Controlled Ovarian StimulationPhase 2RAINBOWNCT03564509
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.
A Phase 2 study testing FE 999302 (1 μg) and follitropin delta, FE 999302 (2 μg) and follitropin delta and FE 999302 (4 μg) and follitropin delta in people with Controlled Ovarian Stimulation, run by Ferring Pharmaceuticals at 20 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 30 to 42 years, women only
- Conditions the study is for
- Controlled Ovarian Stimulation
- What is being tested?
- FE 999302 (1 μg) and follitropin delta, FE 999302 (2 μg) and follitropin delta and FE 999302 (4 μg) and follitropin delta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 620 participants
- Where
- 20 sitesin 5 countries
- Study dates
- 14 May 2018to 8 Jan 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
20 sites in 5 countries.
20 sites in 5 countries
Spain6 sites
Dexeus Woman's Health
Barcelona
Instituto Valenciano de Infertilidad (IVI) - Bilbao
Leioa
GINEFIV - Clinica Belen Location
Madrid
Instituto Valenciano de Infertilidad (IVI) - Madrid
Madrid
Instituto Valenciano de Infertilidad (IVI) - Sevilla
Seville
Instituto Valenciano de Infertilidad (IVI) - Valencia
Valencia
Czechia4 sites
Institut fur Reproduktionsmedizin und Genetik
Karlovy Vary
Fertimed
Olomouc
GYNEM
Prague
IVF CUBE
Prague
Denmark4 sites
Aalborg University Hospital
Aalborg
Rigshospitalet
Copenhagen
Dansk Fertilitetsklinik
Frederiksberg
Hvidovre Hospital
Hvidovre
United Kingdom4 sites
Glasgow Royal Infirmary
Glasgow
Liverpool Women's Hospital
Liverpool
Guy's and St Thomas' NHS Trust
London
Kings College (Assisted Conception Unit)
London
Belgium2 sites
Universitair Ziekenhuis Gent (UZ Gent)
Ghent
Universitair Ziekenhuis Brussel
Jette
About this study
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
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.
- Conditions
- Controlled Ovarian Stimulation
- Being tested
- FE 999302 (1 μg) and follitropin delta, FE 999302 (2 μg) and follitropin delta, FE 999302 (4 μg) and follitropin delta, FE 999302 (8 μg) and follitropin delta, FE 999302 (12 μg) and follitropin delta
- Keywords
- Human Chorionic Gonadotropin (hCG), Recombinant Human Chorionic Gonadotropin (rhCG), Controlled Ovarian Stimulation (COS), Assisted Reproductive Technologies (ART)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FE 999302 (1 μg) and follitropin deltaDrug
Also called Choriogonadotropin beta
Daily dose of 1 μg of FE 999302, a recombinant human chorionic gonadotropin (rhCG) solution for subcutaneous injection; individualized follitropin delta dose.
FE 999302 (2 μg) and follitropin deltaDrug
Also called Choriogonadotropin beta
Daily dose of 2 μg of FE 999302, a rhCG solution for subcutaneous injection; individualized follitropin delta dose.
FE 999302 (4 μg) and follitropin deltaDrug
Also called Choriogonadotropin beta
Daily dose of 4 μg of FE 999302, a rhCG solution for subcutaneous injection; individualized follitropin delta dose.
FE 999302 (8 μg) and follitropin deltaDrug
Also called Choriogonadotropin beta
Daily dose of 8 μg of FE 999302, a rhCG solution for subcutaneous injection; individualized follitropin delta dose.
FE 999302 (12 μg) and follitropin deltaDrug
Also called Choriogonadotropin beta
Daily dose of 12 μg of FE 999302, a rhCG solution for subcutaneous injection; individualized follitropin delta dose.
Placebo and follitropin deltaOther
Daily dose of placebo; individualized follitropin delta dose.
| Study group | Role | What they receive |
|---|---|---|
| FE 999302 (1 μg) and follitropin delta | Experimental | Not described Receives: Drug: FE 999302 (1 μg) and follitropin delta |
| FE 999302 (2 μg) and follitropin delta | Experimental | Not described Receives: Drug: FE 999302 (2 μg) and follitropin delta |
| FE 999302 (4 μg) and follitropin delta | Experimental | Not described Receives: Drug: FE 999302 (4 μg) and follitropin delta |
| FE 999302 (8 μg) and follitropin delta | Experimental | Not described Receives: Drug: FE 999302 (8 μg) and follitropin delta |
| FE 999302 (12 μg) and follitropin delta | Experimental | Not described Receives: Drug: FE 999302 (12 μg) and follitropin delta |
| Placebo and follitropin delta | Placebo comparator | Not described Receives: Other: Placebo and follitropin delta |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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).
