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NCT03697031
Impact of Blastocyst Morphological Development and Blastocoele Re-expansion on Pregnancy Outcome After Using REKOVELLE®
trial testing Follitropin Delta in Controlled Ovarian Stimulation in 362 participants. Terminated before completion.
31 December 2020
Quick facts
| Lead sponsor | Ferring Pharmaceuticals |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 362 |
| Start date | 1 September 2018 |
| Primary completion | 31 December 2020 |
| Estimated completion | 31 December 2020 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- Follitropin Delta — full drug profile →
Conditions studied
- Controlled Ovarian Stimulation — all drugs for Controlled Ovarian Stimulation →
Sponsor
Ferring Pharmaceuticals — full company profile →
Who can join
Adults 18 to 45, female only, with Controlled Ovarian Stimulation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this observational study is to examine the development and appearance of embryos before and after freezing following a single controlled ovarian stimulation cycle using REKOVELLE® (follitropin delta) as the recombinant follicular stimulating hormone (rFSH) for controlled ovarian stimulation. The primary objective of the study is to examine how specific factors of embryo development or appearance are related to the chance of becoming pregnant. The ovarian stimulation protocol with REKOVELLE®, a new rFSH prescribed for ovarian stimulation, is individualised with a dosing regimen that is based on two parameters: the body weight and the level of a hormone, the anti-Müllerian hormone, (AMH), a parameter used to predict how the ovaries will respond to the ovarian stimulation.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Pre-Vitrification and Post-Warming Variables of Vitrified-Warmed Blastocysts That Are Predictable for Implantation.
Gabrielsen A, Iversen LH, Fedder J, Eskildsen TV, et al · · 2023 · cited 4× · PMID 37835035 · DOI 10.3390/jcm12196389
Verify or expand the search:
- PubMed search for NCT03697031
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Follitropin Delta
Trials testing the same drug.
- NCT04503707 — Study to Assess the Design of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Inj · completed
- NCT04150861 — Rekovelle PK Trial in Chinese Women · Phase 1 · completed
- NCT03393780 — Study to Assess the Patterns of Use of REKOVELLE® in Naïve Women Undergoing In Vitro Fertilisation or Intracytoplasmic S · completed
Other Ferring Pharmaceuticals trials
Trials by the same sponsor.
- NCT07152730 — A Study to Measure Pharmacokinetic (PK) Concentrations of Gonadotropin-Releasing Hormone Delivered by the OmniPod Pump · Phase 1 · withdrawn
- NCT07029451 — To Investigate REKOVELLE in Chinese Women Undergoing Assisted Reproductive Technologies: Effectiveness, Safety, and Patt · recruiting
- NCT06668493 — Low-grade UTUC Treated With Nadofaragene Firadenovec Administered to Renal Pelvis · Phase 1, PHASE2 · recruiting
- NCT06545955 — A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in · Phase 3 · recruiting
- NCT06510374 — Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Can · Phase 3 · 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 NCT03697031 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ferring Pharmaceuticals
- Last refreshed: 12 December 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/NCT03697031.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing