drugset / Trial / NCT01497197
A Trial to Compare the Efficacy and Safety of Ovarian Stimulation With GONAL-f® and Luveris® Starting on Day 1 Versus Day 6 in Women Undergoing Assisted Reproductive Technique
Phase 3
Terminated
174 enrolled
Merck KGaA, Darmstadt, Germany
Merck Serono Middle East FZ LLC · collab
RandomizedParallel-groupOpen-labelSupportive care
Summary
This is a phase IIIb, interventional, multicenter, multinational, randomised, open-label, comparative trial which primary objective is to generate data on the ovarian stimulation profile obtained when Luveris® is started either on Day 1 or Day 6 in women in advanced reproductive age (36-42) undergoing Assisted Reproductive Technique (ART).
Timeline
- Start
- 2012-05
- Primary completion
- 2014-01
- Completion
- 2014-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Luveris | Protein / enzyme biologic | 150 iu | Subcutaneous |
| Background | Gonal-f | Protein / enzyme biologic | 300 iu | Subcutaneous |
| Background | Ovidrel | Protein / enzyme biologic | 250 ug | — |