Comparison of the effect of sequential embryo transfer (at the stage of cleavage and blastocyst) with embryo transfer only at the blastocyct stage on pregnancy rate in patients with recurrent implantation failure
Comparison of the effect of sequential embryo transfer (in the cleavage and blastocyst stage) with embryo transfer only in the blastocyst stage on the frequency of pregnancy in patients with recurrent implant failure
Design
A clinical trial with a control group was performed on 200 women with a history of recurrent implantation failure with parallel groups, double-blind, randomized, phase 2. Excel software rand function was used for randomization.
Settings and conduct
Women with a history of recurrent implant failure, the first to third day of menstruation under ultrasound and in the absence of follicles above 10 mm and appropriate endometrial thickness, endometrial preparation with estradiol 6 mg daily after receiving estradiol for 9-10 days The patient will have a tvs ultrasound and will add a 400 bd progesterone suppository if the thickness is> 7 mm. In the two-stage embryo transfer group, one embryo is transferred in the cleavage stage on the third day and then on the 5th day, one embryo is transferred in the blastocyst stage. In the control group, both embryos are transferred in the clearance stage on the third day.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age less than 45 years, having at least two good three-day-old embryos, women with a history of recurrent implant failure
Exclusion criteria: having any uterine abnormalities.
Intervention groups
In the two-stage embryo transfer group, one embryo is transferred in the cleavage stage on the third day and then on the 5th day, one embryo is transferred in the blastocyst stage. All embryos are transferred under ultrasound guidance using a soft catheter.
In the control group, both embryos are transferred in the clearance stage on the third day. All embryos are transferred under ultrasound guidance using a soft catheter.
Main outcome variables
pregnancy rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160722029027N10
Registration date:2022-03-14, 1400/12/23
Registration timing:retrospective
Last update:2022-03-14, 1400/12/23
Update count:0
Registration date
2022-03-14, 1400/12/23
Registrant information
Name
Leila Nazari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8000
Email address
nazari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-21, 1399/09/01
Expected recruitment end date
2021-11-27, 1400/09/06
Actual recruitment start date
2020-12-26, 1399/10/06
Actual recruitment end date
2021-11-29, 1400/09/08
Trial completion date
2021-11-30, 1400/09/09
Scientific title
Comparison of the effect of sequential embryo transfer (at the stage of cleavage and blastocyst) with embryo transfer only at the blastocyct stage on pregnancy rate in patients with recurrent implantation failure
Public title
the effect of sequential embryo transfer on pregnancy rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with a history of recurrent implantation failure
Age less than 45 years
Have at least two three-day-old fetuses
Exclusion criteria:
Having any uterine abnormalities
Age
From 20 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
200
Actual sample size reached:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by generating random numbers in Excel software.
1. In a column of Excel we enter 100 samples in each group.
2. In the next column we generate random numbers using the following command: RAND ()
3. After sorting the generated random numbers, a random list will be generated according to which people will be assigned to two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blindness will be such that the patient will not know what treatment she will receive. Also, the researcher who records the results will not be aware of the type of treatment applied to the patient
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی شهید بهشتی
Street address
Velenjak, Yaman St, Chamran highway
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2022-03-05, 1400/12/14
Ethics committee reference number
IR.SBMU.REC.1400.024
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
clinical pregnancy
Timepoint
5-7 weeks of gestation
Method of measurement
sonography
Secondary outcomes
1
Description
ongoing pregnancy
Timepoint
20 weeks of gestation
Method of measurement
Ultrasonography
2
Description
clinical abortion
Timepoint
20 weeks of gestation
Method of measurement
Ultrasonography
Intervention groups
1
Description
Intervention group: In the two-stage embryo transfer group, one embryo is transferred in the cleavage stage on the third day and then on the 5th day, one embryo is transferred in the blastocyst stage. All embryos are transferred under ultrasound guidance using a soft catheter.
Category
Treatment - Other
2
Description
Control group: Both embryos, under ultrasound guidance using a soft catheter, are transferred to the blastocyst stage on day 5
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility and IVF unit of Talghani hospital
Full name of responsible person
saghar salehpour
Street address
بزرگراه چمران، خیابان یمن، ولنجک، بیمارستان آیت الله طالقانی
City
Tehran
Province
Tehran
Postal code
1985717413
Phone
+98 915 173 7362
Email
saghar.salehpour2014@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
saghar salehpour
Street address
Shahid Beheshti University of Medical Sciences, Yaman st., Velenjak, Chamran highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 2558
Email
Saghar.salehpour2014@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?