Transvaginal Ultrasonography Guided Embryo Transfer

April 6, 2021 updated by: sarah mohamed hassan, Kasr El Aini Hospital

Could Transvaginal Ultrasonography Guided Embryo Transfer Improves Pregnancy Outcome in Obese Patients Undergoing Intracytoplasmic Sperm Inoculation? Randomized Controlled Study

to evaluate the value of using transvaginal ultrasound guided embryo transfer in obese patients undergoing in vitro fertilization.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11562
        • Kasr El Ainiy Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: transabdominal ultrasound
400 obese female undergo transabdominal ultrasound guided embryo transfer
Procedure: transabdominal ultrasound guided embryo transfer
400 female with body mass index more than 30undergo transabdominal ultrasound guided embryo transfer
ACTIVE_COMPARATOR: transvaginal group
400 obese female undergo transvaginal ultrasound guided embryo transfer
Procedure: transvaginal ultrasound guided embryo transfer
400 female with body mass index more than 30 undergo transvaginal ultrasound guided embryo transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical pregnancy rate'
Time Frame: 4 weeks following embryo transfer
the presence of at least one intrauterine gestational sac with viable fetus.
4 weeks following embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
live birth rate
Time Frame: immediately following delivery
delivery of a living baby
immediately following delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kasr El Aini Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2018

Primary Completion (ACTUAL)

February 18, 2021

Study Completion (ACTUAL)

March 4, 2021

Study Registration Dates

First Submitted

March 15, 2018

First Submitted That Met QC Criteria

March 20, 2018

First Posted (ACTUAL)

March 21, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019 (Chief Medical Office (CMO) Alberta Health Services)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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