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NCT01225835: PREDICT
Effect of Highly Purified Menotrophin and Recombinant Follicle Stimulating (rFSH, Follitrophin Alpha) in Subfertile Female Patients Undergoing IVF on Progesterone Serum Levels During the Follicular Phase and Their Possible Use as Predictors for the Success Rate of Ongoing Pregnancies
Phase 4 trial testing Menotrophin in Infertility in 124 participants. Completed in 1 June 2013.
1 January 2013
Quick facts
| Lead sponsor | Ferring Pharmaceuticals |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 124 |
| Start date | 1 October 2010 |
| Primary completion | 1 January 2013 |
| Estimated completion | 1 June 2013 |
| Sites | 8 locations across Germany |
Drugs / interventions tested
- Menotrophin — full drug profile →
- Follitrophin alpha
- Cetrorelix
- Choriongonadotropin — full drug profile →
- Progesterone (Progesterone plus HCG) — full drug profile →
Conditions studied
- Infertility — all drugs for Infertility →
Sponsor
Ferring Pharmaceuticals — full company profile →
Who can join
Adults 34 to 42, female only, with Infertility. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Serum Progesterone (P4) Level in the Morning of the Day of Human Chorionic Gonadotrophin (hCG) Administration
Time frame: approximately day 10
Ovulation induction was performed by administration of hCG once three follicles \>=17 mm diameter as shown by pelvic ultrasound examination. This outcome compares the serum progesterone level the morning prior to hCG administration across treatment arm, and also by age stratum (\<39 years and \>=39 years).
Sponsor's own description
This study is aimed to demonstrate that highly purified Menotrophin produces significant lower progesterone serum levels during the follicular phase in comparison to Follitropin alpha in the treatment of subfertile females undergoing an in vitro fertilisation (IVF) and to investigate if the progesterone serum levels might be a useful predictor for the success rate of the ongoing pregnancy rates
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 NCT01225835
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Infertility
Currently open trials in the same condition.
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- 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 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 NCT01225835 (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 Ferring Pharmaceuticals
- Last refreshed: 17 February 2014
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/NCT01225835.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing