Mode
Home
Research
Clinical Trials Drug Pipeline Weekly Digests
Reference
Conditions Medications
Community
Questions
Text Size
Log in / Sign up
Phase 2 N=265 Randomized Single-blind Treatment

A Dose-response Trial Using rFSH FE 999049 in Women Undergoing IVF/ICSI Treatment

Infertility

Bottom Line

View on ClinicalTrials.gov: NCT01426386 ↗
Enrolled (actual)
265
Serious AEs
0.4%
Results posted
Aug 2018
Primary outcome: Primary: Number of Oocytes Retrieved — 5.2; 7.9; 9.2; 10.5 Oocytes — p=<0.001

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
FE 999049 (Drug); Gonal - F (Drug)
Age
Adult · 18+ yrs
Sex
Female
Sponsor
Ferring Pharmaceuticals
Primary completion
Apr 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Oocytes Retrieved		 5.2; 7.9; 9.2; 10.5; 12.2; 10.4 <0.001 sig
SECONDARY
Number and Size of Follicles During Stimulation		 19.2; 23.0; 25.0; 27.9; 28.2; 26.7 <0.001 sig
SECONDARY
Endocrine Profile		 3641.9; 5221.1; 5689.5; 6171.8; 6442.0; 5750.7 <0.001 sig
SECONDARY
Total IMP Dose		 50.0; 61.9; 71.9; 81.0; 97.8; 94.7 —
SECONDARY
Number of Fertilised Oocytes		 3.7; 5.4; 4.9; 6.1; 6.7; 6.4 <0.001 sig
SECONDARY
Number and Quality of Blastocysts on Day 5		 2.3; 3.1; 2.7; 2.8; 3.2; 3.5 —
SECONDARY
Clinical Pregnancy With Fetal Heart Beat Rate		 36; 40; 36; 25; 40; 51 0.248
SECONDARY
Frequency and Intensity of Adverse Events		 15; 17; 17; 18; 15; 11 —

Summary

This trial investigates the effects of several doses of FE 999049 in women undergoing IVF/ICSI (in-vitro fertilisation/intracytoplasmic sperm injection) treatment.

Eligibility Criteria

Inclusion Criteria

  • Women diagnosed with tubal infertility, unexplained infertility, infertility related to endometriosis stage I/II or with partners diagnosed with male factor infertility
  • Women eligible for IVF (in-vitro fertilisation) and/or ICSI (intracytoplasmic sperm injection) treatment
  • Women aged 18-37 years
  • Women with body mass index (BMI) of 18.5-32.0 kg/m2

Exclusion Criteria

  • Women with polycystic ovary syndrome (PCOS) associated with anovulation, endometriosis stage III/IV
  • Women with history of recurrent miscarriage
  • Women with contraindications to controlled ovarian stimulation with gonadotropins
  • Women with three or more controlled ovarian stimulation cycles
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01426386). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search