RecruitingOBSERVATIONAL

Biobank Cycle Collection

This study is collecting daily urine samples from women in the UK who are trying to get pregnant. The goal is to build a large collection (biobank) of these samples. This collection will include samples from cycles where pregnancy happens and from cycles where it doesn't, along with information about your menstrual cycle and pregnancy test results. This helps researchers understand more about fertility and early pregnancy. If you take part, you'll receive a Clearblue Ovulation product to help you pinpoint your most fertile days. You'll collect urine samples first thing each morning and keep a simple diary for up to three months, or until you confirm pregnancy.

At a glance

Status

Recruiting

Sponsor

SPD Development Company Limited

Enrolment target

1,500

Start

06 Dec 2022

Estimated completion

01 Jan 2028

Pregnancy

What is this study about?

This study is about building a special collection (called a biobank) of urine samples from women who are trying to start a family. Think of it like a library of very important information that researchers can use in the future. The project aims to collect samples from menstrual cycles where a woman becomes pregnant, as well as from cycles where she doesn't. This helps scientists to understand the differences and learn more about fertility and the very early stages of pregnancy.

When you take part, you'll be given a Clearblue Ovulation product. This is a common product that helps you identify your most fertile days, which might help you conceive. The main part of your participation involves collecting a urine sample yourself each morning. You'll also keep a simple diary of your period dates and pregnancy test results. This information, along with the urine samples, will help researchers understand important hormone changes related to fertility and pregnancy.

The samples you provide will be carefully stored at a very cold temperature. Researchers will use these samples to look at different hormones linked to fertility and pregnancy. This information is vital for developing new and improved products related to fertility and early pregnancy in the future, ultimately benefiting many women.

Key takeaways

Your contribution helps research into fertility and early pregnancy.
You'll collect daily urine samples at home.
You'll use a Clearblue Ovulation product.
Participation lasts up to 3 months, or until early pregnancy is confirmed.
No clinic visits or medication are involved.

Who may be eligible?

To be able to join this study, you need to be a woman aged 18 or over and actively trying to conceive a baby. It's important that you've had at least two regular periods in a row since your last pregnancy, miscarriage, or since you stopped breastfeeding or using contraception. You must be willing to share your pregnancy results and provide urine samples, and you need to be happy to give your informed consent and follow the study's simple steps.

There are also some reasons why you might not be able to join. For instance, if you've been trying to conceive for more than 6 months (if you're under 35) or more than 3 months (if you're 35 or over). You also can't take part if you've been diagnosed with Polycystic Ovary Syndrome (PCOS), or if you're already pregnant, breastfeeding, or taking medication that affects your menstrual cycle, like the contraceptive pill. If you're using or have recently used fertility treatments (like IVF, ovulation drugs, or certain hormone medications), or if you're experiencing symptoms of menopause, this study won't be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged 18 or over?
Are you actively trying to get pregnant?
Have you had at least two regular periods since your last pregnancy, miscarriage, or stopping contraception/breastfeeding?
Are you willing to provide daily urine samples and keep a diary?
Have you been trying to conceive for less than 6 months (if under 35) or less than 3 months (if 35 or over)?
Are you NOT pregnant, breastfeeding, or using fertility treatments or certain hormone medications?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first read and sign an informed consent form to make sure you understand everything. You'll then receive a Clearblue Ovulation product to help you track your cycle. Your main task will be to collect a small amount of urine first thing every morning. You'll continue this until you confirm you're pregnant, or until your next period starts. You'll also keep a simple diary noting your period dates, when you collected samples, and the results of any pregnancy tests you do.

This process will continue for up to three menstrual cycles if you don't become pregnant. If you do become pregnant during the study, you'll continue collecting samples until about day 60 of your pregnancy. There are no clinic visits required; all sample collection and diary keeping happen conveniently at home. The total duration of your participation will be a maximum of three months if you don't conceive, or up to about two months if you do.

Potential risks and benefits

Taking part in this study offers the benefit of receiving a Clearblue Ovulation product free of charge, which can help you understand your fertility. More broadly, your contribution will help researchers understand fertility and pregnancy better, potentially leading to new developments in women's health. The risks are very minimal; they mainly involve the time commitment for daily urine collection and diary keeping. There's no medication involved, and you can withdraw from the study at any time without giving a reason, and it won't affect any medical care you receive.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

SPD Development Company Ltd
Verified postcode
Bedford, United Kingdom· Recruiting

Common questions

What will I have to do if I join the study?

You'll collect daily morning urine samples and keep a simple diary of your periods and pregnancy test results. You'll also use a Clearblue Ovulation test.

How long will I be in the study?

You'll participate for up to three menstrual cycles, or until approximately day 60 if you become pregnant.

Do I need to go to a clinic?

No, all activities like collecting samples and keeping a diary are done at home.

Will I get any medication?

No, this study does not involve any medication. You'll receive a Clearblue Ovulation product to help track your cycle.

What happens to my samples?

Your urine samples will be stored at a very cold temperature and used by researchers to study hormones related to fertility and pregnancy, helping with future product development.

How to find out more

Sarah Weddell

sarah.weddell@spdspark.com 01234 835000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.