Post Market Surveillance & Post Market Clinical Follow up, International, Medical Registry to Confirm the Safety and the Performance of the Anecova Intra Uterine Culture Device

Infertility Clinical Trial

Official title:

Observational, Non-Interventional, Prospective, Post Market Surveillance & Post Market Clinical Follow up, International, Medical Registry to Confirm the Safety and the Performance of the Anecova Intra Uterine Culture Device for Participants With Subfertility Issue Undergoing Assisted Reproductive Medical Treatment in Routine Clinical Practice

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03191890
• Other study ID #: NCV_REG_01
• Status: Withdrawn
• Start date: June 15, 2017
• Est. completion date: March 31, 2018

Study information

• Verified date: April 2019
• Source: Anecova SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study is designed to generate a comprehensive survey of the use on the market of the Anecova device within its intended indications according to the Instructions For Use. The Anecova Registry is part of the Anecova quality system, to enable the Post Marketing Surveillance and the Post Market Clinical Follow-up.

Description:

As soon as the very first minute of the fertilization process, very important biological events, critical for the future developmental competency of the embryo are taking place.

These biological events, after the sperm cell entry in the oocyte cytoplasm and prior to the first cleavage, include: the completion of the meiosis, the exclusion of the second polar body, the pronuclei formation, the replication of the male and female DNA and the chromosome segregation on the newly formed mitotic spindle.

If any of these events is aberrant, one or both of the two daughter cells and their descendants may carry chromosomal anomalies. In other words an uneven first cleavage in size or in content is associated with chromosomal abnormality and aneuploidy.

In vivo all these events occur in a natural environment where the presence of specific molecules and of a dynamic and physiological environment might be an advantage over in vitro culture conditions to ensure optimal cellular functions.

The Registry will capture information from the Anecova procedure, from the outcomes, from the procedure performance, from the safety and from the utilization of the Anecova Medical Device in clinical routine.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 31, 2018
• Est. primary completion date: March 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 43 Years

Eligibility

Inclusion Criteria:

• Age between 18 and 43,

• Hormonal serum levels within normal ranges for the routinely or specifically tested hormones (FSH, LH, AMH, E2, PRL, P4, TSH),

• BMI between 18 and 29, If assessed normal antral follicular count and regular menses

Exclusion Criteria:

• Endometrial, autoimmune or hormonal specificities, as well as presence of pathology that could be potentially deleterious to the healthy development of embryos in the uterine cavity (i.e. severe endometriosis),

• Acute or chronic gynecological infection

Related Conditions & MeSH terms

• Infertility
• Reproductive Sterility

Locations

Country	Name	City	State
Spain	IVI Bilbao	Leioa	Euskadi

Sponsors (1)

Lead Sponsor	Collaborator
Anecova SA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fertilization rate	Number of zygotes over all transferred injected/inseminated oocytes	1 day
Secondary	Biochemical Pregnancy rate	hCG test	15 days
Secondary	Implantation rate	number of gestational sac per transferred embryos	5 weeks
Secondary	Clinical pregnancy rate	beating heart	9 weeks