Evidence map›Paper›PMID 39215793›Full record

Trial reportJournal of assisted reproduction and genetics2024

A multi-centre randomised controlled trial comparing megestrol acetate to levonorgestrel-intrauterine system in fertility sparing treatment of atypical endometrial hyperplasia.

Charissa Shu Ying Goh, Michelle Jia Min Loh, Whui Whui Lim, Joella Xiahong Ang, Ravichandran Nadarajah, Tze Tein Yong, Pearl Tong, Yen Ching Yeo, Jessie Wai Leng Phoon

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
In one paragraph

Trial report in Journal of assisted reproduction and genetics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05492487 (A Pilot Study on Fertility Conservative Treatment of Atypical Endometrial Hyperplasia in Singapore), which is not on this map. Cited by 7 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 2 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.

NCT05492487 phase2unknown statusnot on this map

A Pilot Study on Fertility Conservative Treatment of Atypical Endometrial Hyperplasia in Singapore

TypeinterventionalSponsorKK Women's and Children's HospitalRan2020 to 2023Enrolled60ConditionsEndometrial Hyperplasia, Fertility Issues, Disease Regression, Treatment Side EffectsArmsMirena, Megace
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Review
  5. Review
  6. Review
  7. Article
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.

Charissa Shu Ying GohDepartment of Reproductive Medicine, KK Women's and Children's Hospital, 100 Bukit Timah Road, Singapore, 229899, Singapore. charissa.goh11@gmail.com.ORCID http://orcid.org/0000-0003-2692-2567
Michelle Jia Min LohDepartment of Reproductive Medicine, KK Women's and Children's Hospital, 100 Bukit Timah Road, Singapore, 229899, Singapore.
Whui Whui LimDepartment of Obstetrics & Gynaecology, Singapore General Hospital, Singapore, Singapore.
Joella Xiahong AngDepartment of Obstetrics & Gynaecology, Singapore General Hospital, Singapore, Singapore.
Ravichandran NadarajahDepartment of Obstetrics & Gynaecology, Singapore General Hospital, Singapore, Singapore.
Tze Tein YongDepartment of Obstetrics & Gynaecology, Singapore General Hospital, Singapore, Singapore.
Pearl TongDivision of Gynaecologic Oncology, National University Hospital, Singapore, Singapore.
Yen Ching YeoDepartment of Pathology and Laboratory Medicine, KK Women's and Children's Hospital, Singapore, Singapore.
Jessie Wai Leng PhoonDepartment of Reproductive Medicine, KK Women's and Children's Hospital, 100 Bukit Timah Road, Singapore, 229899, Singapore.

Funding

SingHealth AM/CT004/2020
6 · The paper itself

Abstract

purposeThe objective of the trial was to compare the regression rate of atypical endometrial hyperplasia (AEH) in patients treated with megestrol acetate (MA) vs. levonorgestrel-intrauterine device (LNG-IUS). We also aimed to assess the fertility and pregnancy outcomes in these patients.

methodsThe study was a phase II multi-centre randomised controlled trial on the use of MA compared to LNG-IUS in the treatment of AEH conducted from January 2020 to January 2024 in Singapore. Women who were diagnosed with AEH and between 21 and 40 years old were included. The patients were randomised to receive either MA (160 mg orally daily) or LNG-IUS. The primary outcomes assessed were the regression rates at 3 months, 6 months and 9 months of treatment. The secondary outcomes assessed were the side effects, patient acceptability and fertility outcomes.

resultsThirty-six patients completed the trial. The overall regression rate was 88.9% by 9 months. There was no statistically significant difference in the 9-month complete regression rate between MA vs. LNG-IUS. There was also no significant difference in side effects and weight change between both arms. Nineteen patients were actively pursuing fertility after complete regression. There were 8 pregnancies achieved, with resultant 4 live births and 4 miscarriages.

conclusionOur study confirms a high regression rate of AH with medical treatment. LNG-IUS is a non-inferior treatment compared to megestrol acetate. Successful pregnancy outcomes can be achieved after regression of AEH. Long-term studies of sufficient sample-size are needed to assess for fertility and pregnancy outcomes, risk of recurrence and long-term risk of malignancy. TRIAL REGISTRATION NUMBER: The study was registered with the Health Science Authority (HSA) (License No.: CTA1900087) on September 5, 2019: https://eservice.hsa.gov.sg/prism/ct_r/enquiry.do?action=loadSpecificDetail . The trial was registered retrospectively on ClinicalTrials.gov (ID: NCT05492487) on April 7, 2022: https://clinicaltrials.gov/study/NCT05492487 .

Indexed as

Endometrial HyperplasiaFertility PreservationIntrauterine Devices, MedicatedLevonorgestrelMegestrol AcetateAdultFemaleHumansPregnancyPregnancy OutcomePregnancy RateYoung AdultLevonorgestrelMegestrol AcetateAtypical endometrial hyperplasiaFertilityLevonorgestrel-intrauterine systemMegestrol acetateRandomised controlled trial

Identifiers

PMID39215793
PMCPMC11405348

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Registered trials

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.