Thymosin-α1 for Recurrent Implantation Failure
ConditionRecurrent Implantation Faliure
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorFakih IVF Fertility Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
-Women 18-40 years
-RIF- ≥2 failed embryo transfers with PGT-a tested euploid embryos
- Normal parental karyotypes
- Normal uterine cavity on imaging
Disqualifiers
Identified/correctable non-immune cause of RPL (chromosomal, anatomic, endocrine)
- Active malignancy
-Active infection
- Uncontrolled systemic disease
Trial design
Design model
Parallel
Treatments tested in this trial
Thymosin Alpha1
DrugStart at luteal start in ART cycles and continue until 10+6 weeks' gestation.
Placebo Control
Other interventionMatching placebo injections on the same schedule and duration.
Treatment groups
136 Participants
are divided into 2 treatment groupsGroup A: thymosin-α1Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Approximately 40 weeks2
Determine whether Tα1 increases live birth versus placebo.
Live birth (singleton or multiple)
Time frame
Approximately 40 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov