Phase 2
Completed N=141
Comparison of Different Doses of Oestrogen Therapy for Preventing Intrauterine Adhesion
Asherman Syndrome
Source: ClinicalTrials.gov NCT02726971 ↗
Enrolled (actual)
141
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcomePrimary: the AFS Score at Second-look Hysteroscopy — 1.6; 1.9 units on a scale — p=>0.05
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the AFS Score at Second-look Hysteroscopy |
1.6; 1.9 | >0.05 |
| SECONDARY the AFS Score at Third-look Hysteroscopy |
1.0; 1.2 | — |
| SECONDARY Participants With Improvement of Menstrual Pattern at Third-look Hysteroscopy |
38; 44 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02726971). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.