VB003
Research type
Research Study
Full title
Study to investigate intra-uterine temperature and intra-uterine oxygen levels, and the impact of sildenafil
IRAS ID
319521
Contact name
Andrea Goodyer
Contact email
Sponsor organisation
Verso Biosense
Duration of Study in the UK
0 years, 6 months, 29 days
Research summary
Many couples suffering from subfertility cannot be provided with a diagnosis. The success of assisted conception remains low (30% live births per cycle of treatment). Currently, therapeutic strategies aimed at improving implantation are not guided by diagnostic information about the intra-uterine environment
IVF technologies have highlighted the exquisite sensitivity of the pre-implantation embryo to its environment, in particular to dissolved oxygen (DO), temperature and pH. Any deviation in these parameters can affect the development of the egg, embryo, implantation and the growth of a pregnancy. By monitoring these bio-physical factors, deviations from what is optimal can be identified and potentially treated.
A previous study demonstrated this device is well tolerated and safe to use for seven days in women, and produces reliable data. This follow-on study aims to collect continuous data on the temperature and dissolved oxygen in the uterine cavity over the seven days of the menstrual cycle during which implantation of an embryo in a human uterus normally occurs and to determine the impact on these parameters of administering a vasodilator, Sildenafil.
The study will be carried out on 30 healthy women who have normal menstrual cycles, to investigate whether these parameters can be altered by increasing endometrial blood flow, participants will self administer vaginal sildenafil 100mg once per day starting 3 days after insertion of the device.
There are no anticipated immediate clinical benefits to the participants in the study.REC name
London - Fulham Research Ethics Committee
REC reference
23/LO/0283
Date of REC Opinion
23 Nov 2023
REC opinion
Further Information Favourable Opinion