Comparison of Different Doses of Oestrogen Therapy for Preventing Intrauterine Adhesion

Phase 1

Completed

• Conditions: Asherman Syndrome
• Interventions: Drug: Femoston

• Registration Number: NCT02726971
• Lead Sponsor: Fu Xing Hospital, Capital Medical University

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 Description

Not available

Study Timeline

• Study First Submitted: 2016-03-22
• Study First Submitted QC: 2016-03-29
• Study Start: 2016-04
• Study First Posted: 2016-04-04
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Results First Submitted: 2016-12-02
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-06
• Last Update Submitted: 2017-04-06
• Results First Posted: 2017-04-10
• Last Update Posted: 2017-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 141

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose of oestrogen	Femoston	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.
High dose of oestrogen	Femoston	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.

Primary Outcome Measures

Name	Time	Method
the AFS Score at Second-look Hysteroscopy	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 Outcome Measures

Name	Time	Method
the AFS Score at Third-look Hysteroscopy	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	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.

Trial Locations

Locations (1)

Fu Xing Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, China