CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 80 enrolled
Drug / intervention
Menotrophin +1 moredrug
Likely dose
150 IU daily subcutaneous injection for maximum 13 days; reduced to 75 IU daily if hyperstimulation occurs (both menotrophin and follitropin alfa)AI-extracted
Key inclusion· 13
  • ✓Subfertile premenopausal female patients eligible for IVF treatment
  • ✓Age 20–35 years
  • ✓BMI >18 and <32 kg/m²
  • ✓Normal endocrine assessment within the last 6 months
Key exclusion· 13
  • ✕Clinically relevant systemic disease (e.g., insulin-dependent diabetes mellitus)
  • ✕History of or current endocrine disease, including polycystic ovary-like syndrome and hyperprolactinemia
  • ✕History of coagulation disorders
  • ✕Persistent ovarian cysts

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00257556
NCT00257556Phase 4Completed
CompareCT.gov

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

Ferring Pharmaceuticals·interventional·Posted Nov 23, 2005·Updated Feb 26, 2010

In Brief

A Phase 4 clinical trial evaluating Menotrophin and Follitropin alfa for Infertility. Completed, enrolled 80 participants across 6 sites in 2 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfertility
CountriesGermany, United Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 23, 2005
Enrollment StartOct 1, 2005
Primary CompletionJul 1, 2008
Study CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 20.6 years ago

Interventions

Menotrophindrug

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.

Follitropin alfadrug

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.