infertility IVF/ICSI treatment
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - IVF or ICSI treatment (first, second or third cycle) - Signed informed consent
Exclusion criteria
Exclusion criteria: - Women aged over 39 years - Women with a single ovary - Known poor responders, defined as women with a follicle count of 14 mm in a previous IVF/ICSI treatment cycle - History or evidence of polycystic ovary syndrome (PCOS) or incipient ovarian failure (IOF) - Severe endometriosis, stage III/IV, needing Surrey stimulation protocol - Women with known contraindications for oral OCs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the incidence of premature LH surges, defined as a serum LH value > 10 IU/l, with or without a rise in progesterone, defined as a value > 1 ng/ml (> 3.18 nmol/l). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include incidence of premature urine LH surges, follicular development, number of oocytes and (top-quality) embryo*s, embryo metabolomics, endometrial thickness, hormone levels (LH, FSH, oestradiol, progesterone), (signs of) ovarian hyperstimulation syndrome (OHSS), cancellation rate, fertilisation rate, implantation rate, ongoing pregnancy rate and live birth rate. In addition, (hypo-oestrogenic) adverse events and total dose and duration of GnRH analogue and gonadotrophin treatment will be assessed. | — |
Countries
Netherlands