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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02214537
Other study ID # MADDA12201301
Secondary ID
Status Terminated
Phase N/A
First received July 25, 2014
Last updated April 3, 2018
Start date February 2016
Est. completion date February 2018

Study information

Verified date April 2018
Source IVI Madrid
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The embryokinetics may be a new prognostic factor for choosing the human embryos with the highest implantation potential. In order to identify the factors that may affect the rate of embryo cleavage, there are many studies about morphokinetics and culture medium, oxygen tension, oocyte quality or type of medication used for ovarian stimulation. However there are no published data with respect to the influence of sperm DNA fragmentation in the embryo kinetic.


Recruitment information / eligibility

Status Terminated
Enrollment 60
Est. completion date February 2018
Est. primary completion date February 2018
Accepts healthy volunteers No
Gender All
Age group 36 Years to 38 Years
Eligibility Inclusion Criteria:

- Patients 36 to 38 years

- Fresh sample semen

- Minimum 6 oocytes

- Semen sample with at least 5 million/ml and at least 30% of progressive motile sperm.

Exclusion Criteria:

- Patients younger than 36 or older than 38 years old

- Frozen semen sample

- Less tan 6 oocytes.

- Semen samples with less than 5 million / ml or less than 30% of motile sperm.

Study Design


Intervention

Other:
MACS


Locations

Country Name City State
Spain IVI Madrid Madrid

Sponsors (1)

Lead Sponsor Collaborator
IVI Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time of pronuclear appearance in hours. We want to study whether differences exist in the time of appearance of pronuclei in those embryos that derived from semen samples from the two study groups
the minimum value of the difference to be detected; we said that about 3 hours apart.
The mean time of appearance of pronuclei is 3.3951 hours in our patients. We are going to evaluate pronuclear appearence time in hours in our study groups