FertilityPhase 1Celestial-1NCT06466486
An Exploratory Study to Investigate the Effect of FE 999302 When Given Together With Follitropin Delta During Controlled Ovarian Stimulation
A Phase 1 study testing Follitropin delta and FE999302 in people with Fertility, run by Ferring Pharmaceuticals at 15 sites in 5 countries.
Trial summary
This is a phase 1b clinical trial with Choriogonadotropin beta (FE999302) and Follitropin delta (Rekovelle). The trial is multicentre, randomized, partially double-blind, placebo-controlled, parallel-group investigating the effect of FE999302 on parameters influencing pregnancy rates in women undergoing controlled… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility
- What is being tested?
- Follitropin delta and FE999302
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 310 participants
- Where
- 15 sitesin 5 countries
- Study dates
- 14 Jun 2024to 3 Dec 2025
- Phase
- Phase 1
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject informed consent form signed before any trial-related activities.
- In good physical and mental health as judged by the investigator.
- Serum anti-Müllerian hormone (AMH) levels of 15.0-35.0 pmol/L at screening (measured at central laboratory).
- Pre-menopausal women between the ages of 18 and 40 years. The subjects must be at least 18 years (including the 18th birthday) and no more than 40 years (up to the day before the 41st birthday) when they sign the informed consent(s).
- 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 (IVF) and/or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm donor.
- Infertility for at least 1 year before screening for subjects <35 years or for at least 6 months for subjects ≥35 years (not applicable in case of tubal or severe male factor infertility).
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- No more than two controlled ovarian stimulation cycles initiated, regardless of outcome (taking exclusion criteria 2 and 3 into account) and the subject must be suitable for treatment with 10 or 15 µg/day follitropin delta (corresponding to 150 or 225 IU).
- Regular menstrual cycles of 24-35 days (both inclusive), presumed to be ovulatory.
- Early follicular phase (cycle day 2-5) serum levels of follicle-stimulating hormone (FSH) between 1 and 15 IU/L (measured at central laboratory).
- Body mass index (BMI) between 18.0 and 30.0 kg/m2 (both inclusive) at screening.
Who cannot join
- Known polycystic ovary syndrome (PCOS) or known endometriosis stage III-IV (American Society for Reproductive Medicine, 2012).
- Poor response in a previous controlled ovarian stimulation cycle using a gonadotropin starting dose of 150 IU/day or higher. Poor response is defined as <4 oocytes retrieved, or cycle cancellation before oocyte retrieval due to inadequate follicular development.
- Excessive ovarian response in a previous controlled ovarian stimulation cycle for IVF/ICSI using a daily FSH/ human menopausal gonadotropin (hMG) dose of ≤225 IU, defined as ≥25 oocytes retrieved or cycle cancellation before oocyte retrieval due to excessive ovarian response, including risk of ovarian hyperstimulation syndrome (OHSS).
- One or more follicles ≥10 mm (including cysts) observed on the transvaginal ultrasound before randomisation on stimulation day 1 (puncture of cysts is allowed before randomisation).
- Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy [excluding ectopic pregnancy] and before week 24 of pregnancy).
- Any known clinically significant systemic disease (e.g. insulin-dependent diabetes).
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- Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver, or kidney) with the exception of controlled thyroid function disease.
- Known tumours of the ovary, breast, uterus, adrenal gland, pituitary, or hypothalamus which would contraindicate the use of gonadotropins.
- Any abnormal finding of clinical chemistry and haematology at screening or vital signs at randomisation, which is judged clinically relevant by the investigator and/or requires intervention.
- Currently breast-feeding.
- Undiagnosed vaginal bleeding.
- Findings at the gynaecological examination at screening which preclude gonadotropin stimulation or are associated with a reduced chance of pregnancy, e.g. congenital uterine abnormalities or retained intrauterine device.
- Pregnancy (negative urinary pregnancy tests must be documented at screening and before randomisation) or contraindication to pregnancy.
- Use of fertility modifiers during the last menstrual cycle before start of stimulation in the trial, including dehydroepiandrosterone (DHEA) and metformin or cycle programming with oral contraceptives, progestogen, or estrogen preparations
Trial locations and contacts
15 sites in 5 countries.
