Asherman Syndrome
Conditions
Keywords
Intrauterine Adhesion, Oestrogen Artificial Periodic Therapy
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.
Interventions
DRUGFemoston
Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone.
Sponsors
Fu Xing Hospital, Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 59 |
| 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 | 62 |
| Total | 121 |
Baseline characteristics
| Characteristic | 2mg Estradiol Therapy(Low Dose) | 6mg Estradiol Therapy(High Dose) | Total |
|---|---|---|---|
| Age, Continuous | 31.9 years STANDARD_DEVIATION 5 | 32.3 years STANDARD_DEVIATION 4.1 | 32.3 years STANDARD_DEVIATION 4.6 |
| Parity | 0.2 times STANDARD_DEVIATION 0.4 | 0.2 times STANDARD_DEVIATION 0.4 | 0.2 times STANDARD_DEVIATION 0.4 |
| Sex: Female, Male Female | 59 Participants | 62 Participants | 121 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 59 | 11 / 62 |
| serious Total, serious adverse events | 0 / 59 | 0 / 62 |
Outcome results
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.
Time frame: 1 months after the surgery
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| 2mg Estradiol Therapy(Low Dose) | the AFS Score at Second-look Hysteroscopy | 1.6 units on a scale | Standard Deviation 1.4 |
| 6mg Estradiol Therapy(High Dose) | the AFS Score at Second-look Hysteroscopy | 1.9 units on a scale | Standard Deviation 1.6 |
p-value: >0.05t-test, 2 sided
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.
Time frame: 3 months after surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 2mg Estradiol Therapy(Low Dose) | Participants With Improvement of Menstrual Pattern at Third-look Hysteroscopy | 38 participants |
| 6mg Estradiol Therapy(High Dose) | Participants With Improvement of Menstrual Pattern at Third-look Hysteroscopy | 44 participants |
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.
Time frame: 2 months after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2mg Estradiol Therapy(Low Dose) | the AFS Score at Third-look Hysteroscopy | 1.0 units on a scale | Standard Deviation 1.1 |
| 6mg Estradiol Therapy(High Dose) | the AFS Score at Third-look Hysteroscopy | 1.2 units on a scale | Standard Deviation 1.4 |