Infertility Clinical Trial
Official title:
Embryo Transfer: Embryo Expulsion and Outcome
According to the studies, about 80% of patients undergoing in vitro
fertilization/intracytoplasmic sperm injection (IVF/ICSI) reach to the embryo transfer
process, but only a few of them become pregnant.
The cause of this difference can be due to some factors such as the endometrial receptivity,
quality of transferred embryos and embryo transfer technique. Retained or expelled embryo(s)
following embryo transfer is (are) one of the factors which may be effective on outcome. The
purpose of this randomized clinical trial study is "Lowering embryo expulsion following
embryo transfer to improve outcome."
A total of 134 infertile women who undergo IVF or ICSI treatment cycle at Royan Institute
(Infertility and Reproductive Medicine Research Centre) will enroll in this prospective
randomized clinical trial study and will randomly be divided into two groups of 67 patients.
This study has been approved by Royan ethics committee and written consent will be obtained
from each patient. The patients with frozen-thawed embryo transfer cycle and those with
oocyte donation cycle, the women with uterine abnormality and the subjects with submucosal
and intramural myoma, will be excluded from this study.
After the ovarian stimulation and oocyte retrieval, The IVF and intracytoplasmic sperm
injection (ICSI) procedures will be performed to produce the embryos.
Embryo transfer will be done only by one skilled physician. The patients will be divided
into two groups of A and B by computerized randomly chart. In group A, the prevention
technique of embryo expulsion will be carried out following embryo transfer, but no
intervention will be performed in group B (control group).
After 2 weeks, the patients will be tested for serum β-hCG for assessing the pregnancy. The
clinical pregnancy will be clarified by the number of women with gestational sacs on
transvaginal sonography at 4-6 weeks of gestation. In the calculation of implantation, the
number of gestational sacs will be considered.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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