Infertility, FemalePhase 3COCONCT06173869
A Randomised Trial Comparing the Ovarian Response of a Starting Dose of Either 10 μg or 15 μg Follitropin Delta (FE 999049) to a Starting Dose of Either 150 IU or 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in China
A Phase 3 study testing FE 999049 and GONAL-F in people with Infertility, Female, run by Ferring Pharmaceuticals at 11 sites in China.
Trial summary
This is a phase 3b clinical trial with follitropin delta (FE 999049) and Gonal-F. The trial is a randomised, controlled, assessor-blind, parallel groups, multicentre trial comparing the ovarian response of a starting dose of either 10mg or 15 mg follitropin delta to a starting dose of either 150 IU or 225 IU Gonal-F… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- FE 999049 and GONAL-F
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 11 sitesChina
- Study dates
- 29 Mar 2024to 31 May 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Signed and dated Informed Consent Form for participation in the trial, obtained before any trial-related procedures.
- In good physical and mental health in the judgement of the investigator.
- Chinese pre-menopausal female between the ages of 20 and 40 years; at least 20 years (including the 20th birthday) when signing the informed consent and no more than 40 years (up to the day before the 41st birthday) at the time of randomisation.
- Eligible for ovarian stimulation with a dose equivalent to 150 IU GONAL-F or 225 IU GONAL-F, as judged by the investigator.
- Body mass index (BMI) between 17.5 and 32.0 kg/m2 (both inclusive) at screening.
- 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) or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm donor
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- Infertility for at least one year before randomisation for subjects <35 years or for at least 6 months for subjects ≥35 years (criteria not applicable in case of tubal or severe male factor infertility).
- Regular menstrual cycles of 24-35 days (both inclusive), presumed to be ovulatory.
- Transvaginal ultrasound documenting presence and adequate visualisation of both ovaries, without evidence of significant abnormality. Both ovaries must be accessible for oocyte retrieval.
- Early follicular phase (cycle day 2-4) serum levels of follicle-stimulating hormone (FSH) between 1 and 15 IU/L (results obtained within 3 months prior to randomisation).
- Serum anti-Müllerian hormone (AMH) concentration of ≤35 pmol/L at screening.
Who cannot join
- Primary ovarian failure.
- More than three previous controlled ovarian stimulation cycles initiated, regardless of outcome.
- History of previous episode of OHSS, exuberant ovarian response to gonadotropins, or polycystic ovarian syndrome.
- Known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the trial 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.
- Fibroid tumours of the uterus incompatible with pregnancy.
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- Currently breast-feeding.
- Known inherited or acquired thrombophilia disease.
- Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.
- Known porphyria.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
Ferring Investigational Site
Chengdu, Sichuang, 610041
Ferring Investigational Site
Guangzhou, Guandong, 510120
Ferring Investigational Site
Guangzhou, Guangdong, 510000
Ferring Investigational Site
Nanchang, Jiangxi, 330038
Ferring Investigational Site
Shanghai, Shanghai Municipality, 201204
Ferring Investigational Site
Shengyang, Liaoling, 110004
Ferring Investigational Site
Shushan, Anhui, 230032
Ferring Investigational Site
Tianjin, Tianjin Municipality, 300052
Ferring Investigational Site
Xiaobailou, Tianjin Municipality, 300052
Ferring Investigational Site
Yuzhong, Chongqing Municipality, 401147
Ferring Investigational Site
Zhengzhou, Henan
About this study
Official title: A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial Comparing the Ovarian Response of a Starting Dose of Either 10 μg or 15 μg Follitropin Delta (FE 999049) to a Starting Dose of Either 150 IU or 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme in China
This is a phase 3b clinical trial with follitropin delta (FE 999049) and Gonal-F. The trial is a randomised, controlled, assessor-blind, parallel groups, multicentre trial comparing the ovarian response of a starting dose of either 10mg or 15 mg follitropin delta to a starting dose of either 150 IU or 225 IU Gonal-F in a long GnRH agonist protocol in women undergoing an assisted reproductive technology programme in China.
- Conditions
- Infertility, Female
- Being tested
- FE 999049, GONAL-F
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FE 999049Drug
Also called Rekovelle, Follitropin Delta
FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose could be increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants could be treated for a maximum of 20 days.