15 sites in 5 countries
Spain5 sites
Ferring Investigational Site
Barcelona, 08028
Ferring Investigational Site
Madrid, Aravaca, 28023
Ferring Investigational Site
Madrid, 28010
Ferring Investigational Site
Seville, 41092
Ferring Investigational Site
Valencia, 46015
Czechia3 sites
Ferring Investigational Site
Prague, Prague, 150 00
Ferring Investigational Site
Prague, 160 00
Ferring Investigational Site
Prague, 184 00
Norway3 sites
Ferring Investigational Site
Bergen, 5006
Ferring Investigational Site
Porsgrunn, 3913
Ferring Investigational Site
Trondheim, Sor-Trondelag, 7042
Belgium2 sites
Ferring Investigational Site
Brussels, 1090
Ferring Investigational Site
Edegem, 2650
Denmark2 sites
Ferring Investigational Site
Copenhagen, 2100
Ferring Investigational Site
Hvidovre, Hvidovre, 2650
About this study
Official title: A Randomised, Partially Double-blind, Placebo-controlled, Parallel-group Exploratory Trial to Investigate the Effect of FE999302 in Women Undergoing Controlled Ovarian Stimulation With a Fixed Dose of Follitropin Delta in a Gonadotropin-releasing Hormone Antagonist Protocol
This is a phase 1b clinical trial with Choriogonadotropin beta (FE999302) and Follitropin delta (Rekovelle).
The trial is multicentre, randomized, partially double-blind, placebo-controlled, parallel-group investigating the effect of FE999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin.
Read more
The primary endpoint is the number of good-quality blastocysts on day 5 after oocyte retrieval.
Secondary endpoints are number of follicles by size category and serum concentration of different hormones on stimulation day 6 and end-of stimulation, the number of stimulation days and oocytes retrieved, the number of metaphase II oocytes and fertilised oocytes, number of blastocysts on day 5, number of cryopreserved blastocysts, endometrial thickness at eos, positive bhcg rate, clinical pregnancy, vital pregnancy and ongoing pregnancy.
- Conditions
- Fertility
- Being tested
- Follitropin delta, FE999302, FE999302 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follitropin deltaDrug
Also called REKOVELLE
The effect on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin.
FE999302Drug
To investigate the effect of FE 999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a gonadotropin-releasing hormone (GnRH) antagonist protocol
FE999302 PlaceboDrug
To investigate the effect of FE 999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a gonadotropin-releasing hormone (GnRH) antagonist protocol
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Follitropin delta and FE 999302 placebo Receives: Drug: Follitropin delta; Drug: FE999302 Placebo |
| FE999302 and Placebo Every 2nd Day Group | Active comparator | Follitropin delta and FE 999302 every 2nd day and FE 999302 placebo every 2nd day Receives: Drug: Follitropin delta; Drug: FE999302; Drug: FE999302 Placebo |
| FE999302 Dose Group 1 | Active comparator | Follitropin delta and FE 999302 Receives: Drug: Follitropin delta; Drug: FE999302 |
| FE999302 Dose Group 2 | Active comparator | Follitropin delta and FE 999302 Receives: Drug: Follitropin delta; Drug: FE999302 |
| Placebo Group 2 | Placebo comparator | Follitropin delta and FE 999302 placebo Receives: Drug: Follitropin delta; Drug: FE999302 Placebo |
| FE999302 Dose Group 3 | Active comparator | Follitropin delta and FE 999302 Receives: Drug: Follitropin delta; Drug: FE999302 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of good-quality blastocysts
The number of good-quality blastocysts
Measured: Day 5 after oocyte retrieval.
Secondary outcomes (14)
Number and size of follicles
Number of follicles by size category
Measured: On stimulation day 6 and up to 20 days
Serum hormone concentrations
Serum hormone concentrations of progesterone, 17-OH-progesterone, androstenedione, testosterone, estradiol, inhibin B, and luteinising hormone (LH) on stimulation day 6 and at end of stimulation.
