Article ; Online: Efficacy and safety of Ding-Kun-Dan for female infertility patients with predicted poor ovarian response undergoing in vitro fertilization/intracytoplasmic sperm injection: study protocol for a randomized controlled trial.
2018 Volume 19, Issue 1, Page(s) 124
Abstract: ... of Ding-Kun-Dan (DKD) pre-treatment.: Methods/design: This study is a multicenter, randomized ...
| Abstract | Background: Women undergoing in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) who have a predicted poor ovarian response (POR) present a challenge for reproductive medicine specialists. Traditional Chinese medicine (TCM) is commonly used in China for such patients, in the belief that it will improve the ovarian response and ultimately increase pregnancy rates. However, there is a lack of high-quality evidence about the effect of TCM on improving ovarian response in such patients. The purpose of this study is to evaluate ongoing viable pregnancy rate at 12 weeks' gestation and related indicators of ovarian response in fertile women who have a predicted poor ovarian response having immediate versus delayed IVF/ICSI after 3 months of Ding-Kun-Dan (DKD) pre-treatment. Methods/design: This study is a multicenter, randomized controlled, parallel-group, phase III, superiority clinical trial. Two hundred and seventy-eight eligible female infertility patients with POR will be included in the study and randomly allocated into an immediate treatment group and a DKD group in a 1:1 ratio. Both groups will receive IVF or ICSI as a standard treatment while in the DKD group, a commercially available Chinese medicine, DKD, will be administrated for 3 months before the IVF/ICSI cycle starts. The primary outcome of the study is the ongoing pregnancy rate at 12 weeks' gestation. The secondary outcomes include total gonadotropin dosage, duration of stimulation, estradiol (E Discussion: IVF/ICSI is increasingly used to treat couples desiring a baby. Many of these women will have poor ovarian function. In China, DKD is commonly used for these patients prior to undergoing IVF/ICSI. There is no effective treatment for poor ovarian response in Western medicine currently. It is important, therefore, to undertake this randomized control trial to determine whether DKD is effective or not. Trial registration: Chinese Clinical Trial Registry, ID: ChiCTR-IOR-17011697 . Registered on 19 June 2017. |
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| MeSH term(s) | Adult ; Clinical Trials, Phase III as Topic ; Data Interpretation, Statistical ; Female ; Fertilization in Vitro ; Humans ; Infertility, Female/blood ; Infertility, Female/drug therapy ; Medicine, Chinese Traditional/adverse effects ; Multicenter Studies as Topic ; Pregnancy ; Pregnancy Rate ; Randomized Controlled Trials as Topic ; Sample Size ; Sperm Injections, Intracytoplasmic |
| Language | English |
| Publishing date | 2018-02-20 |
| Publishing country | England |
| Document type | Clinical Trial Protocol ; Journal Article |
| ZDB-ID | 2040523-6 |
| ISSN | 1745-6215 ; 1468-6694 ; 1468-6708 |
| ISSN (online) | 1745-6215 ; 1468-6694 |
| ISSN | 1468-6708 |
| DOI | 10.1186/s13063-018-2511-0 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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