Abstract
BackgroundApproximately 15% of couples in the reproductive age are affected by infertility. Women with diminished ovarian reserves (DOR) or with a poor ovarian response (POR) are required to undergo in vitro fertilization and embryo transfer (IVF-ET) to achieve pregnancy. However, studies indicate that poor response to gonadotropin stimulation has been reported in women undergoing IVF-ET. Results from two recent clinical studies in China suggest that traditional Chinese medicine (TCM) formula Dingkun pill (DKP) showed a curative effect by improving the clinical pregnancy rate in women with DOR and POR. However, the heterogeneity of the studies does not allow one to draw a definitive conclusion on the therapeutic effect of DKP. Therefore, the purpose of this study was to investigate the effect of DKP on improving the clinical outcome of pregnancy of IVF-ET in women with low prognosis.MethodsA multicenter, double-blinded, randomized placebo-controlled trial was conducted. A total of 460 infertile patients undergoing IVF or intracytoplasmic sperm injection (ICSI) were recruited from 12 public hospitals in China. Participants were randomly divided into the experimental group (DKP formula) or the placebo group (control) at a ratio of 1:1. All patients were treated with GnRH antagonist protocol and ovarian stimulation performed for 5 weeks (from the 5th day of the previous menstrual cycle to the day of oocyte retrieval). The patients were followed up for 6 months to record their conception outcome. The primary outcome is to compare the pregnancy outcome to those under placebo treatment. Secondary outcomes included the total count of the retrieved oocyte, embryo quality, endometrial thickness on ET day, implantation rate, and early miscarriage rate.DiscussionCurrently, no multicenter, double-blind, randomized, placebo-controlled trials have been performed on the use of the DKP formula to improve on the clinical outcome of the conception of IVF-ET in women with low prognosis. DKP might provide a good clinical solution for females with low prognosis and undergoing IVF. There is no contemporary Western medicine to improve on the clinical outcome of conception in IVF-ET in women with low prognosis. Therefore, it is important to undertake a well-designed randomized trial to determine the effect of DKP in improving the clinical outcome of the conception of IVF-ET in women with low prognosis.Trial registrationChinese Clinical Trial Registry (ChiCTR). Trial registration number: ChiCTR1900026614. Registered on 16 October 2019.
Highlights
15% of couples in the reproductive age are affected by infertility
Currently, no multicenter, double-blind, randomized, placebo-controlled trials have been performed on the use of the Dingkun pill (DKP) formula to improve on the clinical outcome of the conception of in vitro fertilization and embryo transfer (IVF-ET) in women with low prognosis
There is no contemporary Western medicine to improve on the clinical outcome of conception in IVF-ET in women with low prognosis
Summary
15% of couples in the reproductive age are affected by infertility. Women with diminished ovarian reserves (DOR) or with a poor ovarian response (POR) are required to undergo in vitro fertilization and embryo transfer (IVF-ET) to achieve pregnancy. Postponing childbearing due to socio-economic reasons has shown an increasing trend worldwide The consequences of this are an increased number of women having a poor ovarian response (POR) prior to IVF due to their old age. Even though IVF-ET has become an effective and widely available treatment for infertile couples, women with DOR or POR to exogenous gonadotropin stimulation present a challenge to reproductive experts [4]. There are a number of associated disadvantages such as fewer oocyte yield, poorer embryo quality, and pregnancy outcome [8] These factors cause emotional, physical, and financial burden and distress for the couple, especially when multiple treatment cycles are required [9]. Regardless of the various pre-treatment strategies available including coenzyme Q10 [10] and dehydroepiandrosterone (DHEA) [11], there is a lack of sufficient evidence on the ability of these therapeutic agents to reverse low prognosis especially in women of advanced age and with DOR [12]
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