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A multi-hospital study to test the right dose and safety of Thymosin alpha one in women with repeated IVF failures or miscarriages

A prospective multiple center dose determination study to evaluate the efficacy and safety of Thymosin alpha one as an adjuvant therapy to standard of care (SOC) in patients with recurrent implantation failure and recurrent pregnancy loss - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/04/085688
Enrollment
56
Registered
2025-04-25
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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

Conditions

Health Condition 1: N979- Female infertility, unspecified

Interventions

Intervention1: Thymosin alpha one: Study participant has been administered a thymosin alpha-1 injection until Embryo transfer, dose determined by randomization Control Intervention1: Not applicable: N

Sponsors

Aruna R
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Failure of clinical pregnancy after 4 good quality embryo transfers, with at least three fresh or frozen IVF cycles, and in women under the age of 40 Two or more consecutive failed clinical pregnancies documented by ultrasound or histopathology Female participants who are willing to provide a voluntary written informed consent.

Exclusion criteria

Exclusion criteria: Female participants who have participated in another trial with an investigational drug within 1 month prior to this trial. Female participants who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol. Female participants with a history of any clinically significant illness, in the opinion of the investigator, that may jeopardize the study results.

Design outcomes

Primary

MeasureTime frame
Implantation rateTimepoint: 6 weeks

Secondary

MeasureTime frame
Ongoing pregnancy rateTimepoint: 12 weeks of pregnancy

Countries

India

Contacts

Public ContactDr Aruna R

A4 Hospital and Fertility centre Pvt Ltd

aruna@a4fertility.com09841269578

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026