously, the initial evaluation of vaginal ultrasound is performed to examine the ovaries and the endometrium thickness. after 4 days, the ultrasound will be repeated and the dose of the drug will be adjusted. In serial vaginal ultrasound, after the endometrial thickness reaches 8 mm, 100 mg progesterone (Iran Hormone Pharmaceutical Company) is prescribed daily, on the 4th day of progesterone initiation, two or three grade A or B embryos will be transferred under an ultrasound guide with a COOk catheter.
Category
Treatment - Surgery
2
Description
Control group: To start the transition cycle, all participants are advised to refer on days 2 to 3 of the cycle. Then, on the second or third day of the menstrual cycle, 6 mg oral estradiol ( Abu Reihan Pharmaceutical Company) is prescribed daily. Simultaneously, the initial evaluation of vaginal ultrasound is performed to examine the ovaries and the endometrium thickness. after 4 days, the ultrasound will be repeated and the dose of the drug will be adjusted. In serial vaginal ultrasound, after the endometrial thickness reaches 8 mm, 100 mg progesterone (Iran Hormone Pharmaceutical Company) is prescribed daily, on the 4th day of progesterone initiation, two or three grade A or B embryos will be transferred under an ultrasound guide with a COOk catheter.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas hospital
Full name of responsible person
Fatemeh Davari Tanha
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
fdavaritanha@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice-Dean of Research of Tehran University of Medical Sciences, Dr. Sahraiyan
Street address
Vice-Dean of Research, Tehran University of Medical Sciences, Floor 6, Qods St., Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416634793
Phone
+98 21 8163 3689
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?