Last reviewed · How we verify
NCT05638529
Dual Trigger" in IVF Patients at High Risk of Ovarian Hyper Stimulation Syndrome
Phase 4 trial testing Pregnyl (1,500) IU in Ovarian Hyperstimulation Syndrome in 80 participants. Status unknown.
31 December 2023
Quick facts
| Lead sponsor | Mount Sinai Hospital, Canada |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 1 May 2019 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Pregnyl (1,500) IU — full drug profile →
- 1.5 mL of normal saline — full drug profile →
Conditions studied
- Ovarian Hyperstimulation Syndrome — all drugs for Ovarian Hyperstimulation Syndrome →
- Infertility, Female — all drugs for Infertility, Female →
Sponsor
Mount Sinai Hospital, Canada
Who can join
Adults 18 to 40, female only, with Ovarian Hyperstimulation Syndrome or Infertility, Female. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The present study aims to evaluate whether the use of a "dual trigger" can improve IVF outcomes, compared to GnRH agonist (GnRH-a) alone, in patients at high risk of OHSS undergoing a freeze-all cycle. By examining freeze-all cycles with frozen embryo transfer(s) (FET) only, we eliminate the potential confounding issue of inadequate luteal support to the endometrium and focus primarily on the effect of a "dual trigger" on oocyte quality and embryo potential. To our best knowledge, there have been no randomized, controlled trials conducted to address this hypothesis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05638529
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Mount Sinai Hospital, Canada trials
Trials by the same sponsor.
- NCT07272460 — Time Restricted-EAting for Type 2 Diabetes and MEtabolic Health: the TEA TIME Trial · NA · recruiting
- NCT07046572 — Methoxyflurane for IUD Insertion and Endometrial Biopsy · NA · recruiting
- NCT06504277 — Low Versus Standard Pressure Pneumoperitoneum on Shoulder Tip Pain · NA · recruiting
- NCT06546254 — 1% Lidocaine Paracervical Block for Endometrial Biopsy · NA · completed
- NCT06733701 — The Use of Virtual Reality Technology During Oocyte Retrieval for in Vitro Fertilization · NA · 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 NCT05638529 (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 Mount Sinai Hospital, Canada
- Last refreshed: 3 July 2023
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/NCT05638529.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing