NCT03756857

Brief Summary

Prospective, open, randomized, parallel, two-arm trial to compare the clinical pregnancy rate between most commonly used two embryo transfer techniques: trial followed by transfer technique and afterloading technique

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

January 21, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

2.6 years

First QC Date

November 27, 2018

Last Update Submit

March 21, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • clinical pregnancy rate

    the presence of gestational sac on ultrasound

    5-6 weeks after embryo transfer

Secondary Outcomes (1)

  • implantation rate

    3-4 weeks after embryo transfer

Study Arms (2)

Afterload transfer

EXPERIMENTAL

First, an empty catheter passes to the level of the lower uterine segment under ultrasound guidance to a point where the inner catheter enters the endometrial cavity. The inner sheath is removed slowly, leaving the outer sheath just beyond the internal os. After verifying the catheter's position on the TA ultrasound scan, the physician gives the signal to the embryologist to start the embryo loading. The embryologist brings the loaded inner catheter and inserts it into the outer sheath, which is maintained in its position by the physician.

Procedure: Afterload Transfer

Trial Followed by Transfer

EXPERIMENTAL

First a trial transfer is performed using both the inner catheter and outer sheath connected together in standard configuration, just before the actual embryo transfer. It is passed up to and just through the the internal os. When it appears that the actual transfer will be possible without great difficulty ,the trial catheter is withdrawn. An embryo transfer catheter is loaded and the actual transfer is performed

Procedure: Trial followed by transfer

Interventions

Embryo transfer is done by using "afterload transfer" method

Afterload transfer

Embryo transfer is done by using "afterload transfer" method

Trial Followed by Transfer

Eligibility Criteria

Age20 Years - 37 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patient has given written informed consent
  • BMI 18-30 kg/m2
  • \< 2 previous failed IVF trials
  • At least two good quality embryos on the day of transfer

You may not qualify if:

  • Congenital uterine anomaly
  • Untreated endometrial polyp or fibroid distorting uterine cavity
  • Presence of hydrosalpinx 4.2 or more prior IVF trial failure
  • Moderate to severe endometriosis 6.Recurrent pregnancy loss history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acibadem Altunizade Hospital, Unit of ART

Istanbul, 34662, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Central Study Contacts

Elif Esra UYAR, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, open, randomized, parallel, two-arm trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

November 27, 2018

First Posted

November 28, 2018

Study Start

January 21, 2019

Primary Completion

September 1, 2021

Study Completion

December 1, 2021

Last Updated

March 23, 2021

Record last verified: 2021-03

Locations