Comparison between the effect of conventional embryo transfer and embryo transfer based on previously measured uterine length on pregnancy and implantation rates in fresh ART cycles in IVF ward of Taleghani Hospital
Objectives:
Comparison between the effect of conventional embryo transfer and embryo transfer based on previously measured uterine length on pregnancy and implantation rates in fresh ART cycles. Embryo transfer is one of the most important steps in Assisted Reproductive Technology cycles and is affected by many factors, namely the depth of embryo deposition in uterus. In this study the outcome of Intracytoplasmic Sperm Injection (ICSI) cycles after blind embryo transfer and embryo transfer based on previously measured uterine length using vaginal ultrasound are compared.
Design:
This study is a prospective single blind randomized (based on the odd ever days ) clinical trial.
Setting and conduct:
Infertility & Reproductive Health Research Centre Shahid Beheshti University of Medical Science-Thaleghani hospital
Participants:
All of the ART cycles including agonist and antagonist from the date of 31.12.2009 to 31.5.2011
One hundred and forty non donor fresh embryo transfers were included.
interventions:
The embryo transfer in group I (control group) is performed using conventional (blind) method at 5-6cm from the external os based on physician experience and in group II (intervention group) is done at a depth of 1-1.5cm from the end of uterine cavity based on previously measured uterine length, using vaginal sonography at the day of HCG injection
Appropriate statistical analysis is performed using Student's t-test
and Chi-square or Fisher's exact test.the software that we use is PASW statistics version18. P-value<o.o5 is considered statistically significant.
Main outcomes:
Chemical pregnancy rate; Clinical pregnancy rate; ongoing pregnancy rate implantation rate and abortion rate. those are measured by serum B-HCG and ultrasonography
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014032512494N1
Registration date:2014-03-25, 1393/01/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-03-25, 1393/01/05
Registrant information
Name
Nasrin Saharkhiz
Name of organization / entity
Infertility & Reproductive Health Research Centre of SHahid Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2558
Email address
saharkhiz.n@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2009-12-31, 1388/10/10
Expected recruitment end date
2011-05-31, 1390/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the effect of conventional embryo transfer and embryo transfer based on previously measured uterine length on pregnancy and implantation rates in fresh ART cycles in IVF ward of Taleghani Hospital
Public title
Comparison between conventional blind embryo transfer and embryo transfer based on previously measured uterine length
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All the patients who underwent ICSI in this period of time in our center that reached the embryo transfer step, were enrolled in the study.
Exclusion criteria :
Egg donation cycles; embryo donation cycles; frozen embryo transfers were excluded.
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
not have
Secondary trial Id
not have
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Infertility & Reproductive Health Research Center Ethics committee of Shahid Beheshti University of
Number of gestational sacs at vaginal sonography divided by total number of transfered embryos
Secondary outcomes
1
Description
Abortion rate
Timepoint
First trimester
Method of measurement
Clinical sign and vaginal ultrasound
2
Description
Ectopic pregnancy rate
Timepoint
First trimester
Method of measurement
Clinical sign and vaginal ultrasound
Intervention groups
1
Description
In intervention group:
The type of stimulatory cycle (Agonist or Antagonist) were selected based on the age of woman and other factores. (agonist;Superfact:
mination Hoechst, Frankfurt, Germany)antagonist;cetrotide,EMDSerono,inc).Ovarian stimulation was done using r-FSH (GonalF;Serono,Laboratories.Ltd,Geneva,Switzerland),Merional or Fostimon ( IBSA,Switzerland), single or in combination.
When the leading follicles reachd 17-18mm in diameter HCG 10,000 unit (IBSA,Switzerland) was administered. The uterine length was measured, on the day of HCG administration, by recording the distance from the external os to the uterine fundus using vaginal sonography. Oocyte retrieval was performed 34-36 hours later. The day of embryo transfer is determined by convenience after 48-72 h.
Procedure:
All women are placed in the lithotomy position (with an empty bladder) and a sterile metal speculum is placed to expose the cervix. The cervical mucus is cleaned using ringer solution and then the external os is washed with media (ham’s F 10 liquid).In all cases a Cook catheter ( COOK medical USA ) are used. First the outer catheter and then the inner catheter that load the embryos is placed. The site of embryo deposition in the uterus is determined based on uterine length measurement by vaginal ultrasound at the day of HCG and embryo deposition is done in depth of 1-1.5 cm from the end of uterine cavity .
Category
Other
2
Description
In control group:
The type of stimulatory cycle (Agonist or Antagonist) are selected based on the age of woman and other factores. (agonist;Superfact:
mination Hoechst, Frankfurt, Germany)antagonist;cetrotide,EMDSerono,inc).Ovarian stimulation is done using r-FSH (GonalF;Serono,Laboratories.Ltd,Geneva,Switzerland),Merional or Fostimon ( IBSA,Switzerland), single or in combination.
When the leading follicles reachd 17-18mm in diameter HCG 10,000 unit (IBSA,Switzerland) is administered. The uterine length is measured, on the day of HCG administration, by recording the distance from the external os to the uterine fundus using vaginal sonography. Oocyte retrieval is performed 34-36 hours later. The day of embryo transfer is determined by convenience ,after 48 or 72h.
Procedure:
All women are placed in the lithotomy position (with an empty bladder) and a sterile metal speculum is placed to expose the cervix. The cervical mucus is cleaned using ringer solution and then the external os is washed with media (ham’s F 10 liquid).In all cases a Cook catheter ( COOK medical USA ) are used. First the outer catheter and then the inner catheter that loaded the embryos is placed. In this group embryos are blindly deposited at the middle portion of the uterine cavity approximately at 5-6cm distance from the external os and based on physician experience.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility & Reproductive Health Research Center Shahid Beheshti University of Medical Science