Unexplained infertility Pregnancy and Childbirth
Conditions
Interventions
Couples who enter the trial will be randomised to receive either three cycles of letrozole stimulated Intra Uterine Insemination (IUI) or one cycle of In-Vitro Fertilisation (IVF) with standard ovaria
which aims to assess the standardisation of semen quality assessment at different sites (NB participation in this sub-study is not optional). Additionally, both partners and healthcare providers will
patients taking part in the pilot will follow the pathway described above.
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured using patient records unless otherwise noted: The following outcomes will be assessed at two timepoints: 18 months post-randomisation to allow for pregnancy outcomes to be obtained and concern pregnancies conceived within 240 days (approximately 8 months) of randomisation; and 24 months post-randomisation to allow for pregnancy outcomes to be obtained and concern pregnancies conceived within 420 days (approximately 14 months) of randomisation. Pregnancy outcomes: 1. Singleton live birth =37 weeks 2. TTP leading to a live birth defined as time from randomisation to pregnancy in days (censored at 240 days) 3. Cycle cancellation and reason (failure to respond/over-response) 4. Biochemical pregnancy 5. Clinical pregnancy 6. Ongoing pregnancy at 12 weeks (range 11 to 14 weeks) 7. Multiple pregnancy 8. Ectopic pregnancy 9. Miscarriage (defined as delivery before 24 weeks of gestation) 10. Stillbirth (defined as intrauterine death =24 weeks) 11. Termination 12. Number of embryos remaining (IVF group) Outcomes in live births =24 weeks: 1. Gestational age at delivery 2. Gestation<28 weeks 3. Gestation<32 weeks 4. Gestation<37 weeks 5. Birthweight, grams 6. Small for gestational age (<10th centile) 7. Mode of birth (unassisted vaginal, instrumental vaginal, elective caesarean section, emergency caesarean section) 8. APGAR<7 out of 10 at 1 minute 9. APGAR<7 out of 10 at 5 minutes 10. APGAR<7 out of 10 at 10 minutes 11. Survival at 28 days (or discharge from hospital whichever is sooner) Complications: The following outcomes will be assessed for the first IVF treatment within 420 days post-randomisation. 1. Maternal in IVF only 1.1. Ovarian hyperstimulation syndrome – severe/critical OHSS 1.2. Pelvic infection 1.3. Bleeding post oocyte retrieval 2. Admission to High Dependency Unit (HDU)/ Intensive Therapy Unit (ITU) The following outcomes will be assessed at 28 days post birth (or woman’s discharge date from hospital whichever is sooner). 3. Antenatal 3.1. A | — |
Countries
England, United Kingdom
Contacts
Public ContactKatie Kirkham
Outcome results
None listed