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

Study Overview
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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.

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

Conditions
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Clinical Pregnancy Rate

Intervention / Treatment
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* Other: Volume of medium during embryo transfer


Participation Criteria
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Eligibility Criteria
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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 -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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embryo transfer, volume, culture medium, loading the catheter, clinical pregnancy rate