Comparison of Different Doses of Oestrogen Therapy for Preventing Intrauterine Adhesion

A Prospective, Randomized, Controlled Trial Comparing 2 Different Doses of Estrogen Therapy After Hysteroscopic Adhesiolysis as an Adjuvant to Prevent Recurrence of Intrauterine Adhesions

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.

Study Overview

• Status: Completed
• Conditions: Asherman Syndrome
• Intervention / Treatment: Drug: Femoston

• Study Type: Interventional
• Enrollment (Actual): 141
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100038
      • Fu Xing Hospital,Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Fu Xing Hospital, Capital Medical University

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: March 22, 2016
• First Submitted That Met QC Criteria: March 29, 2016
• First Posted (Estimate): April 4, 2016

Study Record Updates

• Last Update Posted (Actual): April 10, 2017
• Last Update Submitted That Met QC Criteria: April 6, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Intrauterine Adhesion; Oestrogen Artificial Periodic Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions; Gynatresia
• Other Study ID Numbers: LYuhuan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No