NCT04408547

Brief Summary

Analysis our Embryo transfer data, prospectively collected during the last 6 years (2014- 2019), performed by the same operator YP, who has been doing embryo transfers since 1984. All factors that might impact the embryo transfer will be analyzed. We want to see which factors that influence the success rate are not related to the subjectivity of the operator and could be adjusted through different approaches.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,512

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

January 3, 2014

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2020

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
Last Updated

June 4, 2020

Status Verified

May 1, 2020

Enrollment Period

6 years

First QC Date

May 13, 2020

Last Update Submit

June 1, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Number of patients with bhCG positive test after embryo transfer

    Number of patients bhCG positive up to12 days after embryo transfer

    Number of patients bhCG positive up to12 days after embryo transfer

  • Number of patients with on going clinical pregnancy

    Number of patients with on going clinical pregnancy up to12 weeks after embryo transfer

    Number of patients with on going clinical pregnancy up to 12 weeks after embryo transfer

  • Number of live births after embryo transfer

    Number oflive birth up to9 months after embryo transfer

    Number oflive birth up to 9 months after embryo transfer

Secondary Outcomes (6)

  • Percentage of fullnes of bladder

    At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer

  • Endometrial thickness

    prior to embryo transfer

  • Uterine axe orientation

    At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer

  • Type of embryo transfer catheter

    At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer

  • Distance from the fundus of the embryo release

    At the time of embryo transfer and the impact of pregnancy test result 12 days after the mebryo transfer

  • +1 more secondary outcomes

Study Arms (2)

soft catheter

Patients who underwent embryo transfer with a soft catheter

Device: embryo transfer catheter

stiff catheter

Patients who underwent embryo transfer with a stiff catheter because soft couldn't pass

Device: embryo transfer catheter

Interventions

undergoing embryo transfer

soft catheterstiff catheter

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly women can undergo embryo transfer
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women undergoing embryo transfer after IVF

You may qualify if:

  • Women undergoing embryo transfer after IVF

You may not qualify if:

  • Women with known embryo implantation issues

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IAKENTRO Fertility Center

Thessaloniki, 542 50, Greece

Location

Related Publications (1)

  • Prapas N, Prapas Y, Panagiotidis Y, Prapa S, Vanderzwalmen P, Makedos G. Cervical dilatation has a positive impact on the outcome of IVF in randomly assigned cases having two previous difficult embryo transfers. Hum Reprod. 2004 Aug;19(8):1791-5. doi: 10.1093/humrep/deh320. Epub 2004 Jun 3.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Obstetrics - Gynaecology

Study Record Dates

First Submitted

May 13, 2020

First Posted

May 29, 2020

Study Start

January 3, 2014

Primary Completion

December 30, 2019

Study Completion

December 30, 2019

Last Updated

June 4, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations