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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Mrs
Katie
Kirkham
+44 (0)121 415 9109
k.l.kirkham@bham.ac.uk
Prof
Jackson
Kirkman-Brown
+44 121 627 2739
j.kirkmanbrown@bham.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Unexplained infertility
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Unexplained infertility affects a significant number of couples, causing emotional distress and leading them to consider costly and intensive treatments like in vitro fertilization (IVF). IVF involves hormone injections to stimulate egg production, followed by egg retrieval, fertilization in a lab, and embryo transfer. However, IVF carries risks such as infection and ovarian hyperstimulation syndrome. Intrauterine insemination (IUI), a simpler procedure with lower hormone doses, directly introduces sperm into the womb to increase the chances of fertilization.
Current UK guidelines recommend IVF for unexplained infertility, but recent research suggests that three cycles of IUI may offer similar success rates and be more cost-effective. To investigate this further, a randomized controlled trial is planned, where couples will be randomly assigned to receive either three cycles of IUI or proceed directly to an IVF cycle. Couples assigned to IUI can still opt for IVF if unsuccessful. The study will assess patient outcomes such as quality of life, work disruption, and emotional/physical burden, alongside evaluating cost-effectiveness.
The research has been developed in collaboration with fertility patient treatment co-design groups, commissioners, and laypeople. Patient voices have been incorporated through questionnaires, focus groups, and the involvement of a patient co-applicant and infertility counselor. The study aims to recruit a diverse patient population and intends to share the results with healthcare professionals, policymakers, patient support groups, and the general public through various channels, including medical journals, scientific meetings, and accessible online resources.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Female partner is 39 years or older on the date of randomisation2. Either partner is under 18 years old3. Female partner's BMI is <19.0 or >34.9 kg/m²4. Either or both partners have a diagnosis of an ongoing sexually transmitted infection5. If self-funded, couple unable to pay for IVF6. Either partner is unable to give informed consent7. Either partner is unable to complete trial follow-up8. Couple has had two or more consecutive IVF treatment failures
If couples do not meet the requirements for NHS-funded IVF in their area, but do meet the trial eligibility criteria, they can proceed as self-funded participants.
The female age limit for NHS-funded IVF treatment is 40 years. In order for couples to have multiple cycles of IUI followed by IVF before turning 40 years of age, and without jeopardising their funding, women will need to be <39 years of age on the date of randomisation. Research teams will discuss this with all couples during screening, particularly those in which the woman is older, to be sure they understand the possibility of losing NHS funding.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Jackson
Kirkman-Brown
+44 121 627 2739
j.kirkmanbrown@bham.ac.uk
Mrs
Katie
Kirkham
+44 (0)121 415 9109
k.l.kirkham@bham.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Birmingham and funded by Health Technology Assessment Programme.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 60300
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
