Study Stopped
Sponsor stopped the study due to poor enrollment
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
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
1 other identifier
observational
N/A
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2017
CompletedFirst Submitted
Initial submission to the registry
June 16, 2017
CompletedFirst Posted
Study publicly available on registry
June 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2018
CompletedApril 4, 2019
April 1, 2019
10 months
June 16, 2017
April 3, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fertilization rate
Number of zygotes over all transferred injected/inseminated oocytes
1 day
Secondary Outcomes (3)
Biochemical Pregnancy rate
15 days
Implantation rate
5 weeks
Clinical pregnancy rate
9 weeks
Eligibility Criteria
Participants following a normal course of in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) can benefit from the use of the Anecova device
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Anecova SAlead
Study Sites (1)
IVI Bilbao
Leioa, Basque Country, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 9 Weeks
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2017
First Posted
June 19, 2017
Study Start
June 15, 2017
Primary Completion
March 31, 2018
Study Completion
March 31, 2018
Last Updated
April 4, 2019
Record last verified: 2019-04