Investigation of intrauterine saline infusion at day 3 to 5 of ovarian stimulation on the clinical outcome of Intracytoplasmic sperm injection- embryo transfer cycles in patients with repeated implantation failure.
Objective: to investigate the effect of normal saline infusion into the uterine cavity on clinical pregnancy and implantation and abortion rate in ovarian stimulation cycles of intracytoplasmic sperm injection cycles -embryo transfer in patients with recurrent implantation failure.
Design: Randomized Clinical Trial.
Setting and conduct and participants including major eligibility: in patients aged 20-45 years who have failed two or more intracytoplassmic sperm injection-embryo transfer cycles despite transfer of good quality embryos and Now undergoing intracytoplasmic sperm injection -embryo transfer or freeze embryo transfer cycles, Have normal hysterosalpingography or hysteroscopy are included in study.
Intervention: during the fresh intracytoplassmic sperm injection-embryo transfer cycles or next freeze embryo transfer cycle, Or cycles continue without any interventions or on stimulation days 3 to 5 in fresh cycles and on day 3 to 5 from starting of oral estradiol in freeze embryo transfer cycles, randomly we are injecting 20 CC of normal saline by intrauterine insemination catheter under ultrasonography guide in to the uterine cavity and then suctioning it and then in both groups, in fresh intracytoplassmic sperm injection-embryo transfer cycles with gonadothropins injection and if necessary Antagonist will be continue and when 2 or 3 follicles reach to a diameter of 17 mm, 10,000 units of human chorionic gonadotropin ampoules will be injected and oocyte retrieval will be performed 34 to 36 hours later and in freeze embryo transfer group continuing estradiol and when endometrial thickness are receiving to 7 millimeter, then starting suppository vaginal progesterone 400 milligram twice daily and three days after oocyte injection in fresh cycles and on day 4 of progesterone administration, 2 to 3 embryos that have 6-8 cells are transferring through the vagina into the patients uterus.
Main outcome measure (variables criteria): 15 days after embryo transfer, chemical pregnancy will be confirmed or rule out by positive BHCG test and 3-4 weeks later; the clinical pregnancy with vaginal ultrasound and then we will compare the pregnancy and the implantation and the miscarriage results between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014120219426N3
Registration date:2014-12-07, 1393/09/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-12-07, 1393/09/16
Registrant information
Name
Saghar Salehpour
Name of organization / entity
Shahid Behshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2558
Email address
saghar.salehpour@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid Beheshti University of Medical Science
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of intrauterine saline infusion at day 3 to 5 of ovarian stimulation on the clinical outcome of Intracytoplasmic sperm injection- embryo transfer cycles in patients with repeated implantation failure.
Public title
Effects of normal salin infusion on pregnancy rate
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: women aged 20-45 years old, undergoing ICSI-ET or freeze embryo transfer; normal hysterosalpingography or hysteroscopy; at least 2 previous failed intracytoplasmic sperm injection-embryo transfer cycles despite transfer of good quality embryos.
Exclusion criteria: abnormal uterine cavity in hysterosalpingography or hysteroscopy; poor responders in previous hormonal stimulation cycles (less than 4 follicles with a size greater than 14 mm on the day of Human chorionic gonadothropin injection).
Age
From 20 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
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
Infertility & Reproductive Health Research Center Ethics committee of Shahid Beheshti University of
Complications associated with artificial fertilization
Primary outcomes
1
Description
Clinical pregnancy
Timepoint
Four weeks after embryo trsnsfer
Method of measurement
Vaginal ultrasonography
Secondary outcomes
1
Description
Chemical pregnancy
Timepoint
Two weeks after embryo transfer
Method of measurement
B HCG kit
2
Description
Ongoing pregnancy
Timepoint
Ten weeks after embryo transfer
Method of measurement
Transabdominal ultrasonography
3
Description
Miscariage rate
Timepoint
22 weeks after embryo transfer
Method of measurement
History, Ultrasonography
Intervention groups
1
Description
Intervention: on days 3 to 5 of the stimulation cycles randomly injecting 20 mL of saline by IUI catheters in to the intrauterine cavity with ultrasound guidance and then suctioned out.
Category
Treatment - Other
2
Description
Control: Stimulation cycles continued without any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility & Reproductive Health Research Center Shahid Beheshti University of Medical Science