Measured: On stimulation day 6, and up to 20 days
Serum hormone concentrations
Serum hormone concentrations of progesterone, 17-OH-progesterone, androstenedione, testosterone, and estradiol at oocyte retrieval
Measured: Up to 22 days
Number of Stimulation days
Number of stimulation days
Measured: Up to 20 days
Number of oocytes
Number of oocytes retrieved
Measured: Up to 22 days
Number of metaphase II oocytes
Number of metaphase II (MII) oocytes
Measured: Up to 22 days
Number of fertilised oocytes
Number of fertilised (2 pronuclei [2PN]) oocytes
Measured: Up to 22 days
Number of blastocysts
Number of blastocysts
Measured: Up to 27 days
Number of cryopreserved blastocysts
Number of cryopreserved blastocysts
Measured: Up to 28 days
Endometrial thickness
Endometrial thickness
Measured: Up to 20 days, and up to 27 days
Positive βhCG
Positive βhCG (positive serum βhCG test )
Measured: 13 to 15 days after fresh transfer
Clinical pregnancy
Clinical pregnancy (at least one gestational sac)
Measured: 5-6 weeks after fresh transfer
Vital pregnancy
Vital pregnancy (at least one intrauterine gestational sac with fetal heart beat)
Measured: 5-6 weeks after fresh transfer
Ongoing pregnancy
Ongoing pregnancy (at least one intrauterine viable fetus)
Measured: 10-11 weeks after fresh transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start14 Jun 2024
- Primary completion3 Dec 2025
- Study completion3 Dec 2025
Why it stopped: This is a company decision made not related to safety concerns. Rather, it reflects a broader portfolio assessment and the desire to focus on programs that can bring timely and meaningful benefit to patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FertilityStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 310 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
- NCT06466486
- Sponsor's protocol ID
- 000426
- Other IDs
- 2023-507630-25-00, 2023
- Acronym
- Celestial-1
- Status last verified
- Mar 2026
- First submitted
- 29 May 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Partially Double-blind, Placebo-controlled, Parallel-group Exploratory Trial to Investigate the Effect of FE999302 in Women Undergoing Controlled Ovarian Stimulation With a Fixed Dose of Follitropin Delta in a Gonadotropin-releasing Hormone Antagonist Protocol
- ClinicalTrials.gov ID
- NCT06466486
- Acronym / sponsor ID
- Celestial-1 / 000426
- Conditions
- Fertility
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This is a company decision made not related to safety concerns. Rather, it reflects a broader portfolio assessment and the desire to focus on programs that can bring timely and meaningful benefit to patients.
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 3 Dec 2025 (actual)
- Study completion
- 3 Dec 2025 (actual)
- First posted
- 20 Jun 2024 (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.
This is a phase 1b clinical trial with Choriogonadotropin beta (FE999302) and Follitropin delta (Rekovelle).
The trial is multicentre, randomized, partially double-blind, placebo-controlled, parallel-group investigating the effect of FE999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin.
The primary endpoint is the number of good-quality blastocysts on day 5 after oocyte retrieval.
Secondary endpoints are number of follicles by size category and serum concentration of different hormones on stimulation day 6 and end-of stimulation, the number of stimulation days and oocytes retrieved, the number of metaphase II oocytes and fertilised oocytes, number of blastocysts on day 5, number of cryopreserved blastocysts, endometrial thickness at eos, positive bhcg rate, clinical pregnancy, vital pregnancy and ongoing pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Follitropin delta, Drug: FE999302 PlaceboFollitropin delta and FE 999302 placebo |
| FE999302 and Placebo Every 2nd Day Group | Active comparator | Drug: Follitropin delta, Drug: FE999302, Drug: FE999302 PlaceboFollitropin delta and FE 999302 every 2nd day and FE 999302 placebo every 2nd day |
| FE999302 Dose Group 1 | Active comparator | Drug: Follitropin delta, Drug: FE999302Follitropin delta and FE 999302 |
| FE999302 Dose Group 2 | Active comparator | Drug: Follitropin delta, Drug: FE999302Follitropin delta and FE 999302 |
| Placebo Group 2 | Placebo comparator | Drug: Follitropin delta, Drug: FE999302 PlaceboFollitropin delta and FE 999302 placebo |
| FE999302 Dose Group 3 | Active comparator | Drug: Follitropin delta, Drug: FE999302Follitropin delta and FE 999302 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Subject informed consent form signed before any trial-related activities.
