Embryo Transfer: Embryo Expulsion and Outcome
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|ClinicalTrials.gov Identifier: NCT00905788|
Recruitment Status : Completed
First Posted : May 21, 2009
Last Update Posted : April 20, 2010
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."
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Procedure: prevention of embryo expulsion||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||134 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Embryo Transfer: Embryo Expulsion and Outcome|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||December 2009|
No Intervention: Control Group
Embryo transfer without any intervention
|Experimental: Embryo Expulsion||
Procedure: prevention of embryo expulsion
The prevention of embryo expulsion will be carried out after embryo transfer
- Clinical pregnancy [ Time Frame: 4-6 weeks ]
- Implantation rate [ Time Frame: 6-7 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905788
|Iran, Islamic Republic of|
|Tehran, Iran, Islamic Republic of|
|Principal Investigator:||Tahere Madani, MD||Royan Institute|
|Principal Investigator:||Mahnaz Ashrafi, MD||Royan Institute|