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Sponsored by: |
Ferring Pharmaceuticals |
Information provided by: | Ferring Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00257556 |
Prospective open label, randomised, parallel group, comparative pilot.
Condition | Intervention | Phase |
Infertility |
Drug: Menotrophin Drug: Recombinant FSH (Follitropin alfa) |
Phase IV |
MedlinePlus related topics: | Infertility |
ChemIDplus related topics: | Follitropin beta Urofollitropin Follicle Stimulating Hormone Menotropins |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Prospective, Open Label, Randomised, Parallel Group, Comparative Pilot Study to Study the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant FSH (Follitropin Alfa) Administered Subcutaneously to Subfertile Female Patients Undergoing IVF Using Antagonist Downregulation |
Estimated Enrollment: | 72 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental |
Drug: Recombinant FSH (Follitropin alfa)
150iu gonadotrophin daily for a maximum of 13 days
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2: Active Comparator |
Drug: Menotrophin
150iu gonadotrophin daily for a maximum of 13 days
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Ongoing pregnancy rate, defined as positive fetal heart action 9 weeks after the first positive pregnancy test. Number/diameter of follicles, number of oocytes retrieved, number of pronuclear oocytes (referred to as zygotes or pre-embryos in the UK, quality of pronuclear stage oocytes, number of embryos transferred, quality of embryos, number of frozen embryos, endometrial thickness and morphology on day of HCG administration, estradiol levels at day of HCG administration, implantation rate, number of days stimulated with gonadotrophins and number of ampoules used, clinical pregnancy rate at 6 weeks after the first positive pregnancy test, pregnancy outcome
Ages Eligible for Study: | 20 Years to 35 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Female patients aged > or = 20 and < or = 35 years with a BMI of >18 and <32 kg/m2 who have received no more than two previous cycles of IVF (or other ART) and whose partners have normal sperm (according to WHO 1999 criteria).
Inclusion criteria:
Exclusion criteria
Contact: Dr. Rebecca Elwin | 01753 214843 | rebecca.elwin@Ferring.Com |
Germany | |||||
Universitats-Frauenklinik Heidelberg Abt. Gynakologische Endokrinologie und Fertilitatsstorungen | Recruiting | ||||
Heidelberg, Germany, 69115 | |||||
Contact: Thomas Strowitzki, MD | |||||
Gemeinschaftspraxis und Tagesklinik | Recruiting | ||||
Hildesheim, Germany, 1134 | |||||
Contact: Georg Wilke, MD | |||||
Gemeinschaftspraxis und Tagesklinik | Recruiting | ||||
Dortmund, Germany, 44135 | |||||
Contact: Stefan Dieterle, MD | |||||
United Kingdom | |||||
Leeds General Infirmary | Recruiting | ||||
Leeds, United Kingdom | |||||
Contact: Anthony Rutherford, M.D. | |||||
The Royal Hallamshire Hospital | Recruiting | ||||
Sheffield, United Kingdom | |||||
Contact: William Ledger, MD |
Ferring Pharmaceuticals |
Study Director: | Dr. Rebecca Elwin | Ferring UK |
Responsible Party: | Ferring UK ( Rebecca Elwin, Medical Advisor ) |
Study ID Numbers: | FE999906 CS004 (PROSPECT) |
First Received: | November 22, 2005 |
Last Updated: | August 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00257556 |
Health Authority: | United Kingdom: National Health Service |
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