InfertilityPROFOUNDNCT06561958
Prospective, Multi-centre, Non-Interventional Study to Investigate the Effectiveness of REKOVELLE® for Ovarian Stimulation for Asian Women in Real World Settings
An observational study of Infertility, run by Ferring Pharmaceuticals at 31 sites in 5 countries.
Trial summary
Primary objective is to investigate the effectiveness of REKOVELLE® in women undergoing their first REKOVELLE® ovarian stimulation treatment in real world practice in Asian countries. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Infertility
- What is being tested?
- REKOVELLE
- How many people
- 1,526 participants
- Where
- 31 sitesin 5 countries
- Study dates
- 27 Aug 2024to 1 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Adult, Older adult
Study population: Approximately 1500 patients prescribed REKOVELLE for the first time for controlled overian stimulation (COS) will be enrolled in the study.
Who may be able to join
- Females aged 20 years or older at enrollment
- Serum AMH level >0.5 ng / mL (with the latest result tested within 12 months)
- Who are first time prescribed REKOVELLE for their ovarian stimulation and IVF or ICSI treatment cycle using fresh or frozen ejaculated sperm from male partner or sperm donor (if applicable)
- Willing and able to provide written informed consent
Who cannot join
- Have undergone more than 2 COS-IVF / ICSI cycles before the enrollment
- Participating in an interventional clinical trial in which any medication treatment is mandated
- Women with a contraindication for prescription of REKOVELLE treatment
- Oocyte donors
- Undergoing ovarian stimulation for fertility preservation
Trial locations and contacts
31 sites in 5 countries.
31 sites in 5 countries
Japan13 sites
Ferring Investigational Site
Bunkyō City, Japan, 1130033
Ferring Investigational Site
Chiba, Chiba, 2610023
Ferring Investigational Site
Fukuoka, Fukuoka, 8120013
Ferring Investigational Site
Hiroshima, Hiroshima, 7320822
Ferring Investigational Site
Hiroshima, 7300035
Ferring Investigational Site
Hokkaido, 0600003
Ferring Investigational Site
Hyōgo, 6500021
Ferring Investigational Site
Kitakyushu, Fukuoka, 8070825
Ferring Investigational Site
Osaka, 5300011
Ferring Investigational Site
Osaka, 5500015
Ferring Investigational Site
Saitama, 3540035
Ferring Investigational Site
Takasaki, Gunma, 3700841
Ferring Investigational Site
Tokyo, Tokyo, 1600023
Taiwan6 sites
Ferring Investigational Site
Taichung, 406
Ferring Investigational Site
Tainan, Tainan, 70403
Ferring Investigational Site
Tainan, Tainan, 71004
Ferring Investigational Site
Taipei, 100225
Ferring Investigational Site
Taipei, 110
Ferring Investigational Site
Taoyuan, Taoyuan, 333
South Korea5 sites
Ferring Investigational Site
Busan, Busan, 49241
Ferring Investigational Site
Busan, 47245
Ferring Investigational Site
Daegu, Daegu, 41910
Ferring Investigational Site
Seongnam-si, Seongnam, 13496
Maria Fertility Hospital
Seoul, 02586
Vietnam4 sites
Ferring Investigational Site
Hanoi, Hanoi, 100000
Ferring Investigational Site
Ho Chi Minh City, Ho Chi Minh City, 700000
Ferring Investigational Site
Ho Chi Minh City, Ho Chi Minh City
Ferring Investigational Site
Huế, Huế, 49000
Thailand3 sites
Ramathibodi Hospital
Bangkok, Ratchathewi, 10400
Ferring Investigational Site
Bangkok, 10700
Naresuan University Hospital
Phitsanulok, Muang, 65000
About this study
Official title: Prospective, Multi-country, Non-Interventional Study to Investigate REKOVELLE for Ovarian Stimulation: the Effectiveness, Safety, and Patterns Of Use for Asian Women in Real World Practice
Primary objective is to investigate the effectiveness of REKOVELLE® in women undergoing their first REKOVELLE® ovarian stimulation treatment in real world practice in Asian countries.
- Conditions
- Infertility
- Being tested
- REKOVELLE
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REKOVELLEDrug
Individualised dosing regiment of REKOVELLE in routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| REKOVELLE | Participants prescribed REKOVELLE for the first time for controlled ovarian stimulation. Receives: Drug: REKOVELLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative live birth rate
Cumulative live birth rate defined as delivery of at least 1 live fetus after 20 completed weeks of gestation, combined fresh and frozen embryo transfers within 12 months after the start of the ovarian stimulation in patients of the first REKOVELLE ovarian stimulation cycle.
