NCT03851536

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2016

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2019

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 22, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2019

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

2.7 years

First QC Date

February 5, 2019

Last Update Submit

March 11, 2019

Conditions

Infertility

Keywords

Embryo TransferICSITransvaginal Ultrasound

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy

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

    3 weeks after Embryo transfer

Secondary Outcomes (3)

  • Time required for ET

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

  • Degree of cramping and pain

    During and immediately after ET

  • Endometrial visualization at time of embryo transfer

    During ET

Study Arms (2)

Transvaginal Ultrasound Guided ET

EXPERIMENTAL

Transvaginal ultrasound is used to guide ET

Procedure: Transvaginal Ultrasound Guided ET

Transabdominal Ultrasound Guided ET

EXPERIMENTAL

Transabdominal ultrasound is used to guide ET

Procedure: Transabdominal Ultrasound Guided ET

Interventions

Transvaginal Ultrasound Guided ETPROCEDURE

Use of TVUS to guide ET

Also known as: Transvaginal US guided ET
Transvaginal Ultrasound Guided ET
Transabdominal Ultrasound Guided ETPROCEDURE

Use of TAUS to guide ET

Also known as: Transabdominal US guided ET
Transabdominal Ultrasound Guided ET

Eligibility Criteria

Age20 Years - 42 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsA procedure performed only in females
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Menoufia University

Shibīn al Kawm, Monofiya, 32511, Egypt

Location

Alexandria University

Alexandria, 94109, Egypt

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Mohamad S kandil, MD

    Menoufia University

    STUDY CHAIR

  • Sherif S Gaafar, MD

    Alexandria University

    STUDY DIRECTOR

  • Haitham A Hamza, MD

    Menoufia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Obstetrics and Gynecology

Study Record Dates

First Submitted

February 5, 2019

First Posted

February 22, 2019

Study Start

June 2, 2016

Primary Completion

February 15, 2019

Study Completion

March 9, 2019

Last Updated

March 12, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)