A Prospective, Randomized, Controlled Trial Comparing 2 Different Doses of Estrogen Therapy After Hysteroscopic Adhesiolysis as an Adjuvant to Prevent Recurrence of Intrauterine Adhesions
Overview
- Phase
- Phase 1
- Intervention
- Femoston
- Conditions
- Asherman Syndrome
- Sponsor
- Fu Xing Hospital, Capital Medical University
- Enrollment
- 141
- Locations
- 1
- Primary Endpoint
- the AFS Score at Second-look Hysteroscopy
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Jun Guo
Chief Physician
Fu Xing Hospital, Capital Medical University
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.
Arms & Interventions
Low dose of oestrogen
Patients in this group will build artificial cycle by Femoston.(oral one red tablet daily for 11 days and oral one yellow tablet in the next 10 days). This process will last for 3 months after the surgery. P.S.1.A red tablet contains 2mg estradiol. 2.A yellow tablet contains 2mg estradiol and 10mg dydrogesterone.
Intervention: Femoston
High dose of oestrogen
Patients in this group will build artificial cycle by Femoston.(oral three red tablets daily for 11 days and oral two yellow tablets in the next 10 days). This process will last for 3 months after the surgery. P.S.1.A red tablet contains 2mg estradiol. 2.A yellow tablet contains 2mg estradiol and 10mg dydrogesterone.
Intervention: Femoston
Outcomes
Primary Outcomes
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
- the AFS Score at Third-look Hysteroscopy(2 months after surgery)
- Participants With Improvement of Menstrual Pattern at Third-look Hysteroscopy(3 months after surgery)