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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose of oestrogen | Experimental | 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. |
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| High dose of oestrogen | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femoston | Drug | Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone. |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fu Xing Hospital,Capital Medical University | Beijing | Beijing Municipality | 100038 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | 2mg Estradiol Therapy(Low Dose) | 2mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment. Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone. |
| FG001 | 6mg Estradiol Therapy(High Dose) | 6mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment. Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 2mg Estradiol Therapy(Low Dose) | mean Age(y):31.9 Gender:Female BMI:21.2 mean Number of miscarriage: 2.3 BMI=body mass index |
| BG001 | 6mg Estradiol Therapy(High Dose) | mean Age(y):32.3 Gender:Female BMI:21.0 mean Number of miscarriage: 2.1 BMI=body mass index |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Standard Deviation | units on a scale | 1 months after the surgery |
|
2 months after estradiol therapy
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2mg Estradiol Therapy(Low Dose) | 2mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment. Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nauseated and bloated | Reproductive system and breast disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. YH Liu | Department of Hysteroscopic Center, Fuxing Hospital, Capital Medical University, Beijing, China | 8618301474064 | emmagj@126.com |
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| ID | Term |
|---|---|
| D006175 | Gynatresia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C472241 | femoston |
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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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Parity | Parity means the number of past deliveries. | Mean | Standard Deviation | times |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | 2 months after surgery |
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| 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. | Posted | Number | participants | 3 months after surgery |
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| 0 |
| 59 |
| 6 |
| 59 |
| EG001 | 6mg Estradiol Therapy(High Dose) | 6mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment. Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone. | 0 | 62 | 11 | 62 |
| abnormal liver function | Hepatobiliary disorders | Non-systematic Assessment |
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| D000091662 | Genital Diseases |