GONAL-FDrug
GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose could be increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants could be treated for a maximum of 20 days.
Coasting was not allowed.
| Study group | Role | What they receive |
|---|---|---|
| FE 999049 | Experimental | The participants receive either low or high starting dose as appropriate according to Investigators Judgement.
10 or 15 µg Receives: Drug: FE 999049 |
| GONAL-F | Active comparator | The participants receive either low or high starting dose as appropriate according to Investigators Judgement.
150 or 225 IU. Receives: Drug: GONAL-F |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Oocytes Retrieved
Measured: On day of oocyte retrieval (up to 22 days after start of stimulation)
Secondary outcomes (15)
Number of Follicles on Stimulation Day 6 and End-of-stimulation
Measured: Stimulation day 6 and end-of-stimulation (maximum stimulation day 20)
Serum Concentrations of Estradiol on Stimulation Day 6 and End-of-stimulation
Measured: stimulation day 6 and end-of-stimulation (maximum stimulation day 20)
Serum Concentrations of Progesterone on Stimulation Day 6 and End-of-stimulation
Measured: stimulation day 6 and end-of-stimulation (maximum stimulation day 20)
Number of Fertilised Oocytes
Measured: On day 1 after oocyte retrieval (up to 23 days after start of stimulation)
Fertilisation Rate
Measured: On day 1 after oocyte retrieval (up to 23 days after start of stimulation)
Number of Embryos (Total and Quality)
Measured: Day 3 after oocyte retrieval
Total Gonadotropin Dose
Measured: Up to 20 stimulation days
Number of Stimulation Days
Measured: Up to 20 stimulation days
Positive βhCG (Positive Serum βhCG Test 13-15 Days After Transfer) Rate
Measured: 13-15 days after transfer
Clinical Pregnancy (at Least One Gestational Sac 5-6 Weeks After Transfer) Rate
Measured: 5-6 weeks after transfer
Vital Pregnancy (at Least One Intrauterine Gestational Sac With Fetal Heart Beat 5-6 Weeks After Transfer) Rate
Measured: 5-6 weeks after transfer
Implantation Rate
The implantation rate was defined as the number of gestational sacs 5-6 weeks after transfer divided by number of embryos transferred.
Measured: 5-6 weeks after transfer
Ongoing Pregnancy (at Least One Intrauterine Viable Fetus 10-11 Weeks After Transfer) Rate
Measured: 10-11 weeks after transfer
Ongoing Implantation Rate (Number of Intrauterine Viable Fetuses 10-11 Weeks After Transfer Divided by Number of Embryos Transferred)
The ongoing implantation rate was defined as the number of intrauterine viable fetuses 10-11 weeks after transfer divided by the number of embryos transferred.
Measured: 10-11 weeks after transfer
Early Ovarian Hyperstimulation Syndrome (OHSS), Late OHSS, and Total OHSS (All Overall and by Grade)
Early OHSS was defined as OHSS with onset ≤9 days after triggering of final follicular maturation. Late OHSS was defined as OHSS with onset >9 days after triggering of final follicular maturation. Total OHSS measure the incidence of OHSS both early and late.
Measured: ≤9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation until 21-28 days after last IMP dose or up to ongoing pregnancy 8-9 weeks after transfer in pregnant participants (late OHSS)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2023
- Study start29 Mar 2024
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infertility, FemaleStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 301 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
- NCT06173869
- Sponsor's protocol ID
- 000413
- Acronym
- COCO
- Status last verified
- Jan 2026
- First submitted
- 6 Dec 2023
- Last updated
- 12 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- 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 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial Comparing the Ovarian Response of a Starting Dose of Either 10 μg or 15 μg Follitropin Delta (FE 999049) to a Starting Dose of Either 150 IU or 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme in China
- ClinicalTrials.gov ID
- NCT06173869
- Acronym / sponsor ID
- COCO / 000413
- Conditions
- Infertility, Female
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 18 Dec 2023 (actual)
- Results
- Posted 12 Feb 2026
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 3b clinical trial with follitropin delta (FE 999049) and Gonal-F. The trial is a randomised, controlled, assessor-blind, parallel groups, multicentre trial comparing the ovarian response of a starting dose of either 10mg or 15 mg follitropin delta to a starting dose of either 150 IU or 225 IU Gonal-F in a long GnRH agonist protocol in women undergoing an assisted reproductive technology programme in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FE 999049 | Experimental | Drug: FE 999049The participants receive either low or high starting dose as appropriate according to Investigators Judgement. 10 or 15 µg |
| GONAL-F | Active comparator | Drug: GONAL-FThe participants receive either low or high starting dose as appropriate according to Investigators Judgement. 150 or 225 IU. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Signed and dated Informed Consent Form for participation in the trial, obtained before any trial-related procedures.
