WithdrawnNot Applicable

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

Stopped: Sponsor stopped the study due to poor enrollment

Spain0Started 2017-06-15

Plain-language 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.

Who can participate

Age range18 Years – 43 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Fertilization rate

Timeframe: 1 day

Trial details

NCT IDNCT03191890

SponsorAnecova SA

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-03-31

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