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

Not Applicable

Completed

• Conditions: Clinical Pregnancy Rate
• Interventions: Other: Volume of medium during embryo transfer

• Registration Number: NCT03350646
• Lead Sponsor: Aretaieion University Hospital

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)

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 Timeline

• Study Start: 2014-11
• Primary Completion: 2017-01
• Study Completion: 2017-06
• Status Verified: 2017-11
• Study First Submitted: 2017-11-18
• Study First Submitted QC: 2017-11-18
• Study First Posted: 2017-11-22
• Last Update Submitted: 2017-11-22
• Last Update Posted: 2017-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 236

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High volume (40-45 μl)	Volume of medium during embryo transfer	High volume (40-45 μl)
Low volume (20-25 μl)	Volume of medium during embryo transfer	Low volume (20-25 μl)

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	25 days after embryo transfer	Number of clinical pregnancies expressed per 100 embryo transfer cycles

Secondary Outcome Measures

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