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Comparison of Different Doses of Oestrogen Therapy for Preventing Intrauterine Adhesion

Primary Purpose

Asherman Syndrome

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Femoston
Sponsored by
Fu Xing Hospital, Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asherman Syndrome focused on measuring Intrauterine Adhesion, Oestrogen Artificial Periodic Therapy

Eligibility Criteria

25 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Fu Xing Hospital,Capital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low dose of oestrogen

High dose of oestrogen

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 22, 2016
Last Updated
April 6, 2017
Sponsor
Fu Xing Hospital, Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02726971
Brief Title
Comparison of Different Doses of Oestrogen Therapy for Preventing Intrauterine Adhesion
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 Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fu Xing Hospital, Capital Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asherman Syndrome
Keywords
Intrauterine Adhesion, Oestrogen Artificial Periodic Therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
141 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low dose of oestrogen
Arm Type
Experimental
Arm Description
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.
Arm Title
High dose of oestrogen
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Femoston
Intervention Description
Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone.
Primary Outcome Measure Information:
Title
the AFS Score at Second-look Hysteroscopy
Description
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
Secondary Outcome Measure Information:
Title
the AFS Score at Third-look Hysteroscopy
Description
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
Title
Participants With Improvement of Menstrual Pattern at Third-look Hysteroscopy
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Fu Xing Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100038
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Comparison of Different Doses of Oestrogen Therapy for Preventing Intrauterine Adhesion

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