Measured: Up to 12 months
Secondary outcomes (29)
The Luteinising hormone (LH) surge suppression protocol
Treatment pattern will be measured by analysing the Lutenising hormone (LH) surge suppression protocol.
Measured: Up to 22 days
Daily Dosage
Treatment pattern will be measured by analysing the REKOVELLE and concomitant ovarian stimulation protocols, consisting of daily dosage.
Measured: Up to 22 days
Stimulation Duration
Treatment pattern will be measured by analysing the REKOVELLE and concomitant ovarian stimulation protocols, consisting of stimulation duration.
Measured: Up to 22 days
Total Dosage
Treatment pattern will be measured by analysing the REKOVELLE and concomitant ovarian stimulation protocols, consisting of total dosage.
Measured: Up to 22 days
Trigger Protocol
Treatment pattern will be measured by analysing the trigger protocol.
Measured: Up to 22 days
Luteal phase support protocol
Treatment pattern will be measured by analysing the luteal phase support protocol.
Measured: Up to 22 days
Number of oocytes retrieved
Number of oocytes retrieved at oocyte retrieval
Measured: Up to 22 days
Number of Metaphase II (MII) oocytes
Number of MII oocytes at oocyte retrieval (only applicable for Intracytoplasmic sperm injection (ICSI))
Measured: Up to 22 days
Number of embryos
Number of embryos on Day 3 after oocyte retrieved
Measured: Day 3 after oocyte retrieval
Number of Blastocysts
Number of Blastocysts on Day 5 after oocyte retrieved
Measured: Day 5 after oocyte retrieval
Number of embryos transferred
Embryos transferred in fresh and/or frozen transfer cycles
Measured: Up to 28 days
Number of blastocysts transferred
Blastocysts transferred in fresh and/or frozen transfer cycles
Measured: Up to 28 days
Implantation rate
Number of gestational sacs, embryos or blastocysts transferred
Measured: Up to 28 days
Positive human chorionic gonadotropin (hCG) rate
Positive human chorionic gonadotropin (hCG) rate analysed using serum or urine hCG test 11-15 days after transfer
Measured: 11 to 15 days after transfer
Clinical Pregnancy rate
Clinical pregnancy rate (at least 1 gestational sac 4-5 weeks after transfer)
Measured: 4 to 5 weeks after transfer
Vital Pregnancy
Vital pregnancy rate (at least 1 intrauterine gestational sac with fetal heartbeat 4-5 weeks after transfer)
Measured: 4 to 5 weeks after transfer
Ongoing pregnancy rate
Ongoing pregnancy rate (at least 1 intrauterine viable fetus 9-11 weeks after transfer)
Measured: 9 to 11 weeks after transfer
Time to pregnancy
Time to pregnancy from start date of ovarian stimulation to confirmation of clinical pregnancy
Measured: 4 to 5 weeks after transfer
Live birth rate
Live birth is defined as delivery of at least 1 live fetus after 20 completed weeks of gestation within 12 months after the start of the ovarian stimulation in patients of the first REKOVELLE ovarian stimulation cycle.
Measured: More than 20 weeks after transfer
Multiple pregnancy rate
More than 1 gestational sac with fetal heart beat 4-5 weeks after transfer
Measured: 4 to 5 weeks after transfer
Spontaneous abortion rate
Spontaneous abortion is defined as positive hCG test but all intrauterine gestational sacs without fetal heart beat as documented by ultrasound, or there are no viable fetuses observed by ultrasound
Measured: Up to 10-11 weeks after transfer
Ectopic pregnancy rate
Ectopic pregnancy is defined as extrauterine gestational sac with or without fetal heart beat as documented by ultrasound or surgery.
