Validation of Inito Fertility Monitor with respect to laboratory measures of fertility related hormones

Inito0 个研究点目标入组 177 人开始时间: 2020年12月17日最近更新: 2023年6月20日

适应症

试验速览

2021 Preprint results in https://doi.org/10.1101/2021.05.11.21257023 (added 14/03/2022) 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/36654688/ Results from a technology verification cohort of blood samples collected from 20 new users of the Inito Fertility Monitor following the same protocol as the primary cohort (added 23/01/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37286704/ (added 08/06/2023)

•1. Women aged between 21 and 45 years
•2. Menstruation cycle length of 21 to 42 days
•3. Willing to provide written informed consent to participate in the study and comply with the investigational procedures

•1. Have a condition that is known to be contra-indicated in pregnancy
•2. Using or have used in their last 2 cycles, hormonal contraceptives, including oral, emergency oral, implants, patches, transdermal injections, vaginal ring, or progesterone intrauterine systems (IUS)
•3. Using or have used in the last 2 cycles, infertility medications or hormone replacement therapy containing luteinizing hormone (LH) or human chorionic gonadotropin (hCG)
•4. Taking clomiphene citrate or other ovulation induction drugs
•5. Are using any treatment which may affect the menstrual cycle
•6. Have recently been pregnant, miscarried, or breastfeeding
•7. Have been diagnosed with polycystic ovarian syndrome (PCOS)

发起方

Inito