Measured: On Day 5 after oocyte retrieval
Number of subjects with at least two 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).
Measured: On Day 5 after oocyte retrieval
Number and quality of embryos on Day 3 after oocyte retrieval
Embryo quality was assessed by cleavage stage and embryo morphology parameters. The total number of embryos and the number of embryos per quality category were reported.
Measured: On Day 3 after oocyte retrieval
Number and quality of blastocysts on Day 5 after oocyte retrieval
Blastocyst quality 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 cells).
The total number of blastocysts and the number of blastocysts per quality category will be reported.
Measured: On Day 5 after oocyte retrieval
Changes in serum hormone levels
Blood samples for analysis of hormone concentrations were drawn at stimulation Day 1, stimulation Day 6, stimulation Day 8, last day of stimulation, and at oocyte retrieval.
Measured: Stimulation Day 1 (baseline), stimulation Day 6, stimulation Day 8, end-of-stimulation (up to 20 stimulation days), and oocyte retrieval
Number and size of follicles on stimulation Day 6
Number and size of follicles assessed using transvaginal ultrasound. The total number of follicles and the number of follicles per size category were reported.
Measured: On stimulation Day 6
Number and size of follicles at end-of-stimulation
Number and size of follicles assessed using transvaginal ultrasound. The total number of follicles and the number of follicles per size category were reported.
Measured: At end-of-stimulation (up to 20 stimulation days)
Positive beta human chorionic gonadotropin (βhCG) rate
Proportion of patients with positive blood βhCG confirmed by a blood test.
Measured: 13-15 days after blastocyst transfer
Clinical pregnancy rate
Clinical pregnancy was defined as at least one gestational sac, either intrauterine or ectopic.
Measured: 5-6 weeks after blastocyst transfer
Vital pregnancy rate
Vital pregnancy was defined as at least one intrauterine gestational sac with fetal heart beat, as assessed by transvaginal ultrasound.
Measured: 5-6 weeks after blastocyst transfer
Ongoing pregnancy rate
Ongoing pregnancy was defined as at least one intrauterine viable fetus, assessed using transvaginal or abdominal ultrasound.
Measured: 10-11 weeks after blastocyst transfer
Number of oocytes retrieved
Measured: On the day of oocyte retrieval
Number of metaphase II oocytes
Measured: On the day of oocyte retrieval
Number of fertilised 2 pronuclei (2PN) oocytes
Measured: On day 1 after insemination
Total gonadotropin dose
The daily dose of FE 999302 or placebo, and follitropin delta were recorded.
Measured: At end-of-stimulation (up to 20 stimulation days)
Total number of stimulation days
The start and end dates of administration of FE 999302 or placebo, and follitropin delta were recorded.
Measured: At end-of-stimulation (up to 20 stimulation days)
Incidence of cycle cancellation
Cycle cancellation due to poor ovarian response or excessive ovarian response.
Measured: At end-of-stimulation (up to 20 stimulation days)
Serum concentrations of FE 999302
Measured: On stimulation Day 1 (prior to first dose of FE 999302 or placebo), stimulation Day 6, stimulation Day 8, end-of-stimulation (up to 20 stimulation days)
Incidence of ovarian hyperstimulation syndrome (OHSS) (early or late, any grade)
Early OHSS was defined as OHSS with onset less than equal to 9 days after triggering of final follicular maturation.
Late OHSS was defined as OHSS with onset greater than 9 days after triggering of final follicular maturation.
All OHSS cases were graded as mild, moderate or severe.
Measured: From stimulation Day 1 to end-of-trial (estimated maximum of 4 months from start of stimulation)
Incidence and intensity of adverse events (AEs)
Measured: From screening to end-of-trial (estimated maximum of 4 months from start of stimulation)
Changes in circulating levels of clinical chemistry and haematology parameters
Measured: At screening, on stimulation Day 1, end-of-stimulation (up to 20 stimulation days), end-of-trial (estimated maximum of 4 months from start of stimulation)
Incidence and intensity of injection site reactions after FE 999302 administration (redness, pain, itching, swelling and bruising) assessed by the subject during the stimulation period
Measured: Immediately after injection of FE 999302 or placebo, 30 minutes after injection, and 24 hours after injection
Incidence of treatment-induced anti-FE 999302 antibodies, overall as well as with neutralising capacity
The proportion of subjects with treatment-induced anti-FE999302 antibodies as well as the proportion of subjects with treatment-induced anti-FE999302 antibodies with neutralizing capacity were reported.
