Table 2

Trial conduct procedures with detailed description and time of assessment

ProcedureDetailed descriptionAssessment
Identification of patientsDirect referral from recruiting doctors within centreFirst consultation
Assessment of eligibilityReview of eligibility criteria
Study explanation
First consultation
Informed consentWritten informed consent from patients to be included in the studyConsultation with study nurses
RandomisationCentral 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
TreatmentPatients will receive allocated treatmentWithin 2 months from randomisation
Follow-up during treatment
Hormonal profile▸ FSH, LH, E2, progesteroneStimulation Days 1, 6, 8 ,10 and day of hCG triggering
Ultrasound scans▸ Assessment of number of growing follicles and endometrial thicknessStimulation Days 6, 8 ,10 and day of hCG triggering
Follow-up after treatment▸ Cycle cancellationStimulation day 8–10
▸ Number of oocytes retrievedDay of oocyte retrieval
▸ Embryo transfer rateDay of embryo transfer
▸ Positive hCG test2 weeks after embryo transfer
▸ Clinical pregnancy Definition: Intrauterine gestational sac at 7 weeks of gestation7 weeks of gestation
▸ Ongoing pregnancy Definition: Intrauterine gestational sac with an embryonic pole demonstrating cardiac activity at 9–10 weeks of gestation9–10 weeks of gestation
  • FSH, follicle-stimulating hormone; hCG, human chorionic gonadotropin; LH, luteinising hormone.