Evidence map›Paper›PMID 33109663›Full record

ArticleBMJ open2020

Effects of oil-soluble versus water-soluble contrast media at hysterosalpingography on pregnancy outcomes in women with a low risk of tubal disease: study protocol for a randomised controlled trial.

Guiling Liang, Qian Zhu, Xiaoqing He, Xiaofeng Wang, Ling Jiang, Chenfeng Zhu, Li Xie, Zhaoxia Qian, Jian Zhang

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2020. 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
0.5field-weighted citation impact, top 28% of its field
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, 6 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. Review
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

9 authors at 1 institution in 1 country.

Guiling LiangDepartment of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Qian ZhuDepartment of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Xiaoqing HeDepartment of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Xiaofeng WangDepartment of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Ling JiangShanghai Key Laboratory Embryo Original Diseases, Shanghai, China.
Chenfeng ZhuDepartment of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Li XieClinical Research Institute, Shanghai Jiao Tong University School of Medicine, Shanghai, China.ORCID 0000-0003-1892-2217
Zhaoxia QianShanghai Key Laboratory Embryo Original Diseases, Shanghai, China zhaoxiaqian@163.com zhangjian_sjtu@126.com.
Jian ZhangDepartment of Obstetrics and Gynecology, International Peace Maternity and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China zhaoxiaqian@163.com zhangjian_sjtu@126.com.ORCID 0000-0003-3664-5807
Shanghai Jiao Tong University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn recent years, due to various factors, the rate of infertility in China has increased and now affects over 10% of women of reproductive age. Hysterosalpingography (HSG) is a common diagnostic procedure during fertility examinations. However, there is no consensus on the choice of contrast agents and their effects. As the largest multicentre, randomised controlled trial (H2Oil trial from the Netherlands) has shown that oil-soluble contrast at HSG can enhance fertility compared with water-soluble contrast, we propose this study to examine whether the use of oil-soluble contrast media results in increased rates of pregnancy in Chinese women undergoing HSG. METHODS AND ANALYSIS: This study is a single-centre, randomised, controlled, parallel-group, superiority trial. Patients with low risk of tubal disease will be randomised to undergo HSG using iodinated oil injection (OSCM group, oil-soluble contrast media) or ioversol injection (WSCM group, water-soluble contrast media). To evaluate the potential superiority of the OSCM group, with 1:1 allocation ratio, 90% statistical power and a two-sided significance level of 5%, we have calculated a sample of 520 women per group to be enrolled, for a total of 1040 including 10% loss to follow-up or protocol variation. The primary outcome is the rate of ongoing pregnancy during 6 months after randomisation. The secondary outcomes will consist of thyroid function of patients and newborns, pain scores during HSG, rate of live birth, clinical pregnancies, miscarriages, ectopic pregnancy, time to ongoing pregnancy, time to live birth, cost calculations of the OSCM group/WSCM group, and assisted reproductive technology treatments between the two groups. ETHICS AND DISSEMINATION: This protocol received authorisation from the Medical Research Ethics Committee of International Peace Maternity and Child Health Hospital on 18 January 2020 (approval no GKLW2020-02). The findings will be reported in peer-reviewed publications and presentations at international scientific meetings. TRIAL REGISTRATION NUMBER: ChiCTR2000031612.

Indexed as

HysterosalpingographyInfertility, FemaleChildChinaContrast MediaEquivalence Trials as TopicFemaleHumansInfant, NewbornMulticenter Studies as TopicNetherlandsPregnancyPregnancy OutcomePregnancy RateRandomized Controlled Trials as TopicWaterContrast MediaWaterdiagnostic radiologygynaecologysubfertility

Identifiers

PMID33109663
PMCPMC7597517
OpenAlexW3097142397

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.