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NCT04695483: PE-PMA
Reduction of Progesterone Elevation at Trigger in POR After Long Acting COS Compared With Daily COS: a Prospective Randomized Trial
Phase 4 trial testing Corifollitropin alfa in Infertility in 110 participants. Completed in 6 May 2024.
19 January 2024
Quick facts
| Lead sponsor | IRCCS San Raffaele |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 110 |
| Start date | 22 February 2022 |
| Primary completion | 19 January 2024 |
| Estimated completion | 6 May 2024 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Corifollitropin alfa (CORIFOLLITROPIN ALFA) — full drug profile →
- Follitropin Beta — full drug profile →
Conditions studied
- Infertility — all drugs for Infertility →
Sponsor
IRCCS San Raffaele — full company profile →
Who can join
Adults 25 to 42, female only, with Infertility. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The overarching objective of this research is to generate clinical evidence to argue the benefits of long acting stimulation protocol compared to the daily stimulation protocol in poor ovarian responder bologna' criteria patients after controlled ovarian stimulation. Reduction in the proportion of subjects with progesterone \> 1.1 ng/ml on the day of triggering (day + 13) in the experimental group compared to the control group is expected.
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 NCT04695483
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Corifollitropin alfa
Trials testing the same drug.
- NCT04482751 — The Relationship Between Serum AMH Dynamics and Early or Normal Ovarian Response to Corifollitropin Alfa · unknown
- NCT03019575 — Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (hCG) in Adolesce · Phase 3 · completed
- NCT01709331 — A Study of the Efficacy and Safety of Corifollitropin Alfa (MK-8962) in Combination With Human Chorionic Gonadotropin (h · Phase 3 · completed
- NCT01146418 — Frozen-thawed Embryo Transfer (FTET) Cycle Follow-up Protocol (P06031) · Phase 3 · completed
- NCT00702234 — Pregnancy and Neonatal Follow-up of Ongoing Pregnancies Established in Clinical Trial P05714 (Care Program)(P05715) · completed
Other recruiting trials for Infertility
Currently open trials in the same condition.
- NCT07074015 — IntelliWell: An AI-Assisted Imaging Platform for Detection and Location of Ultra-Rare Testicular Sperm in Surgical Speci · NA · recruiting
- NCT07358468 — Impact Of FET Preparation Protocol On Endometrial Peristalsis: A Prospective Cohort Study · recruiting
- NCT07340827 — A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH · Phase 3 · recruiting
- NCT07369362 — To Investigate if the Harvester® Improves Sperm Motility and Blastocyst Utilization (the Percent of Fertilized Eggs That · NA · active not recruiting
- NCT07153367 — Using a Fixed Dosage of Follitropin Delta for Ovarian Stimulation for Intrauterine Insemination: Rekovelle for Intrauter · Phase 2 · recruiting
Other IRCCS San Raffaele trials
Trials by the same sponsor.
- NCT07454759 — Acute Sarcopenia in Hospitalized Older Adults · not yet recruiting
- NCT07456462 — Making Antibody Treatments More Effective in Early Alzheimer's Disease Using 3Tesla Magnetica Resonance · NA · not yet recruiting
- NCT07066878 — This Protocol Focuses on the Factors That Influence Survival, the Development of Complications and the Quality of Life B · not yet recruiting
- NCT07526298 — Anticipating Irreversible Disability in Neuromyelitis Optica Spectrum Disorder: a Study to Assess Disease Activity in Ap · not yet recruiting
- NCT07426471 — Delafloxacin Plasma and Tissue Concentration in Patients With Skin, Soft Tissue, and Bone and Joint Infections. · not yet recruiting
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 NCT04695483 (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 IRCCS San Raffaele
- Last refreshed: 16 May 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/NCT04695483.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing