Comparison of Different Doses of Oestrogen Therapy for Preventing Intrauterine Adhesion

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Randomized, Controlled Trial Comparing 2 Different Doses of Estrogen Therapy After Hysteroscopic Adhesiolysis as an Adjuvant to Prevent Recurrence of Intrauterine Adhesions

Conditions
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Asherman Syndrome

Intervention / Treatment
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* Drug: Femoston


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low dose of oestrogen<br>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. | Drug: Femoston<br>* Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone.<br>|
| Active Comparator: High dose of oestrogen<br>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. | Drug: Femoston<br>* Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrauterine Adhesion, Oestrogen Artificial Periodic Therapy