Does the Volume of the Embryo Culture Medium During Embryo Transfer Affects the IVF Outcomes?

November 22, 2017 updated by: Georgios Sigalos, Aretaieion University Hospital

Low Versus High Volume of Culture Medium During Embryo Transfer: a Randomized Clinical Trial.

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The volume of culture medium used for embryo transfer is a variable that has been speculated to affect the IVF outcome. It is known that ultra high volume (>100 μl) of medium during embryo transfer may result in embryo expulsion out of the uterus or ectopic pregnancy. Similarly, some authors advocate that ultra low volume of transferring medium (<10 μl) may negatively affect pregnancy and implantation rates.

However small differences in the volume of the culture medium may favor the outcome of the embryo transfer. The aim of this study was to evaluate if the use higher volume (40-45μl VS 20-25 μl) of media used for embryo transfer affects the clinical outcomes in fresh IVF cycles.

Study Type

Interventional

Enrollment (Actual)

236

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. PGD cycles
  2. Frozen -thaw cycles

  3. Natural cycles or patients following different ovarian stimulation protocol were excluded from the study

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Low volume (20-25 μl)
Other: Volume of medium during embryo transfer
Other: High volume (40-45 μl)
Other: Volume of medium during embryo transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 25 days after embryo transfer
Number of clinical pregnancies expressed per 100 embryo transfer cycles
25 days after embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implantation rate
Time Frame: 25 days after embryo transfer
The number of gestational sacs observed divided by the number of embryos transferred.
25 days after embryo transfer
Ongoing pregnancy rate
Time Frame: 20 weeks
Number of pregnancies till 20 weeks of gestation expressed per 100 embryo transfer cycles
20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aretaieion University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

November 18, 2017

First Submitted That Met QC Criteria

November 18, 2017

First Posted (Actual)

November 22, 2017

Study Record Updates

Last Update Posted (Actual)

November 27, 2017

Last Update Submitted That Met QC Criteria

November 22, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • B-74/30-10-2014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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