Trials / Completed
CompletedNCT01110707
A Randomised, Phase II, Comparative Study With a Parallel Control for Evaluating the Efficacy and Safety of Combined Treatment of Lutropin Alpha and Recombinant Human Luteinizing Hormone in the Middle of the Controlled Ovarian Stimulation Follicular Phase in Women With Reduced Ovarian Reserve
Lutropin Alpha in the Middle of the Controlled Ovarian Stimulation Follicular Phase in Women With Reduced Ovarian Reserve: Comparative Study, in Phase II, With Parallel Control
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 131 (actual)
- Sponsor
- Merck KGaA, Darmstadt, Germany · Industry
- Sex
- Female
- Age
- 35 Years – 40 Years
- Healthy volunteers
- Not accepted
Summary
This was a prospective, randomized, Phase II, comparative study with a parallel control for evaluating the efficacy and safety of combined treatment of recombinant human follicle stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH). The combined treatment was administered at the middle of the follicular phase in subjects undergoing in-vitro fertilisation (IVF) through intracytoplasmic sperm injection (ICSI) and transfer of embryos (ET).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Recombinant human follicle stimulating hormone (r-hFSH) | Subjects will receive subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day \[mg/day\]). |
| DRUG | Recombinant human luteinizing hormone (r-hLH) | Subjects will receive subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation. |
Timeline
- Start date
- 2005-01-10
- Primary completion
- 2006-11-15
- Completion
- 2006-11-15
- First posted
- 2010-04-27
- Last updated
- 2018-03-27
- Results posted
- 2018-03-27
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT01110707. Inclusion in this directory is not an endorsement.