Biobank Cycle Collection

Launched by SPD DEVELOPMENT COMPANY LIMITED · Nov 30, 2022

Keywords

ClinConnect Summary

This clinical trial, called the Biobank Cycle Collection, is looking at how daily urine samples from women trying to get pregnant can help create a collection of biological samples, known as a biobank. Women who take part will receive a special ovulation test from Clearblue to help them identify their most fertile days, which can increase their chances of conceiving. Participants will provide early morning urine samples every day for up to three menstrual cycles and keep a diary of their menstrual periods and pregnancy tests.

To join the study, women need to be at least 18 years old and actively trying to conceive, having had at least two regular menstrual cycles since their last pregnancy, miscarriage, or stopping birth control. They should be willing to share their pregnancy status and provide urine samples. However, women who have been trying to conceive for more than six months (if under 35) or more than three months (if 35 or older), have certain medical conditions like Polycystic Ovary Syndrome (PCOS), or are currently pregnant or breastfeeding cannot participate. This study aims to better understand fertility and help future research, and all samples will be stored securely for later use.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Females aged 18 and over actively trying to conceive
• • At least 2 regular consecutive cycles since last pregnancy/miscarriage/ stopping breastfeeding or contraception
• • Willing to disclose their pregnancy status and provide urine samples.
• • Willing to give informed consent and comply with the study procedures
• Exclusion Criteria:
• • Trying to conceive for \>6 months (under 35 years) or \> 3 months (35 years and over)
• • Has a diagnosis of Polycystic Ovary Syndrome (PCOS)
• • Taking medication or has known condition which means they should not get pregnant.
• • Currently pregnant or breastfeeding
• • Using any treatment which may affect the menstrual cycle (e.g. contraceptive pill)
• • Using or has previously used infertility medications or hormone replacement medications containing LH or hCG \\ (e.g. Pregnyl®)
• • Using or undergoing any other medical treatment for fertility such as ovulation drugs, artificial insemination and assisted fertility such as IVF or ICSI
• • Peri-or post-menopausal, e.g. experiencing symptoms: irregular menstrual periods, hot flushes, night sweats, sleep disturbances and/or moods swings
• • Abnormal liver or kidney function
• • Taking antibiotics containing tetracycline.
• • Participated in this study within the last 6 months

Trial Officials