Embryo Transfer: Embryo Expulsion and Outcome
Primary Purpose
Infertility
Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
prevention of embryo expulsion
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Embryo transfer, IVF/ICSI, Embryo expulsion
Eligibility Criteria
Inclusion Criteria:
- Women undergoing IVF or ICSI treatment cycle
- Patients with "long or antagonist" protocol
Exclusion Criteria:
- The patients with frozen-thawed embryo transfer cycle
- Those with oocyte donation cycle
- The women with uterine abnormality
- The women with submucosal and intramural myoma
- Who does not have good-quality embryos appropriate
Sites / Locations
- Royan Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Embryo Expulsion
Arm Description
Embryo transfer without any intervention
Outcomes
Primary Outcome Measures
Clinical pregnancy
Secondary Outcome Measures
Implantation rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00905788
Brief Title
Embryo Transfer: Embryo Expulsion and Outcome
Official Title
Embryo Transfer: Embryo Expulsion and Outcome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Royan Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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."
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Embryo transfer, IVF/ICSI, Embryo expulsion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Embryo transfer without any intervention
Arm Title
Embryo Expulsion
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
prevention of embryo expulsion
Intervention Description
The prevention of embryo expulsion will be carried out after embryo transfer
Primary Outcome Measure Information:
Title
Clinical pregnancy
Time Frame
4-6 weeks
Secondary Outcome Measure Information:
Title
Implantation rate
Time Frame
6-7 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women undergoing IVF or ICSI treatment cycle
Patients with "long or antagonist" protocol
Exclusion Criteria:
The patients with frozen-thawed embryo transfer cycle
Those with oocyte donation cycle
The women with uterine abnormality
The women with submucosal and intramural myoma
Who does not have good-quality embryos appropriate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tahere Madani, MD
Organizational Affiliation
Royan Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mahnaz Ashrafi, MD
Organizational Affiliation
Royan Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royan Institute
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Links:
URL
http://www.royaninstitute.org
Description
Official site
Learn more about this trial
Embryo Transfer: Embryo Expulsion and Outcome
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