- In good physical and mental health in the judgement of the investigator.
- Chinese pre-menopausal female between the ages of 20 and 40 years; at least 20 years (including the 20th birthday) when signing the informed consent and no more than 40 years (up to the day before the 41st birthday) at the time of randomisation.
- Eligible for ovarian stimulation with a dose equivalent to 150 IU GONAL-F or 225 IU GONAL-F, as judged by the investigator.
- Body mass index (BMI) between 17.5 and 32.0 kg/m2 (both inclusive) at screening.
Key exclusion criteria (10 listed)
- Primary ovarian failure.
- More than three previous controlled ovarian stimulation cycles initiated, regardless of outcome.
- History of previous episode of OHSS, exuberant ovarian response to gonadotropins, or polycystic ovarian syndrome.
- Known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) which can compromise participation in the trial 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.
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 999049Also: Rekovelle, Follitropin DeltaFE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose could be increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants could be treated for a maximum of 20 days. | Drug | FE 999049 |
| GONAL-FGONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose could be increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants could be treated for a maximum of 20 days. Coasting was not allowed. | Drug | GONAL-F |
Primary outcome
Number of Oocytes Retrieved
Time frame: On day of oocyte retrieval (up to 22 days after start of stimulation)
15 secondary outcomes
Number of Follicles on Stimulation Day 6 and End-of-stimulation
Time frame: Stimulation day 6 and end-of-stimulation (maximum stimulation day 20)
Serum Concentrations of Estradiol on Stimulation Day 6 and End-of-stimulation
Time frame: stimulation day 6 and end-of-stimulation (maximum stimulation day 20)
Serum Concentrations of Progesterone on Stimulation Day 6 and End-of-stimulation
Time frame: stimulation day 6 and end-of-stimulation (maximum stimulation day 20)
Number of Fertilised Oocytes
Time frame: On day 1 after oocyte retrieval (up to 23 days after start of stimulation)
Fertilisation Rate
Time frame: On day 1 after oocyte retrieval (up to 23 days after start of stimulation)
Number of Embryos (Total and Quality)
Time frame: Day 3 after oocyte retrieval
Total Gonadotropin Dose
Time frame: Up to 20 stimulation days
Number of Stimulation Days
Time frame: Up to 20 stimulation days
Positive βhCG (Positive Serum βhCG Test 13-15 Days After Transfer) Rate
Time frame: 13-15 days after transfer
Clinical Pregnancy (at Least One Gestational Sac 5-6 Weeks After Transfer) Rate
Time frame: 5-6 weeks after transfer
Vital Pregnancy (at Least One Intrauterine Gestational Sac With Fetal Heart Beat 5-6 Weeks After Transfer) Rate
Time frame: 5-6 weeks after transfer
Implantation Rate
Time frame: 5-6 weeks after transfer
Ongoing Pregnancy (at Least One Intrauterine Viable Fetus 10-11 Weeks After Transfer) Rate
Time frame: 10-11 weeks after transfer
Ongoing Implantation Rate (Number of Intrauterine Viable Fetuses 10-11 Weeks After Transfer Divided by Number of Embryos Transferred)
Time frame: 10-11 weeks after transfer
Early Ovarian Hyperstimulation Syndrome (OHSS), Late OHSS, and Total OHSS (All Overall and by Grade)
Time frame: ≤9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation until 21-28 days after last IMP dose or up to ongoing pregnancy 8-9 weeks after transfer in pregnant participants (late OHSS)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FE 999049 and GONAL-F in people with Infertility, Female, run by Ferring Pharmaceuticals at 11 sites in China.
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 11 inclusion and 10 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 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Oocytes Retrieved (time frame: On day of oocyte retrieval (up to 22 days after start of stimulation)). 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 12 Feb 2026.