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Ultrasound Guidance for Embryo Transfer

Primary Purpose

Infertility

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Transvaginal Ultrasound Guided ET

Transabdominal Ultrasound Guided ET

About this trial

This is an interventional treatment trial for Infertility focused on measuring Embryo Transfer, ICSI, Transvaginal Ultrasound

Eligibility Criteria

20 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

All patients undergoing autologous ICSI and frozen embryo transfer (FET) cycles.

Exclusion Criteria:

Cases of sever ovarian hyperstimulation requiring embryo cryopreservation
Gestational surrogate cycles
Oocyte donation cycles
Very poor responders
Patients with inadequate visualization of the uterus by ultrasound.
Very difficult mock embryo transfer.

Sites / Locations

Menoufia University
Alexandria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Transvaginal Ultrasound Guided ET

Transabdominal Ultrasound Guided ET

Arm Description

Transvaginal ultrasound is used to guide ET

Transabdominal ultrasound is used to guide ET

Outcomes

Primary Outcome Measures

Clinical pregnancy

A clinical pregnancy is a pregnancy that is confirmed by ultrasonic visualization of gestational sac or heartbeat.

Secondary Outcome Measures

Time required for ET

Time in seconds required for ET

Degree of cramping and pain

Degree of cramping and pain from 0 to 10 by visual analogue scale (VAS) where 0 is no pain and 10 unbearable pain.

Endometrial visualization at time of embryo transfer

Endometrial visualization at time of embryo transfer by ultrasound

Full Information

NCT ID

NCT03851536

First Posted

February 5, 2019

Last Updated

March 11, 2019

Sponsor

Menoufia University

Collaborators

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT03851536

Brief Title

Ultrasound Guidance for Embryo Transfer

Official Title

Transvaginal Versus Transabdominal Ultrasound Guided Embryo Transfer. Randomized Controlled Trial.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

June 2, 2016 (Actual)

Primary Completion Date

February 15, 2019 (Actual)

Study Completion Date

March 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Menoufia University

Collaborators

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Randomized controlled study comparing the TVUS versus TAUS guidance during the procedure of embryo transfer.

Detailed Description

The aim of this study was to Compare between transvaginal and transabdominal ultrasound guided embryo transfer as regarding clinical pregnancy rate, patient comfort, time required for embryo transfer and endometrial visualization at time of embryo transfer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

Embryo Transfer, ICSI, Transvaginal Ultrasound

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

178 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Transvaginal Ultrasound Guided ET

Arm Type

Experimental

Arm Description

Transvaginal ultrasound is used to guide ET

Arm Title

Transabdominal Ultrasound Guided ET

Arm Type

Experimental

Arm Description

Transabdominal ultrasound is used to guide ET

Intervention Type

Procedure

Intervention Name(s)

Transvaginal Ultrasound Guided ET

Other Intervention Name(s)

Transvaginal US guided ET

Intervention Description

Use of TVUS to guide ET

Intervention Type

Procedure

Intervention Name(s)

Transabdominal Ultrasound Guided ET

Other Intervention Name(s)

Transabdominal US guided ET

Intervention Description

Use of TAUS to guide ET

Primary Outcome Measure Information:

Title

Clinical pregnancy

Description

A clinical pregnancy is a pregnancy that is confirmed by ultrasonic visualization of gestational sac or heartbeat.

Time Frame

3 weeks after Embryo transfer

Secondary Outcome Measure Information:

Title

Time required for ET

Description

Time in seconds required for ET

Time Frame

Time from when the catheter is handed to the transferring physician to the time it is returned to the transferring embryologist.

Title

Degree of cramping and pain

Description

Degree of cramping and pain from 0 to 10 by visual analogue scale (VAS) where 0 is no pain and 10 unbearable pain.

Time Frame

During and immediately after ET

Title

Endometrial visualization at time of embryo transfer

Description

Endometrial visualization at time of embryo transfer by ultrasound

Time Frame

During ET

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

A procedure performed only in females

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

42 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: All patients undergoing autologous ICSI and frozen embryo transfer (FET) cycles. Exclusion Criteria: Cases of sever ovarian hyperstimulation requiring embryo cryopreservation Gestational surrogate cycles Oocyte donation cycles Very poor responders Patients with inadequate visualization of the uterus by ultrasound. Very difficult mock embryo transfer.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamad S kandil, MD

Organizational Affiliation

Menoufia University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Sherif S Gaafar, MD

Organizational Affiliation

Alexandria University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Haitham A Hamza, MD

Organizational Affiliation

Menoufia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Menoufia University

City

Shibīn Al Kawm

State/Province

Monofiya

ZIP/Postal Code

32511

Country

Egypt

Facility Name

Alexandria University

City

Alexandria

ZIP/Postal Code

94109

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Ultrasound Guidance for Embryo Transfer

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