evaluation of the twice embryo transfer on day 3 or day 5 (blastocyst) compared with the embryo transfer on the fifth day in women with a history of at least three failed IVF
Design
The third phase of this randomized clinical trial, two groups of 120 subjects were assigned to two parallel groups of intervention (embryo transfer on days 3 and 5) and control (embryo transfer on the fifth day (blastocyst).
Settings and conduct
Published data on sequential transfer is limited. Also, the effectiveness of this procedure is still a matter of debate. So, this study was aimed to evaluate the sequential embryo transfer on day 3 or day 5-blastocyst compared to single transfer on day 5 ( blastocyst ) in women with a history of at least three IVF failures referred to Imam Khomeini Infertility clinic.
After the ovarian stimulation, oocyte retrieval, inoculation of sperm into the oocyte and embryo formation, The included patients were randomly divided into two groups. In the intervention group, 1 number of the embryo was transferred on the third day and two embryos on the fifth day (blastocyst) and in the control group, two blastocysts were transferred to the uterus.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Women with less than 40 years of age with more than three times IVF failure, normal karyotype, immunological status and thrombophilia, lack of anomalies in the endometrium.
Exclusion criteria: patients with poor or ovarian hyperstimulation syndrome, underlying medical conditions.
Intervention groups
Intervention group: In the number of 60 eligible patients after ovulation stimulation and embryo formation, the embryos were transferred to the third and fifth days on two occasions
Control group: Two embryos were transferred to fifth days on one occasion.
Main outcome variables
Chemical pregnancy ؛ Clinical Pregnancy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141217020351N10
Registration date:2018-05-13, 1397/02/23
Registration timing:retrospective
Last update:2018-05-13, 1397/02/23
Update count:0
Registration date
2018-05-13, 1397/02/23
Registrant information
Name
Ensieh Shahrogh Tehraninejad
Name of organization / entity
Tehran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1616
Email address
etehraninejad@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-04-09, 1394/01/20
Expected recruitment end date
2016-04-08, 1395/01/20
Actual recruitment start date
2015-04-09, 1394/01/20
Actual recruitment end date
2016-04-08, 1395/01/20
Trial completion date
empty
Scientific title
The sequential embryo transfer in the third and fifth day compared to single embryo transfer in the fifth day in IVF cycle
Public title
The sequential embryo transfer compared to single embryo transfer in one cycle
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age ≤ 40 years
normal karyotype
normal screening of immunological and thrombolytic condition
the absence of endometrial abnormalities by hysteroscopy
availability of ≥5 embryos
Exclusion criteria:
potential poor responders
Ovarian hyper stimulation response
presence of medical diseases
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
130
Actual sample size reached:
120
Randomization (investigator's opinion)
Randomized
Randomization description
they were allocated to one of two groups via simple random sampling, using a random Pocket (intervention or Control)by the same coordinator.Patients were allocated to either sequential transfer (day 3 and day 5) or conventional transfer (day 5) protocols.
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
No.6,Ghods Ave,Keshavarz Blvd,Deputy of Research of Tehran University of Medical Sciences
Six weeks after seeing the embryo sac in ultrasound
Method of measurement
Ultrasonography
Secondary outcomes
1
Description
Abortion
Timepoint
After positive pregnancy test
Method of measurement
Blood sample of B-HCG
2
Description
Ectopic pregnancy
Timepoint
After the positive of pregnancy test
Method of measurement
Sonography
Intervention groups
1
Description
Intervention group: patients were randomized to one of the 2 groups of Intervention and control .After ovulation induction, ٌWhen 3leading follicles reached more than 17 mm diameter means, oocyte retrieval was performed 36 hours later under the unconscious sedation. The retrieved oocytes were incubated in a mini-incubator with the triple gas mixture for 3h in a fertilization medium and then ICSI was done. Injected oocytes were transferred to a culture dish with cleavage medium (Sydney IVF cleavage medium, cook ). Fertilization was assessed 16-18 h after ICSI and then observed for cleavage on day 3. Once post-fertilization check confirmed availability of ≥5 embryos, . In the third day after injection, embryo quality was evaluated, and 1 good-quality embryos were transferred (Cleavage in fresh cycles). Also, embryos were transferred to Blastocyst medium (Sydney IVF blastocyst medium) for 48 h. Then, on the fifth day, two embryos (Blastocyst) were transferred to the uterus.
Category
Treatment - Surgery
2
Description
Control group: After ovulation induction, ٌWhen 3leading follicles reached more than 17 mm diameter means, oocyte retrieval was performed 36 hours later under the unconscious sedation. The retrieved oocytes were incubated in a mini-incubator with the triple gas mixture for 3h in a fertilization medium and then ICSI was done. Injected oocytes were transferred to a culture dish with cleavage medium (Sydney IVF cleavage medium, cook ). Fertilization was assessed 16-18 h after ICSI and then observed for cleavage on day 3. Once post-fertilization check confirmed availability of ≥5 embryos, In the control group, on the fifth day, two embryos (Blastocyst) were transferred to the uterus.