Comparison of Different Doses of Oestrogen Therapy for Preventing Intrauterine Adhesion

Fu Xing Hospital, Capital Medical University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Asherman Syndrome

Treatments: Drug: Femoston

Study type: Interventional

Funder types: Other

Identifiers

NCT02726971

LYuhuan

Details and patient eligibility

About

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.

Enrollment: 141 patients

Sex: Female

Ages: 25 to 45 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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141 participants in 2 patient groups

Low dose of oestrogen

Experimental group

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.

Treatment:

Drug: Femoston

High dose of oestrogen

Active Comparator group

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.

Treatment:

Drug: Femoston