A Trial to Investigate the Efficacy and Safety of FE 999302 as add-on Treatment to Follitropin Delta (REKOVELLE) in Women Undergoing Controlled Ovarian Stimulation. — RAINBOW

Controlled Ovarian Stimulation Clinical Trial

Official title:
A Randomised, Double-blind, Placebo-controlled, Parallel-group, Dose-range Trial to Investigate the Efficacy and Safety of FE 999302 as add-on Treatment to Follitropin Delta (REKOVELLE) in Women Undergoing Controlled Ovarian Stimulation in a Long GnRH Agonist Protocol

Status Completed

Clinical Trial Summary

The purpose of this phase 2 dose-ranging trial is to investigate the effects of FE 999302 on parameters influencing pregnancy rates in women undergoing Controlled Ovarian Stimulation (COS) with follitropin delta in a long gonadotropin releasing hormone (GnRH) agonist protocol. Furthermore, the study intends: - To investigate the safety of FE 999302 in women undergoing COS with follitropin delta in a long GnRH agonist protocol. - To investigate the potential immunogenicity of FE 999302 in subjects undergoing COS with follitropin delta in a long GnRH agonist protocol. - To estimate the impact of body weight on FE 999302 exposure in subjects undergoing COS with follitropin delta in a long GnRH agonist protocol.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Controlled Ovarian Stimulation

Clinical Trial Details

NCT number	NCT03564509
Study type	Interventional
Source	Ferring Pharmaceuticals
Contact
Status	Completed
Phase	Phase 2
Start date	May 14, 2018
Completion date	January 8, 2020

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04122729` - N680S Polymorphism of the FSHR Gene and Its Relationship With the Type of Gonadotropin Used in COS
Terminated	`NCT03697031` - Impact of Blastocyst Morphological Development and Blastocoele Re-expansion on Pregnancy Outcome After Using REKOVELLE®
Completed	`NCT03051087` - To Compare and Evaluate the Efficacy and Safety of Ganilever PFS(Prefilled Syringe) and Orgalutran®	Phase 4
Completed	`NCT01339299` - Study to Examine Effect of Recombinant Luteinizing Hormone (r-Lh) and Recombinant Human Chorionic Gonadotropin (r-hCG) for Ovarian Stimulation in Assisted Reproduction Techniques (ART)	Phase 4
Completed	`NCT03366025` - Progesterone Variation on the Final Day of Oocyte Maturation.
Completed	`NCT00725491` - A Study to Assess the Efficacy and Safety of Ganirelix (Orgalutran®) Treatment in Chinese Women Undergoing Controlled Ovarian Stimulation for in Vitro Fertilization (IVF) or Intra Cytoplasmatic Sperm Injection (ICSI) (Study 38651)(P05703)	Phase 3
Completed	`NCT03393780` - Study to Assess the Patterns of Use of REKOVELLE® in Naïve Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures
Completed	`NCT04503707` - Study to Assess the Design of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures in Routine Clinical Practice
Withdrawn	`NCT01510054` - Endometrial Luteal Phase Characteristics and Luteal Phase Support in Controlled Ovarian Stimulation Protocols With GnRH Antagonists:Focusing on MicroRNA	N/A
Completed	`NCT00988260` - Japanese Bridging Trial of Org 37462 (Study P05969)(COMPLETED)	Phase 2
Completed	`NCT05499052` - Trial to Assess the Pattern of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation (IVF) or Intracytoplasmic Sperm Injection (ICSI) Procedures in Routine Clinical Practice