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NCT06641440
Treatment With Prednisone of Women With RPL or RIF Positive to Antithyroid Antibodies and Embryotoxicity Test
Phase 4 trial testing Prednisone in Recurrent Pregnancy Loss, Not Pregnant in 42 participants. Completed in 10 October 2024.
30 December 2023
Quick facts
| Lead sponsor | Centre for Endocrinology and Reproductive Medicine, Italy |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 42 |
| Start date | 1 January 2018 |
| Primary completion | 30 December 2023 |
| Estimated completion | 10 October 2024 |
| Sites | 2 locations across Italy |
Drugs / interventions tested
- Prednisone (prednisone) — full drug profile →
Conditions studied
- Recurrent Pregnancy Loss, Not Pregnant — all drugs for Recurrent Pregnancy Loss, Not Pregnant →
- Recurrent Implantation Failure — all drugs for Recurrent Implantation Failure →
Sponsor
Centre for Endocrinology and Reproductive Medicine, Italy — full company profile →
Who can join
Adults 20 to 39, female only, with Recurrent Pregnancy Loss, Not Pregnant or Recurrent Implantation Failure. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In Reproductive Medicine there is a unresolved question, whether thyroid autoimmunity may promote infertility, embryo demise and miscarriage. A study was conducted in order to evaluate which treatment is more effective in women with recurrent pregnancy loss (RPL) or recurrent implantation failure (RIF) and positivity to anti-thyroid antibodies to improve their livebirth rate. The patients were treated with prednisone plus levothyroxine in the study group, whereas in the control group the women were treated only with levothyroxine. The patients were treated at least three months before to try again to remain pregnant in case of RPL or to undergo to another embryo transfer with a single blastocyst in case of RIF. The patients during treatment and during the eventual pregnancy will followed up with beta-HCG, anti-thyroid antibodies and TSH levels, as well as ultrasound scan to evaluate the embryo growth and its wellbeing. A statistical analysis will be performed to determine the levels of significance for the parameters evaluated.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06641440
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06641440 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Centre for Endocrinology and Reproductive Medicine, Italy
- Last refreshed: 16 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06641440.
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