Comparing intrauterine insemination and in vitro fertilisation for unexplained infertility: a study on effectiveness and costs

Not Applicable

• Conditions: nexplained infertility; Pregnancy and Childbirth

• Registration Number: ISRCTN93757751
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-12
• Last Update Posted: 22 July 2024
• Study Completion: 2028-08-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 942

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The live birth of a baby at =34 weeks gestation, conceived within 240 days of randomisation (approximately 8 months). In line with the evaluation of treatment policy, initial or subsequent pregnancies may be included within this timeframe. This outcome will be assessed at 18 months post-randomisation.