A study of the efficacy of a temporary insertion of intrauterine silicone plate for preventing intrauterine adhesion after hysteroscopic surgery.

JRCT ID: jRCTs072180074

Registered date:22/03/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Intrauterine Adhesion (Asherman syndrome), Uterine septum
• Date of first enrollment: 23/03/2016
• Target sample size: 15
• Study type: Interventional
• Intervention(s): Insertion of intrauterine silicone plate.

Outcome(s)

• Primary Outcome: Intrauterine adhesion rate after one year following hysteroscopic surgery for preventing intrauterine adhesion.

Secondary Outcome

Intrauterine adhesion rate after two months following hysteroscopic surgery for preventing intrauterine adhesion.
Pregnancy rate after one year following hysterscopic surgery for preventing intrauterine adhesion.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 49age old
• Gender: Female

Include criteria

1.Intrauterine adhesion(Asherman syndrome),Uterine septum
2. Infertility or Recurrent pregnancy loss
3.Patients who plan to undergo hysteroscopic adhesiolysis or hysteroscopic uterine septum resection
4.Patients who are informed consent about participation in this study and received written consent.

Exclude criteria

1.Women who don't desire to conceive
2.Patients with severe immunocompromised state

Related Information

• Primary Sponsor: Mekaru Keiko
• Secondary ID(s): UMIN000022490