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

NCT ID: NCT03350646

Last Updated: 2017-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

236 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-06-30

Brief Summary

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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)

Detailed Description

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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.

Conditions

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Clinical Pregnancy Rate

Keywords

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embryo transfer volume culture medium loading the catheter clinical pregnancy rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Low volume (20-25 μl)

Low volume (20-25 μl)

Group Type OTHER

Volume of medium during embryo transfer

Intervention Type OTHER

High volume (40-45 μl)

High volume (40-45 μl)

Group Type OTHER

Volume of medium during embryo transfer

Intervention Type OTHER

Interventions

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Volume of medium during embryo transfer

Intervention Type OTHER

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Aretaieion University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Georgios Sigalos

Embryologist Bsc, Msc

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 29234954 (View on PubMed)

Other Identifiers

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B-74/30-10-2014

Identifier Type: -

Identifier Source: org_study_id