Comparison of Different Doses of Oestrogen Therapy for Preventing Intrauterine Adhesion

Asherman Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02726971
• Other study ID #: LYuhuan
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 22, 2016
• Last updated: April 6, 2017
• Start date: April 2016
• Est. completion date: August 2016

Study information

• Verified date: April 2017
• Source: Fu Xing Hospital, Capital Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Moderate and severe IUA according to the AFS IU adhesion scoring system (AFS 1988 version) (19) showed in Table1 (AFS score=5);

2. Scheduled for hysteroscopic adhesiolysis;

3. Agreed to have two follow-up hysteroscopy; and

4. Written, informed consent obtained.

Exclusion Criteria:

1. Received estrogen therapy within 3 months of enrollment;

2. Suffering from leiomyoma, polyps, cancer, or polycystic ovarian syndrome (PCOS);

3. History of genital tuberculosis; and

4. Contraindication for estrogen therapy.

Related Conditions & MeSH terms

• Asherman Syndrome
• Tissue Adhesions

Intervention

Drug:
• Femoston
Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone.

Locations

Country	Name	City	State
China	Fu Xing Hospital,Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Fu Xing Hospital, Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the AFS Score at Second-look Hysteroscopy	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.	1 months after the surgery
Secondary	the AFS Score at Third-look Hysteroscopy	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 months after surgery
Secondary	Participants With Improvement of Menstrual Pattern at Third-look Hysteroscopy	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.	3 months after surgery