Skip to main content
OpenTrials
Completed

NCT Number: NCT02726971

Comparison of Different Doses of Oestrogen Therapy for Preventing Intrauterine Adhesion

This single-center,prospective,randomized,controlled trial is conducted to evaluate the efficacy of different doses of estrogen artificial periodic therapy after hysteroscopic adhesiolysis in patients with moderate-severe adhesion.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asherman Syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gynatresia Urogenital Diseases

Age range

25 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Fu Xing Hospital,Capital Medical University

Beijing, Beijing Municipality, 100038, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Moderate and severe IUA according to the AFS IU adhesion scoring system (AFS 1988 version) (19) showed in Table1 (AFS score≥5);
  • Scheduled for hysteroscopic adhesiolysis;
  • Agreed to have two follow-up hysteroscopy; and
  • Written, informed consent obtained.

Exclusion criteria

  • Received estrogen therapy within 3 months of enrollment;
  • Suffering from leiomyoma, polyps, cancer, or polycystic ovarian syndrome (PCOS);
  • History of genital tuberculosis; and
  • Contraindication for estrogen therapy.

Treatment and study plan

Femoston

Drug

Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone.

Primary outcomes

  1. the AFS Score at Second-look Hysteroscopy

    Time frame: 1 months after the surgery

    The AFS score is based on the American Fertility Society (AFS) Classification of Intra-uterine adhesions( 1988 version)The total range of AFS score is from 0 to 12, and the higher the score is, the worse the outcome is.

Secondary outcomes

  1. the AFS Score at Third-look Hysteroscopy

    Time frame: 2 months after surgery

    The AFS score is based on the American Fertility Society (AFS) Classification of Intra-uterine adhesions( 1988 version)The total range of AFS score is from 0 to 12, and the higher the score is, the worse the outcome is.

  2. Participants With Improvement of Menstrual Pattern at Third-look Hysteroscopy

    Time frame: 3 months after surgery

    The menstrual pattern is clarified as four types which includes amenorrhea, scant spotting, light period, normal period. The menstrual pattern of every participant was recored and compared with herself (before and 3 months after surgery). The number showed below is patients whose menstrual pattern had improved after surgery and estrogen therapy.

Sponsors and collaborators

Lead sponsor

Fu Xing Hospital, Capital Medical University

Other

Registry information

Official study title

A Prospective, Randomized, Controlled Trial Comparing 2 Different Doses of Estrogen Therapy After Hysteroscopic Adhesiolysis as an Adjuvant to Prevent Recurrence of Intrauterine Adhesions

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 4, 2016
Registry last updated
Apr 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.