Clinical Trial: Comparison of Different Doses of Oestrogen Therapy for Preventing Intrauterine Adhesion

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official 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

Brief Summary: 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.

Detailed Summary:
Sponsor: Fu Xing Hospital, Capital Medical University

Current Primary Outcome: 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.


Original Primary Outcome: The improvement in stage of Intrauterine Adhesion according to the American Fertility Society Classification of Uterine(AFS) [ Time Frame: 3 months after the surgery ]

Current Secondary Outcome:

  • 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.
  • 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.


Original Secondary Outcome:

  • The baseline endometrial thickness [ Time Frame: 3 months after surgery ]
  • The restoration of normal menstrual pattern [ Time Frame: 3 months after surgery ]


Information By: Fu Xing Hospital, Capital Medical University

Dates:
Date Received: March 22, 2016
Date Started: April 2016
Date Completion:
Last Updated: April 6, 2017
Last Verified: April 2017