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Completed

NCT Number: NCT03350646

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

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)

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Key information

Conditions

Clinical Pregnancy Rate

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 -

Exclusion criteria

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

-

Treatment and study plan

Volume of medium during embryo transfer

Other

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: 25 days after embryo transfer

    Number of clinical pregnancies expressed per 100 embryo transfer cycles

Secondary outcomes

  1. Implantation rate

    Time frame: 25 days after embryo transfer

    The number of gestational sacs observed divided by the number of embryos transferred.

  2. Ongoing pregnancy rate

    Time frame: 20 weeks

    Number of pregnancies till 20 weeks of gestation expressed per 100 embryo transfer cycles

Sponsors and collaborators

Lead sponsor

Aretaieion University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 22, 2017
Registry last updated
Nov 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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