Triptorelin Oral contraceptive Pill Flare-up in IVF/ICSI Treatment trial.

N/A

26-Apr-2013: Trial has ended prematurely due to a inclusion shortage.

The aim of the study is to show non-inferiority of a short, flare-up GnRH-agonist protocol to the GnRH-antagonist protocol, both with OC pill pre-treatment, in women undergoing in vitro fertilisation (IVF) or intracellular sperm injection (ICSI) treatment with gonadotrophins.

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 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.

1. Flare-up GnRH-agonist protocol with OC pill pre-treatment. OC pill is given during 21±3 days of the preceding cycle. On day two of the menses after withdrawal of the OC pill of the following cycle, triptorelin is started, accompanied at day three by HP-hMG in a fixed dose of 150 IU. Both are given until criteria for hCG administration are met;

2. GnRH-antagonist protocol with OC pill pre-treatment. OC pill is given during 21±3 days of the preceding cycle. On day three of the menses of the following cycle, HP-hMG (fixed dose of 150 IU) is started and accompanied by cetrorelix at day six of gonadotrophin administration, both given until criteria for hCG administration are met.