Clinical trial · Interventional
Effect of Fertility-sparing Therapy of Early Endometrial Cancer
NCT03538704CI-TRIAL-00033102ECFerSpunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to investigate the effect of Fertility-sparing Therapy of Early Endometrial Cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Fertility | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Metformin | Drug | Metformin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- BMI≥25 group with metformin
- description
- Patients with BMI≥25kg/m2 in the experimental group are treated with medroxyprogesterone acetate (MPA) 0.25g/d plus metformin and are followed-up of baseline data, hormone levels,
- interventionNames
- Drug: Metformin
- type
- NO_INTERVENTION
- label
- BMI≥25 group without metformin
- description
- Patients with BMI≥25kg/m2 in the none intervention group are treated with MPA 0.25g/d alone and are followed-up of baseline data, hormone levels, and endometrial pathology every 3 months until 12 months.
Primary outcomes (1)
- measure
- Complete response rate
- timeFrame
- through study completion, an average of 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * ages of no more than 40 * with a strong desire of fertility preservation * International Federation of Gynecology and Obstetrics (FIGO) 2009 stage Ⅰa grade 1\~2 with lesion confined in endometrium * pathology expression of progestin receptors (PRs) and estrogen receptors Exclusion Criteria: * not eligible for pregnancy or delivery * evidence of suspected extrauterine or distant metastasis * complicated with any other malignancy * severe medical complications * contraindication of oral progestin * uncontrolled epilepsy, central nervous system disease or mental disorder history in patients which Influence clinical research compliance judging by the researcher.
References
Publications (1)
- RESULTGallos ID, Yap J, Rajkhowa M, Luesley DM, Coomarasamy A, Gupta JK. Regression, relapse, and live birth rates with fertility-sparing therapy for endometrial cancer and atypical complex endometrial hyperplasia: a systematic review and metaanalysis. Am J Obstet Gynecol. 2012 Oct;207(4):266.e1-12. doi: 10.1016/j.ajog.2012.08.011. Epub 2012 Aug 10. PMID 23021687