Evidence map›Paper›PMID 36333773›Full record

ArticleReproductive health2022

Levonorgestrel-releasing intrauterine device plus metformin, or megestrol acetate plus metformin for fertility-sparing treatment of atypical endometrial hyperplasia and early endometrial carcinoma: a prospective, randomized, blind-endpoint design trial protocol.

Xin Zhao, Jumin Niu, Cong Shi, Zhihui Liu

Open access · goldFull text readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Reproductive health, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.8field-weighted citation impact, top 14% 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

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Endometrial cancer and simultaneous pregnancy, an unusual combination. Case report.The journal of obstetrics and gynaecology research · 2025
    Article
  3. Review
  4. Article
  5. Article
  6. Review
  7. 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

4 authors at 1 institution in 1 country.

Xin ZhaoShenyang Women's and Children's Hospital, No. 87, Renao Road, Danan Street, Shenhe District, Shenyang, Liaoning, China.
Jumin NiuShenyang Women's and Children's Hospital, No. 87, Renao Road, Danan Street, Shenhe District, Shenyang, Liaoning, China. tgzyyx007@163.com.
Cong ShiShenyang Women's and Children's Hospital, No. 87, Renao Road, Danan Street, Shenhe District, Shenyang, Liaoning, China.
Zhihui LiuShenyang Women's and Children's Hospital, No. 87, Renao Road, Danan Street, Shenhe District, Shenyang, Liaoning, China.
Shenyang First People's Hospital · CN

Funding

Shenyang Young and middle-aged Scientific and technological Innovation Talents Support Program RC210200
6 · The paper itself

Abstract

backgroundEndometrial adenocarcinoma (EC) is the fifth most common cancer in women worldwide, standard treatment for EC includes hysterectomy, but it results in the loss of reproductive function. Thus, conservative treatment for these patients is strongly demanded, progestin therapy is widely accepted as the main fertility-sparing treatment for young women with endometrial hyperplasia with atypia (EHA) and well-differentiated endometrioid endometrial cancer. This trial will investigate the effectiveness of conservative treatment for obese women with early-stage EC. METHOD AND

designThis will be an open-label, 2-armed, randomized, phase-II single-center trial of LNG-IUD plus metformin or megestrol acetate (MA) plus metformin. A total of 88 participants will be randomly assigned into 2 treatment arms in a 1:1 ratio. Clinical, laboratory, ultrasound and radiology data, will be collected at baseline, and then at 3, 6, 9, 12, 18, and 24 months. EC biomarkers will be collected at baseline. The primary aim is to determine the efficacy of a levonorgestrel-releasing intrauterine device (LNG-IUD) plus metformin, or megestrol acetate (MA) plus metformin in achieving pathological complete response (pCR) at 12 months, as well as post-treatment pregnancy outcomes and recurrence rate. The secondary aims are to predict the response to an LNG-IUD plus metformin and MA plus metformin via clinical, blood, and tissue predictive biomarkers.

conclusionsProspective evidence for conservative treatment of EC is limited. New methods to achieve better CR rates with fewer side effects are needed. This trial will investigate the effectiveness of LNG-IUD plus metformin, and MA plus metformin, in obese women with early-stage EC, providing a non-surgical treatment option for these patients. Trial registration ChiCTR2200055624. The trial was registered at http://www.chictr.org.cn/listbycreater.aspx on January 15, 2022.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsEndometrial HyperplasiaEndometrial NeoplasmsIntrauterine Devices, MedicatedLevonorgestrelFemaleHumansMegestrol AcetateMetforminObesityPregnancyProspective StudiesRandomized Controlled Trials as TopicLevonorgestrelMegestrol AcetateMetformin

Identifiers

PMID36333773
PMCPMC9636609
OpenAlexW4308303217

What OpenQuestion holds

Textfull text, public
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 OpenQuestion graph.