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
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
2 other identifiers
interventional
620
5 countries
20
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2018
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 14, 2018
CompletedFirst Submitted
Initial submission to the registry
May 16, 2018
CompletedFirst Posted
Study publicly available on registry
June 21, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 8, 2020
CompletedAugust 31, 2023
January 1, 2020
1.4 years
May 16, 2018
August 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of good-quality blastocysts on Day 5 after oocyte retrieval
Quality of blastocysts was assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring was based on the classification system by Gardner and Schoolcraft, with additional categories for inner cell mass (degenerative or no inner cell mass) and trophectoderm (degenerative or very large cell).
On Day 5 after oocyte retrieval
Secondary Outcomes (28)
Number of subjects with at least one good-quality blastocyst on Day 5 after oocyte retrieval
On Day 5 after oocyte retrieval
Number of subjects with at least two good-quality blastocysts on Day 5 after oocyte retrieval
On Day 5 after oocyte retrieval
Number and quality of embryos on Day 3 after oocyte retrieval
On Day 3 after oocyte retrieval
Number and quality of blastocysts on Day 5 after oocyte retrieval
On Day 5 after oocyte retrieval
Changes in serum hormone levels
Stimulation Day 1 (baseline), stimulation Day 6, stimulation Day 8, end-of-stimulation (up to 20 stimulation days), and oocyte retrieval
- +23 more secondary outcomes
Study Arms (6)
FE 999302 (1 μg) and follitropin delta
EXPERIMENTALFE 999302 (2 μg) and follitropin delta
EXPERIMENTALFE 999302 (4 μg) and follitropin delta
EXPERIMENTALFE 999302 (8 μg) and follitropin delta
EXPERIMENTALFE 999302 (12 μg) and follitropin delta
EXPERIMENTALPlacebo and follitropin delta
PLACEBO COMPARATORInterventions
Daily dose of 1 μg of FE 999302, a recombinant human chorionic gonadotropin (rhCG) solution for subcutaneous injection; individualized follitropin delta dose.
Daily dose of 2 μg of FE 999302, a rhCG solution for subcutaneous injection; individualized follitropin delta dose.
Daily dose of 4 μg of FE 999302, a rhCG solution for subcutaneous injection; individualized follitropin delta dose.
Daily dose of 8 μg of FE 999302, a rhCG solution for subcutaneous injection; individualized follitropin delta dose.
Daily dose of 12 μg of FE 999302, a rhCG solution for subcutaneous injection; individualized follitropin delta dose.
Daily dose of placebo; individualized follitropin delta dose.
Eligibility Criteria
You may qualify if:
- Informed consent documents signed prior to screening evaluations.
- In good physical and mental health as judged by the investigator.
- Anti-Müllerian hormone (AMH) levels at screening of 5.0-35.0 pmol/L (as measured by Elecsys® AMH Plus Immunoassay \[Roche Diagnostics\] at central laboratory).
- Pre-menopausal women between the ages of 30 and 42 years. The subjects must be at least 30 years (including the 30th birthday) and no more than 42 years (up to the day before the 43rd birthday) when they sign the informed consent.
- Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II or with partners diagnosed with male factor infertility, eligible for in vitro fertilisation and/or intracytoplasmic sperm injection using fresh or frozen ejaculated sperm from male partner or sperm donor.
- Infertility for at least 1 year before screening for subjects less than 35 years or for at least 6 months for subjects greater than equal to (≥)35 years (not applicable in case of tubal or severe male factor infertility).
You may not qualify if:
- Known polycystic ovary syndrome (PCOS) associated with anovulation or known endometriosis stage III-IV (defined by the revised American Society for Reproductive Medicine \[ASRM\] classification, 1996).
- One or more follicles ≥10 mm (including cysts) observed on the transvaginal ultrasound after down-regulation prior to randomisation on stimulation day 1 (puncture of cysts is allowed prior to randomisation).
- Pregnancy (negative pregnancy tests must be documented at screening and prior to start of down-regulation) or contraindication to pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Universitair Ziekenhuis Gent (UZ Gent)
Ghent, Belgium
Universitair Ziekenhuis Brussel
Jette, Belgium
Institut fur Reproduktionsmedizin und Genetik
Karlovy Vary, Czechia
Fertimed
Olomouc, Czechia
GYNEM
Prague, Czechia
IVF CUBE
Prague, Czechia
Aalborg University Hospital
Aalborg, Denmark
Rigshospitalet
Copenhagen, Denmark
Dansk Fertilitetsklinik
Frederiksberg, Denmark
Hvidovre Hospital
Hvidovre, Denmark
Dexeus Woman's Health
Barcelona, Spain
Instituto Valenciano de Infertilidad (IVI) - Bilbao
Leioa, Spain
GINEFIV - Clinica Belen Location
Madrid, Spain
Instituto Valenciano de Infertilidad (IVI) - Madrid
Madrid, Spain
Instituto Valenciano de Infertilidad (IVI) - Sevilla
Seville, Spain
Instituto Valenciano de Infertilidad (IVI) - Valencia
Valencia, Spain
Glasgow Royal Infirmary
Glasgow, United Kingdom
Liverpool Women's Hospital
Liverpool, United Kingdom
Guy's and St Thomas' NHS Trust
London, United Kingdom
Kings College (Assisted Conception Unit)
London, United Kingdom
Related Publications (1)
Sanchez MF, Larsson P, Serrano MF, Bosch E, Velasco JAG, Lopez ES, Mannaerts B. Live birth rates following individualized dosing algorithm of follitropin delta in a long GnRH agonist protocol. Reprod Biol Endocrinol. 2023 May 16;21(1):45. doi: 10.1186/s12958-023-01090-w.
PMID: 37194068RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Compliance
Ferring Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- FE 999302 and placebo were identical in appearance and the trial was considered double-blind as neither the subject nor the investigator knew whether the subject was receiving FE 999302 or placebo.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2018
First Posted
June 21, 2018
Study Start
May 14, 2018
Primary Completion
October 21, 2019
Study Completion
January 8, 2020
Last Updated
August 31, 2023
Record last verified: 2020-01