Evaluation of Safety and Cytokine Modulation Following TNF-alpha Inhibitor Administration in Patients with Refractory Recurrent Pregnancy Loss

Open-Label, Non-Controlled Study Evaluating Cytokine Profiles, Safety, and Exploratory Efficacy of TNF-alpha Inhibitor Therapy in Patients with Refractory Recurrent Pregnancy Loss

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs041250083

Enrollment

Registered

2025-08-25

Start date

2025-08-25

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

refractory recurrent pregnancy loss refractory recurrent pregnancy loss, TNF-alpha Inhibitors

Interventions

Adalimumab 40 mg is administered subcutaneously every two weeks. For cases with a history of recurrent early miscarriage (previous miscarriages occurring before 10 weeks of gestation), administration

Adalimumab

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) A history of five or more miscarriages 2) At least one miscarriage with a normal karyotype diagnosed by chorionic chromosomal (genetic) testing 3) In patients diagnosed with antiphospholipid syndrome, at least one miscarriage with a normal fetal karyotype despite receiving standard therapy (low-dose aspirin and unfractionated heparin from early pregnancy). 4) Age between 20 and 46 years at the time of consent 5) Written informed consent obtained from the patient regarding participation in this study

Exclusion criteria

Exclusion criteria: 1) Having one or more live births. 2) Either partner has a chromosomal abnormality. 3) Presence of evident uterine structural abnormalities. 4) Presence of serious infections, active tuberculosis, demyelinating disease, or congestive heart failure. 5) Currently participating in another clinical trial or interventional clinical study. 6) Presence of active hepatitis B, hepatitis C, or tuberculosis. Participation is permitted if the disease is inactive and the patient agrees to undergo regular monitoring (approximately every 1-3 months) for reactivation. 7) Deemed unsuitable for study participation by the principal or sub-investigator for any other reason.

Design outcomes

Primary

Measure	Time frame
Change in serum TNF-alpha levels	—

Secondary

Measure	Time frame
1) Live birth rate 2) Pregnancy continution rate at 22 weeks of gestation 3) Pregnancy outcommes including pregnancy complications, delivery complications and neonatel information 4) Presence of developmental abnormalities and incidence of infections inthe infant up to 6 months of age 5) Changes and change rates in the following laboratory parameteres as follows; White blood cell count, CRP, TNF-alpha in cervical mucus, IL-6 in serum and cervical mucus	—

Measure

Time frame

1) Live birth rate 2) Pregnancy continution rate at 22 weeks of gestation 3) Pregnancy outcommes including pregnancy complications, delivery complications and neonatel information 4) Presence of developmental abnormalities and incidence of infections inthe infant up to 6 months of age 5) Changes and change rates in the following laboratory parameteres as follows; White blood cell count, CRP, TNF-alpha in cervical mucus, IL-6 in serum and cervical mucus

—

Contacts

Public ContactTamao Kitaori

Nagoya City University Hospital

tama-og@med.nagoya-cu.ac.jp+81-52-853-8241

Outcome results

None listed

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