NCT00257556

A Study of the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant Follitropin Alfa

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Female
• Age: 20 Years – 35 Years
• Healthy volunteers: Accepted

Summary

Prospective open label, randomised, parallel group, comparative pilot.

Detailed description

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.

Conditions

• Infertility

Interventions

Type	Name	Description
DRUG	Menotrophin	150 IU Menotrophin daily subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily.
DRUG	Follitropin alfa	150 IU follitropin alfa daily by subcutaneous injection for a maximum of 13 days. In the event of hyperstimulation, the dose was reduced to 75 IU daily.

Timeline

• Start date: 2005-10-01
• Primary completion: 2008-07-01
• Completion: 2009-04-01
• First posted: 2005-11-23
• Last updated: 2010-02-26
• Results posted: 2010-02-26

Locations

6 sites across 2 countries: Germany, United Kingdom