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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
Sponsor:
Information provided by (Responsible Party):
Jun Guo, Fu Xing Hospital, Capital Medical University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Asherman Syndrome Drug: Femoston Phase 1 Phase 2

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions
Drug Information available for: Estrogens

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


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

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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China, Beijing
Fu Xing Hospital,Capital Medical University
Beijing, Beijing, China, 100038
Sponsors and Collaborators
Fu Xing Hospital, Capital Medical University
More Information
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Responsible Party: Jun Guo, Chief Physician, Fu Xing Hospital, Capital Medical University
ClinicalTrials.gov Identifier: NCT02726971     History of Changes
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
Keywords provided by Jun Guo, Fu Xing Hospital, Capital Medical University:
Intrauterine Adhesion
Oestrogen Artificial Periodic Therapy
Additional relevant MeSH terms:
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Gynatresia
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes
Genital Diseases, Female
Estradiol
 Estrogens
Dydrogesterone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Progestins