Evidence map›Paper›PMID 38129882›Full record

ArticleTrials2023

Effect of transvaginal Lactobacillus supplementation on reversing lower genital tract dysbiosis and improving perinatal outcomes in PCOS patients after IVF-FET: a study protocol for a multicenter randomized controlled trial.

Huixi Chen, Yaoyao Tu, Chen Zhang, Jie Li, Ting Wu, Suying Liu, Liying He, Aijun Zhang, Yan Li, Lu Li and 7 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
–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

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
  3. All Properties of Infertility Microbiome in a Review Article.Journal of clinical laboratory analysis · 2025
    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

17 authors.

Huixi Chen *Obstetrics and Gynecology Hospital, Institute of Reproduction and Development, Fudan University, Shanghai, China.
Yaoyao Tu *Obstetrics and Gynecology Hospital, Institute of Reproduction and Development, Fudan University, Shanghai, China.
Chen Zhang *Obstetrics and Gynecology Hospital, Institute of Reproduction and Development, Fudan University, Shanghai, China.
Jie LiObstetrics and Gynecology Hospital, Institute of Reproduction and Development, Fudan University, Shanghai, China.
Ting WuThe International Peace Maternal and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Suying LiuReproductive Center, Zhong Shan Hospital, Shanghai, China.
Liying HeReproductive Center, Zhong Shan Hospital, Shanghai, China.
Aijun ZhangReproductive Medical Center, Department of Obstetrics and Gynecology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Yan LiReproductive Medical Center, Department of Obstetrics and Gynecology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.
Lu LiShangHai JIAI Genetics and IVF Institute, Shanghai, China.
Yilun SuiShangHai JIAI Genetics and IVF Institute, Shanghai, China.
Li WangThe International Peace Maternal and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Xiaojun ChenThe International Peace Maternal and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Ji XiThe International Peace Maternal and Child Health Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Yanting WuObstetrics and Gynecology Hospital, Institute of Reproduction and Development, Fudan University, Shanghai, China. yanting_wu@163.com.
Li JinObstetrics and Gynecology Hospital, Institute of Reproduction and Development, Fudan University, Shanghai, China. jinl@fudan.edu.cn.
He-Feng HuangObstetrics and Gynecology Hospital, Institute of Reproduction and Development, Fudan University, Shanghai, China. huanghefg@hotmail.com.

Funding

Clinical Research Plan of SHDC No. SHDC2020CE1008A
6 · The paper itself

Abstract

backgroundSignificant lower genital tract (LGT) dysbiosis and an associated lower rate of clinical pregnancy after in vitro fertilization-frozen embryo transfer (IVF-FET) among polycystic ovary syndrome (PCOS) patients have been previously reported by our group. We aimed to assess whether transvaginal Lactobacillus supplementation can reverse LGT dysbiosis and further improve perinatal outcomes in PCOS patients after IVF-FET. METHODS/

designThis is a protocol for a multicenter, open-label, randomized controlled trial in China. Women diagnosed with PCOS who are undergoing IVF-FET treatment will be recruited. Allocation to the intervention/control arms at a ratio of 1:1 will be executed by an electronic randomization system. Participants in the intervention arm will receive the live Lactobacillus capsule vaginally for 10 consecutive days before embryo transfer, while those in the control arm will receive standard individualized care. The primary outcomes will be the clinical pregnancy rate, implantation rate, and live birth rate. 16S rRNA sequencing and liquid chromatography-mass spectrometry will be conducted to evaluate the LGT microbiome and systemic metabonomics before and after the intervention. A sample of 260 participants will provide 95% power to detect a 20% increase in the rate of clinical pregnancy (α = 0.025, one-tailed test, 15% dropout rate). A total of 300 participants will be recruited. DISCUSSION: This is the first large and multicenter randomized controlled trial aimed at assessing the efficacy of transvaginal Lactobacillus supplementation on restoring the LGT microbiome and improving perinatal outcomes in PCOS patients after IVF-FET. This pragmatic trial is promising for increasing the rates of clinical pregnancy and live birth in PCOS patients after IVF-FET. ETHICS AND DISSEMINATION: Ethical review approval was obtained from the Medical Research Ethics Committees of the International Peace Maternity and Child Health Hospital of Shanghai Jiao Tong University (15 October 2020, GKLW 2020-29). To maximize dissemination, these findings will be reported in open access publications in journals with high impact, and oral and poster conference presentations will be performed.

trial registrationChiCTR ChiCTR2000036460. Registered on 13 September 2020, https://www.chictr.org.cn/showproj.html?proj=59549 .

Indexed as

Polycystic Ovary SyndromeChildChinaDietary SupplementsDysbiosisFemaleFertilization in VitroHumansMulticenter Studies as TopicPragmatic Clinical Trials as TopicPregnancyPregnancy RateRandomized Controlled Trials as TopicRNA, Ribosomal, 16SRNA, Ribosomal, 16SClinical pregnancyIn vitro fertilization–frozen embryo transferLive birthLive Lactobacillus capsule for vaginal useLower genital tract microbiomePolycystic ovary syndromeRandomized controlled trialStudy protocol

Identifiers

PMID38129882
PMCPMC10734052

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.