- In good physical and mental health as judged by the investigator.
- Serum anti-Müllerian hormone (AMH) levels of 15.0-35.0 pmol/L at screening (measured at central laboratory).
- Pre-menopausal women between the ages of 18 and 40 years. The subjects must be at least 18 years (including the 18th birthday) and no more than 40 years (up to the day before the 41st birthday) when they sign the informed consent(s).
- 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 (IVF) and/or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm donor.
Key exclusion criteria (14 listed)
- Known polycystic ovary syndrome (PCOS) or known endometriosis stage III-IV (American Society for Reproductive Medicine, 2012).
- Poor response in a previous controlled ovarian stimulation cycle using a gonadotropin starting dose of 150 IU/day or higher. Poor response is defined as <4 oocytes retrieved, or cycle cancellation before oocyte retrieval due to inadequate follicular development.
- Excessive ovarian response in a previous controlled ovarian stimulation cycle for IVF/ICSI using a daily FSH/ human menopausal gonadotropin (hMG) dose of ≤225 IU, defined as ≥25 oocytes retrieved or cycle cancellation before oocyte retrieval due to excessive ovarian response, including risk of ovarian hyperstimulation syndrome (OHSS).
- One or more follicles ≥10 mm (including cysts) observed on the transvaginal ultrasound before randomisation on stimulation day 1 (puncture of cysts is allowed before randomisation).
- Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy [excluding ectopic pregnancy] and before week 24 of 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 |
|---|---|---|
| Follitropin deltaAlso: REKOVELLEThe effect on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin. | Drug | FE999302 Dose Group 1, FE999302 Dose Group 2, FE999302 Dose Group 3, FE999302 and Placebo Every 2nd Day Group, Placebo, Placebo Group 2 |
| FE999302To investigate the effect of FE 999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a gonadotropin-releasing hormone (GnRH) antagonist protocol | Drug | FE999302 Dose Group 1, FE999302 Dose Group 2, FE999302 Dose Group 3, FE999302 and Placebo Every 2nd Day Group |
| FE999302 PlaceboTo investigate the effect of FE 999302 on parameters influencing pregnancy rates in women undergoing controlled ovarian stimulation with a fixed dose of follitropin delta in a gonadotropin-releasing hormone (GnRH) antagonist protocol | Drug | FE999302 and Placebo Every 2nd Day Group, Placebo, Placebo Group 2 |
Primary outcome
Number of good-quality blastocysts
Time frame: Day 5 after oocyte retrieval.
The number of good-quality blastocysts
14 secondary outcomes
Number and size of follicles
Time frame: On stimulation day 6 and up to 20 days
Serum hormone concentrations
Time frame: On stimulation day 6, and up to 20 days
Serum hormone concentrations
Time frame: Up to 22 days
Number of Stimulation days
Time frame: Up to 20 days
Number of oocytes
Time frame: Up to 22 days
Number of metaphase II oocytes
Time frame: Up to 22 days
Number of fertilised oocytes
Time frame: Up to 22 days
Number of blastocysts
Time frame: Up to 27 days
Number of cryopreserved blastocysts
Time frame: Up to 28 days
Endometrial thickness
Time frame: Up to 20 days, and up to 27 days
Positive βhCG
Time frame: 13 to 15 days after fresh transfer
Clinical pregnancy
Time frame: 5-6 weeks after fresh transfer
Vital pregnancy
Time frame: 5-6 weeks after fresh transfer
Ongoing pregnancy
Time frame: 10-11 weeks after fresh transfer
Results and safety
The study was stopped early (reason given: This is a company decision made not related to safety concerns. Rather, it reflects a broader portfolio assessment and the desire to focus on programs that can bring timely and meaningful benefit to patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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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
15 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Follitropin delta and FE999302 in people with Fertility, run by Ferring Pharmaceuticals at 15 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 10 inclusion and 14 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: stopped early, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Spain, Czechia, Norway, Belgium, Denmark. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: This is a company decision made not related to safety concerns. Rather, it reflects a broader portfolio assessment and the desire to focus on programs that can bring timely and meaningful benefit to patients.). Results are not available in the source record.
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 (time frame: 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?
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 30 Mar 2026.