Transabdominal US-guided (UGET) vs. Modified Transvaginal US-guided (mTVET) Embryo Transfer in Human IVF

NCT02526472 | Completed

• 1 other identifier: FDR-2-2015
• Study Type: interventional
• Target: 1,648
• Locations: 1 country
• Sites: 1

Brief Summary

One thousand, six hundred forty-eight IVF patients undergoing ET with fresh embryos, randomized to receive mTVET (n=828) or UGET (n=820). The transfer in uteri of 1-2 embryos on day 2-3 of culture was performed using a soft catheter either under trans-abdominal US guidance (UGET group) or after measurement of uterine cavity by transvaginal US and calculation of the discharge site (mTVET). Mai outcome measures was the clinical pregnancy rate (CPR), secondary outcomes were the implantation rate (IR), and the patient's discomfort during ET procedure.

Conditions

Infertility

Keywords

embryo transfer, in vitro fertilization

Outcome Measures

Primary Outcomes (2)

• clinical pregnancy rate per embryo transfer (CPR/ET)

  3 years

• implantation rate

  3 weeks (until the pregnancy test is performed)

Secondary Outcomes (1)

• proportion of patients feeling moderate-to-severe discomfort during ET

  3 years

Study Arms (2)

transabdominal US guidance (UGET)

EXPERIMENTAL

ET under transabdominal US guidance (UGET)

Procedure: ET under transabdominal US guidance (UGET)

TV-US ET guidance (mTVET)

EXPERIMENTAL

ET after transvaginal US uterine measurement (mTVET)

Procedure: ET after transvaginal US uterine measurement (mTVET)

Interventions

ET under transabdominal US guidance (UGET) PROCEDURE

When UGET was used, a second physician performed trans-abdominal US, and the embryos were discharged when the tip of the catheter was visualized approximately at 1,5 cm from the fundal endometrial surface

transabdominal US guidance (UGET)

ET after transvaginal US uterine measurement (mTVET) PROCEDURE

When mTVET was scheduled, the physician performed a transvaginal US scan just before ET, measured the length of the cervix and of the uterine cavity, and calculated the distance between the internal uterine os and the fundal endometrial surface. Then, ET was performed inserting the inner cannula in order to discharge embryos at a point obtained subtracting 1.5 cm from the total length of the cavity.

TV-US ET guidance (mTVET)

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients undergoing autologous IVF
• ending IVF cycle with the transfer of fresh embryos
• treated at the investigators'r IVF Unit between Jan 2012 to Dec 2014

You may not qualify if:

• patients undergoing donor IVF
• ending IVF cycle without embryo transfer
• transferring frozen-thawed embryos
• treated elsewhere

Sponsors & Collaborators

• University of Turin, Italy: lead

Study Sites (1)

Physiopathology of Reproduction and IVF Unit, S. Anna Hospital

Torino, 10126, Italy

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Alberto Revelli, Prof.

  Dept. Surgical Sciences, Sant'Anna Hospital, University of Torino, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: August 18, 2015
• Study Start: January 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 18, 2015

Record last verified: 2015-08

Locations

IT (1)