Thymosin-α1 for Recurrent Implantation Failure

NCT07675980 | Recruiting Phase 2 DMC

• 2 other identifiers: FAKIH-2025-13DOH/ADHRTC/2026/345
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical trial evaluating the safety and efficacy of Thymosin-α1 (Tα1) as an adjunctive immunomodulatory therapy in women with unexplained recurrent implantation failure (RIF) undergoing IVF/ICSI cycles.

Conditions

Recurrent Implantation Faliure

Keywords

Thymosin; recurrent implantation failure; Thymosin alpha; PGT-a tested embryos

Outcome Measures

Primary Outcomes (2)

• Live birth more than 24 weeks

  From date of randomization (luteal start ART) until end of intervention at 10 + 6 weeks and assessed up to live birth or miscarriage. Approximately 40 weeks.

  Approximately 40 weeks

• Determine whether Tα1 increases live birth versus placebo.

  Live birth (singleton or multiple)

  Approximately 40 weeks

Study Arms (2)

thymosin-α1

EXPERIMENTAL

Thymosin α1 in recurrent implantation failure patients

Drug: Thymosin Alpha1

Placebo

PLACEBO COMPARATOR

Placebo arm.

Other: Placebo Control

Interventions

Thymosin Alpha1 DRUG

Start at luteal start in ART cycles and continue until 10+6 weeks' gestation.

thymosin-α1

Placebo Control OTHER

Matching placebo injections on the same schedule and duration.

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Biological gender female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women 18-40 years
• RIF- ≥2 failed embryo transfers with PGT-a tested euploid embryos
• \- Normal parental karyotypes
• \- Normal uterine cavity on imaging
• \- Negative antiphospholipid panel
• \- Thyroid and prolactin controlled within local reference standards

You may not qualify if:

• Identified/correctable non-immune cause of RPL (chromosomal, anatomic, endocrine)
• \- Active malignancy
• Active infection
• \- Uncontrolled systemic disease
• \- Current systemic immunosuppression

Sponsors & Collaborators

• Fakih IVF Fertility Center: lead

Study Sites (1)

Fakih IVF

Abu Dhabi, United Arab Emirates

RECRUITING

Related Publications (10)

• Graham JJ, Longhi MS, Heneghan MA. T helper cell immunity in pregnancy and influence on autoimmune disease progression. J Autoimmun. 2021 Jul;121:102651. doi: 10.1016/j.jaut.2021.102651. Epub 2021 May 18.

  PMID: 34020252 BACKGROUND

• Dominari A, Hathaway Iii D, Pandav K, Matos W, Biswas S, Reddy G, Thevuthasan S, Khan MA, Mathew A, Makkar SS, Zaidi M, Fahem MMM, Beas R, Castaneda V, Paul T, Halpern J, Baralt D. Thymosin alpha 1: A comprehensive review of the literature. World J Virol. 2020 Dec 15;9(5):67-78. doi: 10.5501/wjv.v9.i5.67.

  PMID: 33362999 BACKGROUND

• Kaufmann RA, Welch RA, Mutchnick MG. Low periconceptional maternal serum thymosin alpha 1 levels are associated with blighted pregnancies. Am J Reprod Immunol. 1993 Apr;29(3):171-5. doi: 10.1111/j.1600-0897.1993.tb00583.x.

  PMID: 8373526 BACKGROUND

• Robertson SA. Immune tolerance in pregnancy. Nat Rev Immunol. 2020;20:67-82

  BACKGROUND

• Garaci E, Favalli C, Pica F, Sinibaldi Vallebona P, Palamara AT, Matteucci C, Pierimarchi P, Serafino A, Mastino A, Bistoni F, Romani L, Rasi G. Thymosin alpha 1: from bench to bedside. Ann N Y Acad Sci. 2007 Sep;1112:225-34. doi: 10.1196/annals.1415.044. Epub 2007 Jun 28.

  PMID: 17600290 BACKGROUND

• Lin, Y. et al. Maternal serum thymosin α1 and β4 levels in early pregnancy and risk of miscarriage. [Chinese study showing lower Tα1 in miscarriage]

  BACKGROUND

• Romani L, et al. Thymosin alpha-1: a safe and effective immune modulator in clinical practice. Expert Opin Biol Ther. 2016;16(5):691-707.

  BACKGROUND

• Goldstein AL, et al. Biological activities of thymosin alpha 1: clinical applications in disease modulation. Int Immunopharmacol. 2004;4(13):1781-1789.

  BACKGROUND

• Li J, et al. Case report: successful pregnancy following thymosin-α1 therapy in recurrent implantation failure. Pharm J. 2018.

  BACKGROUND

• Garofalo C, et al. Serum thymosin alpha-1 levels in early pregnancy and risk of miscarriage. Hum Reprod. 1992;7(9):1336-1339.

  BACKGROUND

MeSH Terms

Interventions

Thymalfasin

Intervention Hierarchy (Ancestors)

Thymosin; Thymus Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Proteins

Study Officials

• Michael Fakih, MD

  Fakih IVF Abu Dhabi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Lamiya Mohiyiddeen, MD, FRCOG

CONTACT

+971543676002; lamiya.mohiyiddeen@fakihivf.com

Fatma Bathawab, PhD

CONTACT

+971585707393; fatma.bathawab@fakihivf.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is double blind randomized controlled trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director, Research Ethics Committee Chair

Model Details: Thymosin alpha will be started during luteal phase of frozen embryo transfer cycle and continued till 12 weeks of pregnancy.

Study Record Dates

• First Submitted: June 9, 2026
• First Posted: June 30, 2026
• Study Start: February 11, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)