A randomised controlled trial evaluating the clinical and cost-effectiveness of intrauterine insemination (IUI) versus in vitro fertilisation (IVF) for unexplained infertility

niversity of Birmingham0 个研究点目标入组 942 人开始时间: 2024年1月12日最近更新: 2024年7月22日

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•Couples with a diagnosis of unexplained infertility, referred to fertility centres for assisted conception, will be considered for the UNiTY trial.
•Unexplained fertility for the purpose of this trial is defined as the absence of the following fertility explanations after complete investigations:
•1. Female infertility
•1.1. Tubal disease
•1.2. Deep endometriosis +/- ovarian endometriosis
•1.3. Significant uterine abnormality requiring surgery (including cavity distorting fibroids, fibroids >5 cm or multiple fibroids)
•1.4. Uterine septum with history of previous pregnancy loss
•2. Male infertility
•2.1. Total progressively motile sperm count less than 10M
•2.2. Normal sperm morphology of 2% or less

•1. Female partner is 39 years or older on the date of randomisation
•2. Either partner is under 18 years old
•3. Female partner's BMI is <19.0 or >34.9 kg/m²
•4. Either or both partners have a diagnosis of an ongoing sexually transmitted infection
•5. If self-funded, couple unable to pay for IVF
•6. Either partner is unable to give informed consent
•7. Either partner is unable to complete trial follow-up
•8. 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.

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