Back to resultsTransvaginal Ultrasonography Guided Embryo Transfer
Primary Purpose
Infertility, Female
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
transabdominal ultrasound guided embryo transfer
transvaginal ultrasound guided embryo transfer
Sponsored by
About this trial
This is an interventional treatment trial for Infertility, Female focused on measuring obesity, embryo transfer, invitro fertilization
Eligibility Criteria
Inclusion Criteria:
- BMI more than 35, good ovarian reserve, unexplained infertility more than 3 years.
Exclusion Criteria:
- severe male factor of infertility,uterine factor of infertility excluded by ultrasonography and hysteroscopy ,ovarian endometrioma or patients with poly cystic ovary syndrome, obesity caused by abnormal endocrine function (thyroid or adrenal disorder)
Sites / Locations
- Kasr El Ainiy Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
transabdominal ultrasound
transvaginal group
Arm Description
400 obese female undergo transabdominal ultrasound guided embryo transfer
400 obese female undergo transvaginal ultrasound guided embryo transfer
Outcomes
Primary Outcome Measures
clinical pregnancy rate'
the presence of at least one intrauterine gestational sac with viable fetus.
Secondary Outcome Measures
live birth rate
delivery of a living baby
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03473028
Brief Title
Transvaginal Ultrasonography Guided Embryo Transfer
Official Title
Could Transvaginal Ultrasonography Guided Embryo Transfer Improves Pregnancy Outcome in Obese Patients Undergoing Intracytoplasmic Sperm Inoculation? Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
February 18, 2021 (Actual)
Study Completion Date
March 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kasr El Aini Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
to evaluate the value of using transvaginal ultrasound guided embryo transfer in obese patients undergoing in vitro fertilization.
Detailed Description
The 800 participants with body mass index more than 30kg/m2 were randomly allocated to two groups of equal size using an automated web-based randomization system. The first group 400 patient undergoing the transabdominal-guided embryo transfer, the second group 400 patient undergoing transvaginal-guided embryo transfer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
Keywords
obesity, embryo transfer, invitro fertilization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
800 (Actual)
8. Arms, Groups, and Interventions
Arm Title
transabdominal ultrasound
Arm Type
Active Comparator
Arm Description
400 obese female undergo transabdominal ultrasound guided embryo transfer
Arm Title
transvaginal group
Arm Type
Active Comparator
Arm Description
400 obese female undergo transvaginal ultrasound guided embryo transfer
Intervention Type
Procedure
Intervention Name(s)
transabdominal ultrasound guided embryo transfer
Intervention Description
400 female with body mass index more than 30undergo transabdominal ultrasound guided embryo transfer
Intervention Type
Procedure
Intervention Name(s)
transvaginal ultrasound guided embryo transfer
Intervention Description
400 female with body mass index more than 30 undergo transvaginal ultrasound guided embryo transfer
Primary Outcome Measure Information:
Title
clinical pregnancy rate'
Description
the presence of at least one intrauterine gestational sac with viable fetus.
Time Frame
4 weeks following embryo transfer
Secondary Outcome Measure Information:
Title
live birth rate
Description
delivery of a living baby
Time Frame
immediately following delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
BMI more than 35, good ovarian reserve, unexplained infertility more than 3 years.
Exclusion Criteria:
severe male factor of infertility,uterine factor of infertility excluded by ultrasonography and hysteroscopy ,ovarian endometrioma or patients with poly cystic ovary syndrome, obesity caused by abnormal endocrine function (thyroid or adrenal disorder)
Facility Information:
Facility Name
Kasr El Ainiy Hospital
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
34584462
Citation
Mohamed Hassan S, Ramadan W, Elsharkawy M, Ali Bayoumi Y. The Role of Transvaginal Ultrasound Guided Embryo Transfer to Improve Pregnancy Rate in Obese Patients Undergoing Intracytoplasmic Sperm Injection. Int J Womens Health. 2021 Sep 21;13:861-867. doi: 10.2147/IJWH.S325557. eCollection 2021.
Results Reference
derived
Learn more about this trial
Transvaginal Ultrasonography Guided Embryo Transfer
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