Ex Vivo Gamma Globulin Therapy for Infertile Women with Anticentromere Autoantibodies

Ex Vivo Gamma Globulin Therapy for Infertile Women with Anticentromere Autoantibodies: A Single-Arm, Historically Controlled Cohort Study - EVITA study Ex VIvo gamma globulin therapy for infertile women with anTicentromere Autoantibodies

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000058969

Enrollment

Registered

2025-09-10

Start date

2022-07-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anticentromere autoantibody-related female infertility

Interventions

Ex vivo gamma globulin supplementation to culture media

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Women diagnosed with infertility who desire to conceive. Positive for anticentromere antibody (titer 1:640 or higher).

Exclusion criteria

Exclusion criteria: History of clinical pregnancy. History, signs, or symptoms suggestive of autoimmune diseases.

Design outcomes

Primary

Measure	Time frame
Good-quality blastocyst formation rate Live birth rate	—

Countries

Japan

Contacts

Public ContactMakio Shozu

Natural ART Clinic at Nihonbashi Clinical Laboratory

mail@naturalart.or.jp03-6262-5757

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026