Trial conduct procedures with detailed description and time of assessment
| Procedure | Detailed description | Assessment |
|---|---|---|
| Identification of patients | Direct referral from recruiting doctors within centre | First consultation |
| Assessment of eligibility | Review of eligibility criteria Study explanation | First consultation |
| Informed consent | Written informed consent from patients to be included in the study | Consultation with study nurses |
| Randomisation | Central randomisation by study nurses in the co-ordinating centre a. Patients from co-ordinating centre will be directed to study nurses where they will be allocated to treatment of control group following the selection of sealed-opaque sequentially numbered envelopes b. Patients from the other recruiting centres will be allocated to treatment and control groups following telephone contact with the co-ordinating centre from the recruiting physicians with the study nurse of the co-ordinating centre. | Consultation with study nurses |
| Treatment | Patients will receive allocated treatment | Within 2 months from randomisation |
| Follow-up during treatment | ||
| Hormonal profile | ▸ FSH, LH, E2, progesterone | Stimulation Days 1, 6, 8 ,10 and day of hCG triggering |
| Ultrasound scans | ▸ Assessment of number of growing follicles and endometrial thickness | Stimulation Days 6, 8 ,10 and day of hCG triggering |
| Follow-up after treatment | ▸ Cycle cancellation | Stimulation day 8–10 |
| ▸ Number of oocytes retrieved | Day of oocyte retrieval | |
| ▸ Embryo transfer rate | Day of embryo transfer | |
| ▸ Positive hCG test | 2 weeks after embryo transfer | |
| ▸ Clinical pregnancy Definition: Intrauterine gestational sac at 7 weeks of gestation | 7 weeks of gestation | |
| ▸ Ongoing pregnancy Definition: Intrauterine gestational sac with an embryonic pole demonstrating cardiac activity at 9–10 weeks of gestation | 9–10 weeks of gestation |
FSH, follicle-stimulating hormone; hCG, human chorionic gonadotropin; LH, luteinising hormone.