Evaluating the effects of local endometrial injury on the
success rate of pregnancy in patents under invitro fertilization (IVF).
Design
Interventional clinical trial , sample size 324. Selection by list of clients and the availability and availability of entry conditions
Settings and conduct
A study on infertile women with at least one history of unsuccessful IVF referred to the Reproductive Clinic of Mahdieh Hospital in Tehran, whose endometrial thickness will be inappropriate. Patients will normally undergo IVF and ovulation and in vitro fertilization. Initial ultrasound will be performed before the intervention in the luteal phase. On the first to third day of the cycle, small scratches are made in different parts of the uterus using a pipette. On day 8-10 of the cycle, an ultrasound will be performed again. If thickness of more than 7 mm, while starting progesterone as a cyclogest suppository, the patient is introduced for embryo transfer to be done in two or three days. Β-hCG titers were also checked 2 weeks after embryo transfer. Also, 5 weeks after the transfer, the presence of clinical pregnancy will be examined.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age 18-40; Normal uterine cavity; Lack of OCP or GnRH reagent for FET ; abnormal endometrial wall diameter.
Exclusion criteria: Intrauterine factors including fibroids; Endometrial and endometrial hyperplasia; Active vaginal and cervical infection; systemic disease
Intervention groups
intervention group:women referring to the infertility clinic, IVF candidates who have inappropriate endometrial thickness, who received the intervention of endometrial damage with papillae.
control group:patients themselves before the intervention
Main outcome variables
Effect of endometrial abrasion on endometrial condition, β-hCG positivity ,and the presence of clinical pregnancy with ultrasound.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140224016705N11
Registration date:2021-11-05, 1400/08/14
Registration timing:registered_while_recruiting
Last update:2021-11-05, 1400/08/14
Update count:0
Registration date
2021-11-05, 1400/08/14
Registrant information
Name
zahra heidar
Name of organization / entity
sbmu
Country
Iran (Islamic Republic of)
Phone
+98 21 4461 2416
Email address
dr_zheidar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effects of local endometrial injury on success of pregnancy rate in patients candidate for in vitro fertilization (IVF).
Public title
Evaluating the effects of local endometrial injury on success of pregnancy rate in patients candidate for in vitro fertilization.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of infertility with a history of unsuccessful IVF
candidate for in vitro fertilization
Existence of inappropriate endometrial thickness based on ultrasound
Age 40 years or less
Do not use OCP or GnRH for FET in the previous cycle
Appropriate quality of embryos for transfer
Exclusion criteria:
Vaginal or cervical active infection
Endometrial Hyperplasia
Existence of endometritis
Presence of known intrauterine pathologies on ultrasound or hysteroscopy such as fibroids or myomas
Asherman syndrome
Uterine anomaly
Age
From 18 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
324
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti university of medical sciences, Arabi Ave, Yamen St, Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2021-01-31, 1399/11/12
Ethics committee reference number
ir.sbmu.msp.rec.1399.650
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Existence of clinical pregnancy (formation of pregnancy sac and fetal heart) in IVF patient under the intervention of endometrial abrasion with papillae.
Timepoint
5 weeks after the transfer, transvaginal ultrasound will examine the presence of clinical pregnancy (formation of pregnancy sac and fetal heart).
Method of measurement
transvaginal ultrasound
2
Description
β-hCG positivity (greater than 10 mIU / mL)
Timepoint
Β-hCG titer was checked 2 weeks after embryo transfer
Method of measurement
Using a laboratory-approved β-hCG test
3
Description
The effect of endometrial abrasion on endometrial condition
Timepoint
On day 8-10 of the cycle, an ultrasound will be performed again and the condition of the endometrium will be examined
Method of measurement
transvaginal ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Includes infertile women with at least one failed IVF history and re-candidate for IVF referred to the Reproductive Clinic of Mahdieh Hospital in Tehran, whose endometrial thickness is based on inappropriate ultrasound criteria (echogenic or thin view with a thickness of less than 5 mm) and in ultrasound or hysteroscopy of internal pathology They will not have a uterus such as a myoma or fibroid. Patients are routinely involved in the IVF process and ovulation and in vitro fertilization will be performed for each patient. The initial ultrasound will be done before the intervention in the luteal phase (about a week before the next period). Then, on the first to third day of the cycle, small blows were applied to different parts of the uterus using a pipette and small scratches were created. On day 8-10 of the cycle, ultrasound was performed again and the condition of the endometrium was examined. If there is a triple line view or a thickness of more than 7 mm, while starting progesterone as a cyclogest suppository, the patient is introduced for embryo transfer to be done in two or three days. Β-hCG titers were also checked 2 weeks after embryo transfer. Also, 5 weeks after the transfer, the presence of clinical pregnancy (formation of pregnancy sac and fetal heart) will be examined by transvaginal ultrasound. Outcomes studied include the effect of endometrial abrasion on endometrial condition adaptation, β-hCG positivity (greater than 10 mIU / mL) and the presence of clinical pregnancy with ultrasound.
Category
Treatment - Devices
2
Description
Control group: Each patient is considered as a control group. In this way, each patient is classified as a control group according to the infertility conditions in terms of uterine endometrial diameter before the intervention. Conditions before and after endometrial ablation with papillae in terms of uterine diameter and fertility will be evaluated as case and control groups.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdieh Hospital Infertility Center
Full name of responsible person
Dr Zahra Heydar
Street address
Shahrzad St
City
tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 5506 2628
Email
Z.heydar@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
zahra Heidar
Street address
Mahdieh Hospital, Shoosh Square
City
tehran
Province
Tehran
Postal code
1185817311
Phone
+98 21 8524 5659
Fax
+98 21 8524 5659
Email
dr_zheaidar@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?