NCT03350646

Brief Summary

The aim of this study was to evaluate if higher volume (40-45μl VS 20-25 μl) of media used for embryo transfer affects the clinical outcomes in fresh IVF cycles.Patients who fulfilled the inclusion criteria and agreed to participate in the study, were randomized, on the day of the embryo transfer, into group A: low volume (20-25 μL) and group B: high volume (40-45 μL)

Trial Health

100
On Track

Trial Health Score

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

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

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

November 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 18, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2017

Completed
Last Updated

November 27, 2017

Status Verified

November 1, 2017

Enrollment Period

2.2 years

First QC Date

November 18, 2017

Last Update Submit

November 22, 2017

Conditions

Clinical Pregnancy Rate

Keywords

embryo transfervolumeculture mediumloading the catheterclinical pregnancy rate

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    Number of clinical pregnancies expressed per 100 embryo transfer cycles

    25 days after embryo transfer

Secondary Outcomes (2)

  • Implantation rate

    25 days after embryo transfer

  • Ongoing pregnancy rate

    20 weeks

Study Arms (2)

Low volume (20-25 μl)

OTHER

Low volume (20-25 μl)

Other: Volume of medium during embryo transfer

High volume (40-45 μl)

OTHER

High volume (40-45 μl)

Other: Volume of medium during embryo transfer

Interventions

Volume of medium during embryo transferOTHER
High volume (40-45 μl)Low volume (20-25 μl)

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age ≤ 45y.o.
  • BMI≤36 kg/m2,
  • Baseline FSH concentration \<15 IU/l,
  • Ovarian stimulation with the same GnRH antagonist protocol
  • Normal uterine cavity with endometrium thickness \>7mm and trilaminar morphology at the Time of transfer and semen
  • Parameters of \>1 million /ml motile spermatozoa with \>4% physiological morphology -

You may not qualify if:

  • PGD cycles
  • Frozen -thaw cycles
  • Natural cycles or patients following different ovarian stimulation protocol were excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sigalos GAlpha, Michalopoulos Y, Kastoras AG, Triantafyllidou O, Vlahos NF. Low versus high volume of culture medium during embryo transfer: a randomized clinical trial. J Assist Reprod Genet. 2018 Apr;35(4):693-699. doi: 10.1007/s10815-017-1099-8. Epub 2017 Dec 12.

    PMID: 29234954DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Embryologist Bsc, Msc

Study Record Dates

First Submitted

November 18, 2017

First Posted

November 22, 2017

Study Start

November 1, 2014

Primary Completion

January 1, 2017

Study Completion

June 1, 2017

Last Updated

November 27, 2017

Record last verified: 2017-11