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

Clinical Pregnancy Rate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03350646
• Other study ID #: B-74/30-10-2014
• Status: Completed
• Phase: N/A
• First received: November 18, 2017
• Last updated: November 22, 2017
• Start date: November 2014
• Est. completion date: June 2017

Study information

• Verified date: November 2017
• Source: Aretaieion University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: June 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Clinical Pregnancy Rate

Intervention

Other:
• Volume of medium during embryo transfer

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Aretaieion University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate	Number of clinical pregnancies expressed per 100 embryo transfer cycles	25 days after embryo transfer
Secondary	Implantation rate	The number of gestational sacs observed divided by the number of embryos transferred.	25 days after embryo transfer
Secondary	Ongoing pregnancy rate	Number of pregnancies till 20 weeks of gestation expressed per 100 embryo transfer cycles	20 weeks