Value of LNG-IUS as Fertility-preserving Treatment of EAH and EC

  • STATUS
    Recruiting
  • End date
    Dec 30, 2030
  • participants needed
    224
  • sponsor
    West China Second University Hospital
Updated on 24 January 2021
carcinoma
progesterone
levonorgestrel
metastasis
immunohistochemistry
uterine disease
histological diagnosis
mirena
hyperplasia
endometrial carcinoma
endometrial hyperplasia
atypical endometrial hyperplasia

Summary

Primary end points:

This clinical trial is aimed to analyze the effectiveness of Levonorgestrel-Releasing Intrauterine System (LNG-IUS, Mirena) in the fertility-sparing treatment of atypical endometrial hyperplasia and early endometrial carcinoma, including pathology response and pregnancy outcome.

Second end points:

To analyze the appearances of side-effects.

Details
Condition Endometrial Carcinoma, Disorder of uterus NOS, Uterine Cancer, Endometrial Hyperplasia, Endometrial Cancer, Uterine Disorders, atypical endometrial hyperplasia
Treatment progesterone, GnRH agonist, Mirena®
Clinical Study IdentifierNCT03463252
SponsorWest China Second University Hospital
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age less than or equal to 40 yrs?
Are you female?
Do you have any of these conditions: Endometrial Hyperplasia or Endometrial Cancer or Uterine Cancer or Disorder of uterus NOS or Uterine Disorders or Endometrial Carcinoma?
Do you have any of these conditions: Disorder of uterus NOS or Endometrial Hyperplasia or Uterine Disorders or Endometrial Cancer or Endometrial Carcinoma or atypical endometrial hyperpla...?
years of age
Having a strong desire for fertility preservation
Histological diagnosis is confirmed as atypical endometrial hyperplasia (EAH) by the designated gynecological pathologists
Having volunteered to participate in this study, signed the informed consent form, and agreed to participate in clinical follow-up

Exclusion Criteria

Patients have allergies or contraindications (except for thromboembolic disease, liver dysfunction, hypertension, and diabetes) for the involved drugs
Patients have contraindications for pregnancy
Patients have serious underlying disease, malignancies at other site(s), acute liver or kidney disease, acute or subacute genital tract infections, and congenital or acquired abnormal uterine development (that may make intrauterine device placement impossible)
Patients refuse to participate in clinical follow-up or sign the informed consent form
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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