Abstract
BackgroundPoor response to ovarian stimulation with exogenous gonadotrophins occurs in 9–24% of women undergoing in vitro fertilisation (IVF) treatment, which represents an estimated 4000–10,000 women per year in the UK. Poor responders often have their treatment cycle cancelled because of expected poor outcome.One treatment strategy that may influence outcome is the choice of pituitary suppression regimen prior to the initiation of ovarian stimulation. The three commonly used pituitary suppression regimens in IVF treatment are:(1) the GnRH agonist long regimen,(2) the GnRH agonist short regimen and(3) the GnRH antagonist regimen.A systematic review of randomised controlled trials of these pituitary suppression regimens has shown the evidence to be either inconclusive or inconsistent. We therefore designed a three arm randomised trial to evaluate the effectiveness of these regimens in women who had poor ovarian response in a previous IVF treatment cycle.Methods/designConsenting, eligible women will be randomised to one of the three regimens using an internet-based trial management programme that ensures allocation concealment and employs block randomisation and minimisation for prognostic variables. The primary outcome is the number of oocytes retrieved. Other outcomes include total dose of follicle stimulating hormone (FSH) used for ovarian stimulation, mature oocytes retrieved, embryos available for transfer, implantation rate and clinical pregnancy rate.The sample size for this trial has been estimated as 102 participants with 34 participants in each of the three arms. Appropriate interim analysis will be conducted by a Data Monitoring and Ethics Committee (DMEC), and the final analysis will be by intention to treat.Trial registrationISRCTN27044628
Highlights
Poor response to ovarian stimulation with exogenous gonadotrophins occurs in 9–24% of women undergoing in vitro fertilisation (IVF) treatment, which represents an estimated 4000–10,000 women per year in the UK
We designed a three arm randomised trial to evaluate the effectiveness of these regimens in women who had poor ovarian response in a previous IVF treatment cycle
Poor ovarian response, defined as failure of the development of sufficient number of mature follicles to proceed to oocyte retrieval or yielding only a few oocytes following gonadotrophin stimulation in women undergoing in vitro fertilisation (IVF) treatment, occurs in 9–24% of women [1]
Summary
Poor ovarian response, defined as failure of the development of sufficient number of mature follicles to proceed to oocyte retrieval or yielding only a few oocytes following gonadotrophin stimulation in women undergoing in vitro fertilisation (IVF) treatment, occurs in 9–24% of women [1]. Various treatment regimens and interventions have been proposed in an effort to improve ovarian response and IVF outcome in this group of patients. These include different regimens for pituitary suppression, controlled ovarian hyperstimulation (COH) as well as adjuvant therapies [4]. We identified seven randomised controlled trials comparing the regimens with each other.[5,6,7,8,9,10,11] There were no trials that compared all three regimens against each other The quality of these 7 randomised trials was generally poor (only 2/7 trials had adequate allocation concealment reported). A well designed, adequately powered, three arm trial comparing the long GnRH agonist regime versus the short GnRH agonist regime versus the GnRH antagonist regime is needed
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