Female infertility Urological and Genital Diseases Female infertility
Conditions
Interventions
Urine samples were collected by each participant at home every day for the duration of one menstrual cycle. The samples were frozen by putting the samples in the cold box container provided and sent t
Sponsors
Inito
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Device readings of luteinizing hormone (LH), estradiol glucuronide (E3G), and pregnanediol glucuronide (PdG) measured using the Inito Fertility Monitor, Clearblue Fertility Monitor, and ELISA with urine samples collected daily for the course of 1 menstrual cycle | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. User feedback on the sufficiency of data measured using a questionnaire at the end of 1 menstrual cycle 2. Lifestyle or infertility related conditions measured using an onboarding questionnaire at baseline | — |
Countries
India
Contacts
Public ContactSiddharth Pattnaik
Outcome results
None listed