Comparing the Efficacy of Two Methods for the Therapy of Uterine Adhesion

NCT03329898 | Unknown DMC

• 1 other identifier: No.4-20171020
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. The recurrence of intrauterine adhesions is a major challenge in clinical practice. It has been reported that dried biological aminion graft was used to prevent adhesion after the operation of intrauterine adhesions. Intrauterine balloon can reduce the recurrence of adhesions after operation. Does the combination of balloon and amniotic products can improve clinical outcomes? Therefore, this study was conducted.

Conditions

Intrauterine Adhesion

Keywords

Asherman syndrome; uterine stent; hysteroscopy

Outcome Measures

Primary Outcomes (1)

• second diagnostic hysteroscopy

  American fertility society score ,Scores of 1-4, 5-8, and 9-12 were considered to represent mild, moderate, and severe adhesions, respectively

  postoperation three months

Secondary Outcomes (3)

• pregnancy

  postoperation one year

• Menstruation Pattern

  postoperation three months

• adhesion reformation

  postoperation three months

Study Arms (2)

dried biological amnion graft

EXPERIMENTAL

dried biological amnion graft patients, who are with IUA, treated by uterine application of dried biological amnion graft + disposable balloon uterine stent + hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.

Procedure: dried biological amnion graft; Device: disposable balloon uterine stent; Drug: estradiol valerate tablets; Drug: dydrogesterone Tablets

disposable balloon uterine stent only

SHAM COMPARATOR

disposable balloon uterine stent patients, who are with IUA, treated by uterine application of disposable balloon uterine stent only + hormones (estradiol valerate tablets+dydrogesterone Tablets) following hysteroscopic adhesiolysis.

Device: disposable balloon uterine stent; Drug: estradiol valerate tablets; Drug: dydrogesterone Tablets

Interventions

dried biological amnion graft PROCEDURE

dried biological amnion graft. The amnion grafts were spread on the balloon end of disposable balloon uterine stent .

Also known as: uterine application of amnion membrance

dried biological amnion graft

disposable balloon uterine stent DEVICE

the disposable balloon uterine stent is heart-shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus.

disposable balloon uterine stent only; dried biological amnion graft

estradiol valerate tablets DRUG

oral estradiol valerate tablets, which can promote endometrial growth after operation.

Also known as: Progynova

disposable balloon uterine stent only; dried biological amnion graft

dydrogesterone Tablets DRUG

oral dydrogesterone Tablets

Also known as: Duphaston

disposable balloon uterine stent only; dried biological amnion graft

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• age 20-45 years.
• previously diagnostic hysteroscopy confirmed adhesion score ≧5， according to the American Fertility Society (AFS).
• complains of menstruation disorder and reproductive dysfunction.
• informed consent.

You may not qualify if:

• premature menopause,
• presence of other intrauterine lesions (e.g. polyps, myoma, septa), and
• presence of severe intercurrent illness (e.g. systemic disease, coagulative disorders, severe kidney and liver diseases),
• adhesions limited to the lower uterine cavity or the cervical canal.

Sponsors & Collaborators

• Beijing Obstetrics and Gynecology Hospital: lead

Study Sites (1)

Beijing Obstetrics and Gynecology Hospital, Capital Medical University

Beijing, China

RECRUITING

MeSH Terms

Conditions

Gynatresia

Interventions

Estradiol; Dydrogesterone

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pregnadienes; Pregnanes

Study Officials

• Duan Hua, PhD

  Beijing Obstetrics and Gynecology Hospital

  STUDY CHAIR

Central Study Contacts

Zhu Ru, MD

CONTACT

13966636438; zhuru19790202@163.com

Wang Sha, PhD

CONTACT

15201556908; wangsha1020@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: November 6, 2017
• Study Start: October 31, 2017
• Primary Completion: October 25, 2018
• Study Completion: November 25, 2018
• Last Updated: November 17, 2017

Record last verified: 2017-11

Locations

CN (1)