Intrauterine Embryo Development With ANECOVA Device

Instituto Valenciano de Infertilidad, IVI VALENCIA

Status and phase: Terminated; Phase 3

Conditions: Healthy

Treatments: Device: in vivo (ANECOVA D-1) or in vitro culture in 25-µl droplets of cleavage medium (Medicult®) under paraffin oil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00480103

NCVD1H

Details and patient eligibility

About

We aim to compare the morphological and chromosomal features of human embryos cultured In Vitro versus those developed in a new In Vivo culture system with encapsulation in utero as well as implantation and pregnancy rate.

Sex: All

Ages: 18 to 36 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women age below 37
• Hormonal serum levels within normal ranges (FSH, LH, E2, PRL, P4, T4, TSH)
• Negative serologic screening for HIV, Hep B and C
• No uterine or ovarian alterations found by ultrasound
• Normal BMI (19 - 29 kg/m2).

Exclusion criteria

• At least 8 stage MII oocytes are not retrieved
• Endometriosis or PCO
• Severe male factor in the partner

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)