Evidence map›Paper›PMID 29458401›Full record

ArticleTrials2018

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.

Saihua Ma, Ruihong Ma, Tian Xia, Masoud Afnan, Xueru Song, Fengqin Xu, Guimin Hao, Fangfang Zhu, Jingpei Han, Zhimei Zhao

Abstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Saihua MaReproductive Center, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, No. 88 Chang Ling Street, Xi Qing district, Tianjin, 300112, China.
Ruihong MaReproductive Center, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, No. 88 Chang Ling Street, Xi Qing district, Tianjin, 300112, China.
Tian XiaReproductive Center, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, No. 88 Chang Ling Street, Xi Qing district, Tianjin, 300112, China. xiatian76@163.com.ORCID http://orcid.org/0000-0001-5285-0064
Masoud AfnanCenter of Reproductive Medicine, Tianjin United Family Hospital and Clinics, No. 22 Tanjiang Street, Hexi district, Tianjin, 300221, China.
Xueru SongCenter of Reproductive Medicine, General Hospital of Tianjin Medical University, No. 154 Anshan Street, Nankai district, Tianjin, 300052, China.
Fengqin XuCenter of Reproductive Medicine, Tianjin First Center Hospital, No. 24 Fukang Road, Nankai district, Tianjin, 300190, China.
Guimin HaoCenter of Reproductive Medicine, The Second Hospital of Hebei Medical University, No. 215 Heping West Road, Xinhua district, Shijiazhuang, 050000, China.
Fangfang ZhuThe Graduate School, Tianjin University of Traditional Chinese Medicine, No. 312 Anshan West Road, Nankai district, Tianjin, 300073, China.
Jingpei HanThe Graduate School, Tianjin University of Traditional Chinese Medicine, No. 312 Anshan West Road, Nankai district, Tianjin, 300073, China.
Zhimei ZhaoReproductive Center, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, No. 88 Chang Ling Street, Xi Qing district, Tianjin, 300112, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWomen 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/

designThis 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 registrationChinese Clinical Trial Registry, ID: ChiCTR-IOR-17011697 . Registered on 19 June 2017.

Indexed as

Fertilization in VitroMedicine, Chinese TraditionalRandomized Controlled Trials as TopicSperm Injections, IntracytoplasmicAdultClinical Trials, Phase III as TopicData Interpretation, StatisticalEquivalence Trials as TopicFemaleHumansInfertility, FemaleMulticenter Studies as TopicPregnancyPregnancy RateSample SizeAssisted reproductive technologyDiminished ovarian reserveDing-Kun-DanICSIInfertilityIVFPoor ovarian reserveTCMTraditional Chinese medicine

Identifiers

PMID29458401
PMCPMC5819272

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.