Measured: On stimulation Day 1, end-of-stimulation (up to 20 stimulation days), 19-28 days after the last FE999302 or placebo dose
Incidence of multi-fetal gestation
Measured: 5 to 6 weeks after transfer
Incidence of biochemical pregnancy
Biochemical pregnancy was defined as positive βhCG test but no gestational sac was observed on transvaginal ultrasound conducted later, or menstruation is
was reported.
Measured: Up to 5 to 6 weeks after transfer
Incidence of spontaneous abortion (with and without medical/surgical intervention)
Spontaneous abortion was defined as positive βhCG test but all intrauterine gestational sacs without fetal heart beat as documented by ultrasound, or there were no viable fetuses observed by ultrasound.
Measured: Up to 10 to 11 weeks after transfer
Incidence of ectopic pregnancy (with and without medical/surgical intervention)
Ectopic pregnancy was defined as extrauterine gestational sac with or without fetal heart beat as documented by ultrasound or surgery.
Measured: Up to 5 to 6 weeks after transfer
Incidence of vanishing twins
Vanishing twin was defined as spontaneous disappearance of an intrauterine gestational sac with or without heart beat in a pregnancy where one viable fetus remained as documented by ultrasound.
Measured: Up to 10 to 11 weeks after transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start14 May 2018
- Primary completion21 Oct 2019
- Study completion8 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Controlled Ovarian StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 620 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Compliance, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564509
- Sponsor's protocol ID
- 000289
- Other IDs
- 2017-003810-13, 2017
- Acronym
- RAINBOW
- Status last verified
- Jan 2020
- First submitted
- 16 May 2018
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37194068
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03564509
- Acronym / sponsor ID
- RAINBOW / 000289
- Conditions
- Controlled Ovarian Stimulation
- Keywords
- Human Chorionic Gonadotropin (hCG), Recombinant Human Chorionic Gonadotropin (rhCG), Controlled Ovarian Stimulation (COS), Assisted Reproductive Technologies (ART)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 620 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 14 May 2018 (actual)
- Primary completion
- 21 Oct 2019 (actual)
- Study completion
- 8 Jan 2020 (actual)
- First posted
- 21 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| FE 999302 (1 μg) and follitropin delta | Experimental | Drug: FE 999302 (1 μg) and follitropin delta |
| FE 999302 (2 μg) and follitropin delta | Experimental | Drug: FE 999302 (2 μg) and follitropin delta |
| FE 999302 (4 μg) and follitropin delta | Experimental | Drug: FE 999302 (4 μg) and follitropin delta |
| FE 999302 (8 μg) and follitropin delta | Experimental | Drug: FE 999302 (8 μg) and follitropin delta |
| FE 999302 (12 μg) and follitropin delta | Experimental | Drug: FE 999302 (12 μg) and follitropin delta |
| Placebo and follitropin delta | Placebo comparator | Other: Placebo and follitropin delta |
Who may qualify
- Ages
- 30 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FE 999302 (1 μg) and follitropin deltaAlso: Choriogonadotropin betaDaily dose of 1 μg of FE 999302, a recombinant human chorionic gonadotropin (rhCG) solution for subcutaneous injection; individualized follitropin delta dose. | Drug | FE 999302 (1 μg) and follitropin delta |
| FE 999302 (2 μg) and follitropin deltaAlso: Choriogonadotropin betaDaily dose of 2 μg of FE 999302, a rhCG solution for subcutaneous injection; individualized follitropin delta dose. | Drug | FE 999302 (2 μg) and follitropin delta |
| FE 999302 (4 μg) and follitropin deltaAlso: Choriogonadotropin betaDaily dose of 4 μg of FE 999302, a rhCG solution for subcutaneous injection; individualized follitropin delta dose. | Drug | FE 999302 (4 μg) and follitropin delta |
| FE 999302 (8 μg) and follitropin deltaAlso: Choriogonadotropin betaDaily dose of 8 μg of FE 999302, a rhCG solution for subcutaneous injection; individualized follitropin delta dose. | Drug | FE 999302 (8 μg) and follitropin delta |
| FE 999302 (12 μg) and follitropin deltaAlso: Choriogonadotropin betaDaily dose of 12 μg of FE 999302, a rhCG solution for subcutaneous injection; individualized follitropin delta dose. | Drug | FE 999302 (12 μg) and follitropin delta |
| Placebo and follitropin deltaDaily dose of placebo; individualized follitropin delta dose. | Other | Placebo and follitropin delta |
Primary outcome
Number of good-quality blastocysts on Day 5 after oocyte retrieval
Time frame: 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).
