Comparison of Different Doses of Oestrogen Therapy for Preventing Intrauterine Adhesion
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ClinicalTrials.gov Identifier: NCT02726971 |
Recruitment Status :
Completed
First Posted : April 4, 2016
Results First Posted : April 10, 2017
Last Update Posted : April 10, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asherman Syndrome | Drug: Femoston | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 141 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Prevention |
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 |
Study Start Date : | April 2016 |
Actual Primary Completion Date : | August 2016 |
Actual Study Completion Date : | August 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Low dose of oestrogen
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
Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone. |
Active Comparator: High dose of oestrogen
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
Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone. |
- the AFS Score at Second-look Hysteroscopy [ Time Frame: 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.
- the AFS Score at Third-look Hysteroscopy [ Time Frame: 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 [ Time Frame: 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.

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Ages Eligible for Study: | 25 Years to 45 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02726971
China, Beijing | |
Fu Xing Hospital,Capital Medical University | |
Beijing, Beijing, China, 100038 |
Responsible Party: | Jun Guo, Chief Physician, Fu Xing Hospital, Capital Medical University |
ClinicalTrials.gov Identifier: | NCT02726971 |
Other Study ID Numbers: |
LYuhuan |
First Posted: | April 4, 2016 Key Record Dates |
Results First Posted: | April 10, 2017 |
Last Update Posted: | April 10, 2017 |
Last Verified: | April 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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