RAINBOW
Research type
Research Study
Full 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
IRAS ID
240567
Contact name
Khalaf Yacoub
Contact email
Sponsor organisation
Ferring Pharmaceuticals A/S
Eudract number
2017-003810-13
Duration of Study in the UK
2 years, 5 months, 7 days
Research summary
Around one in six couples may have difficulty in conceiving. Infertility is when a couple cannot conceive (get pregnant) despite having regular unprotected sex.
Conventional treatment involves harvesting multiple eggs and fertilising them in the laboratory before transfer to the womb (in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI)). Follicle stimulating hormones (FSH) are used to stimulate the ovaries to produce multiple eggs which in turn allows more eggs to be taken.
This trial is being conducted by the company Ferring Pharmaceuticals, who are developing a new drug under the scientific code name FE 999302. FE 999302 is thought to increase the quality of the eggs retrieved and thereby increase the chance of achieving pregnancy compared to standard treatment.
The main purpose of this clinical research trial is to learn about the efficiency and safety of different doses of FE 999302 when given together with REKOVELLE. The results of this trial will be used to select the optimal dose(s) for further clinical development of FE 999302
Lay summary of study results:-
At the doses investigated, the study demonstrated that the addition of HCG tp recombinant FSH did not improve ovarian response including the number of oocytes and blastocysts.
REC name
West of Scotland REC 1
REC reference
18/WS/0078
Date of REC Opinion
4 May 2018
REC opinion
Favourable Opinion