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Duration of luteal support (DOLS) with progesterone pessaries to improve the success rates in assisted conception: study protocol for a randomized controlled trial
Authors:Rafet Gazvani  Yasmin Sajjad  Richard Russell  Zarko Alfirevic
Abstract:ABSTRACT: BACKGROUND: Luteal phase support has been shown by a meta analysis of prospective randomised studies, to be beneficial in establishing a pregnancy after IVF. The optimal length of treatment is unresolved at present and it remains unclear how long to treat women receiving luteal supplementation. It has been used for as little as 2 weeks and for as long as 12 weeks of gestation. OBJECTIVE: To conduct a prospective randomised double blind study to investigate the effect of the duration of luteal support with progesterone in IVF cycles. Trial design: Following 2 weeks of standard treatment and a positive biochemical pregnancy test, this randomised control trial will allocate women to a supplementary 8 weeks of treatment of vaginal progesterone or 8 weeks of placebo. Eligibility: All women presenting to the Hewitt Centre for Reproductive Medicine, Liverpool Women's NHS Foundation Trust, for assisted conception with a positive biochemical pregnancy test at 2 weeks post embryo transfer are eligible to enter the trial. Primary outcome measure:The primary outcome measure is the proportion of all randomised women that continue successfully to a viable pregnancy (at least one fetus with FHR >100 beats minute) on transabdominal / transvaginal ultrasound at 10 weeks post embryo transfer / 12 weeks gestation (i.e. at the end of 8 weeks supplementary trial treatment).
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