28 secondary outcomes
Number of subjects with at least one good-quality blastocyst on Day 5 after oocyte retrieval
Time frame: On Day 5 after oocyte retrieval
Number of subjects with at least two good-quality blastocysts on Day 5 after oocyte retrieval
Time frame: On Day 5 after oocyte retrieval
Number and quality of embryos on Day 3 after oocyte retrieval
Time frame: On Day 3 after oocyte retrieval
Number and quality of blastocysts on Day 5 after oocyte retrieval
Time frame: On Day 5 after oocyte retrieval
Changes in serum hormone levels
Time frame: Stimulation Day 1 (baseline), stimulation Day 6, stimulation Day 8, end-of-stimulation (up to 20 stimulation days), and oocyte retrieval
Number and size of follicles on stimulation Day 6
Time frame: On stimulation Day 6
Number and size of follicles at end-of-stimulation
Time frame: At end-of-stimulation (up to 20 stimulation days)
Positive beta human chorionic gonadotropin (βhCG) rate
Time frame: 13-15 days after blastocyst transfer
Clinical pregnancy rate
Time frame: 5-6 weeks after blastocyst transfer
Vital pregnancy rate
Time frame: 5-6 weeks after blastocyst transfer
Ongoing pregnancy rate
Time frame: 10-11 weeks after blastocyst transfer
Number of oocytes retrieved
Time frame: On the day of oocyte retrieval
Number of metaphase II oocytes
Time frame: On the day of oocyte retrieval
Number of fertilised 2 pronuclei (2PN) oocytes
Time frame: On day 1 after insemination
Total gonadotropin dose
Time frame: At end-of-stimulation (up to 20 stimulation days)
Total number of stimulation days
Time frame: At end-of-stimulation (up to 20 stimulation days)
Incidence of cycle cancellation
Time frame: At end-of-stimulation (up to 20 stimulation days)
Serum concentrations of FE 999302
Time frame: On stimulation Day 1 (prior to first dose of FE 999302 or placebo), stimulation Day 6, stimulation Day 8, end-of-stimulation (up to 20 stimulation days)
Incidence of ovarian hyperstimulation syndrome (OHSS) (early or late, any grade)
Time frame: From stimulation Day 1 to end-of-trial (estimated maximum of 4 months from start of stimulation)
Incidence and intensity of adverse events (AEs)
Time frame: From screening to end-of-trial (estimated maximum of 4 months from start of stimulation)
Changes in circulating levels of clinical chemistry and haematology parameters
Time frame: At screening, on stimulation Day 1, end-of-stimulation (up to 20 stimulation days), end-of-trial (estimated maximum of 4 months from start of stimulation)
Incidence and intensity of injection site reactions after FE 999302 administration (redness, pain, itching, swelling and bruising) assessed by the subject during the stimulation period
Time frame: Immediately after injection of FE 999302 or placebo, 30 minutes after injection, and 24 hours after injection
Incidence of treatment-induced anti-FE 999302 antibodies, overall as well as with neutralising capacity
Time frame: On stimulation Day 1, end-of-stimulation (up to 20 stimulation days), 19-28 days after the last FE999302 or placebo dose
Incidence of multi-fetal gestation
Time frame: 5 to 6 weeks after transfer
Incidence of biochemical pregnancy
Time frame: Up to 5 to 6 weeks after transfer
Incidence of spontaneous abortion (with and without medical/surgical intervention)
Time frame: Up to 10 to 11 weeks after transfer
Incidence of ectopic pregnancy (with and without medical/surgical intervention)
Time frame: Up to 5 to 6 weeks after transfer
Incidence of vanishing twins
Time frame: Up to 10 to 11 weeks after transfer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Results publication: PubMed 37194068Sanchez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Compliance study director
Ferring Pharmaceuticals
20 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FE 999302 (1 μg) and follitropin delta, FE 999302 (2 μg) and follitropin delta and FE 999302 (4 μg) and follitropin delta in people with Controlled Ovarian Stimulation, run by Ferring Pharmaceuticals at 20 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain, Czechia, Denmark, United Kingdom, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of good-quality blastocysts on Day 5 after oocyte retrieval (time frame: On Day 5 after oocyte retrieval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03564509, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2023.