VB002 Version 1
Research type
Research Study
Full title
Study to investigate intra-uterine temperature and intra-uterine oxygen levels in females with normal menstrual cycles
IRAS ID
316600
Contact name
Roy Homburg
Contact email
Duration of Study in the UK
0 years, 8 months, 31 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 \nIVF 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. \nA 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.\nThe study will be carried out on 30 healthy female volunteers with normal menstrual cycles\nThere are no anticipated immediate clinical benefits to the participants in the study.\n \n
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
23/WM/0012
Date of REC Opinion
23 Feb 2023
REC opinion
Further Information Favourable Opinion