Measured: Up to 10-11 weeks after transfer
Estradiol Hormone levels
Estradiol hormone levels before stimulation and at the end of stimulation day
Measured: Up to 20 days
Progesterone Hormone levels
Progesterone hormone levels before stimulation and at the end of stimulation day
Measured: Up to 20 days
Cycle cancellation rate and the reason for cycle cancellation
Date when the investigator decides to cancel cycle before oocyte pick up (due to poor ovarian response, excessive ovarian response, any illness which prevents oocyte collection procedure, subject not taking hCG injection at the correct time, subject choice, other) or after oocyte pick-up (due to no oocytes collected, no oocytes fertilized, abnormal fertilization, abnormal embryo development, no embryo development, ovarian hyperstimulation syndrome (OHSS), subject choice, any other specified reason)
Measured: Up to 28 days
Transfer cancellation rate and the reason for transfer cancellation
Transfer cancellation rate and the reason for transfer cancellation (no embryo available for transfer, risk of OHSS, endometrium not receptive, high progesterone level, adverse event, any other specified reason for transfer cancellation).
Measured: Up to 28 days
Frequency and severity of adverse drug reactions (ADRs) and serious adverse events (SAEs)
Frequency and severity of ADRs and SAEs as defined by the investigator
Measured: During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after transfer
Preventive interventions for ovarian hyperstimulation syndrome (OHSS)
Preventive interventions decided by the investigator (Triggering of final follicular maturation with GnRH agonist and fresh embryo/blastocyst transfer or cryopreservation, Cancellation of fresh embryo/blastocyst transfer)
Measured: During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after transfer.
Number of subjects with mild / moderate / severe ovarian hyperstimulation syndrome (OHSS)
Number of subjects with mild / moderate / severe OHSS, defined by the investigator
Measured: During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 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 posted20 Aug 2024
- Study start27 Aug 2024
- Primary completion1 May 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,526 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
- NCT06561958
- Sponsor's protocol ID
- 000430
- Acronym
- PROFOUND
- Status last verified
- Sep 2026
- First submitted
- 6 Aug 2024
- Last updated
- 30 Sep 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 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-country, Non-Interventional Study to Investigate REKOVELLE for Ovarian Stimulation: the Effectiveness, Safety, and Patterns Of Use for Asian Women in Real World Practice
- ClinicalTrials.gov ID
- NCT06561958
- Acronym / sponsor ID
- PROFOUND / 000430
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,526 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 20 Aug 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.
Primary objective is to investigate the effectiveness of REKOVELLE® in women undergoing their first REKOVELLE® ovarian stimulation treatment in real world practice in Asian countries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| REKOVELLE | – | Drug: REKOVELLEParticipants prescribed REKOVELLE for the first time for controlled ovarian stimulation. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Approximately 1500 patients prescribed REKOVELLE for the first time for controlled overian stimulation (COS) will be enrolled in the study.
Key inclusion criteria (4 listed)
- Females aged 20 years or older at enrollment
- Serum AMH level >0.5 ng / mL (with the latest result tested within 12 months)
- Who are first time prescribed REKOVELLE for their ovarian stimulation and IVF or ICSI treatment cycle using fresh or frozen ejaculated sperm from male partner or sperm donor (if applicable)
- Willing and able to provide written informed consent
Key exclusion criteria (5 listed)
- Have undergone more than 2 COS-IVF / ICSI cycles before the enrollment
- Participating in an interventional clinical trial in which any medication treatment is mandated
- Women with a contraindication for prescription of REKOVELLE treatment
- Oocyte donors
- Undergoing ovarian stimulation for fertility preservation
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 |
|---|---|---|
| REKOVELLEIndividualised dosing regiment of REKOVELLE in routine clinical practice. | Drug | REKOVELLE |
Primary outcome
Cumulative live birth rate
Time frame: Up to 12 months
Cumulative live birth rate defined as delivery of at least 1 live fetus after 20 completed weeks of gestation, combined fresh and frozen embryo transfers within 12 months after the start of the ovarian stimulation in patients of the first REKOVELLE ovarian stimulation cycle.
29 secondary outcomes
The Luteinising hormone (LH) surge suppression protocol
Time frame: Up to 22 days
Daily Dosage
Time frame: Up to 22 days
Stimulation Duration
Time frame: Up to 22 days
Total Dosage
Time frame: Up to 22 days
Trigger Protocol
Time frame: Up to 22 days
Luteal phase support protocol
Time frame: Up to 22 days
Number of oocytes retrieved
Time frame: Up to 22 days
Number of Metaphase II (MII) oocytes
Time frame: Up to 22 days
Number of embryos
Time frame: Day 3 after oocyte retrieval
Number of Blastocysts
Time frame: Day 5 after oocyte retrieval
Number of embryos transferred
Time frame: Up to 28 days
Number of blastocysts transferred
Time frame: Up to 28 days
Implantation rate
Time frame: Up to 28 days
Positive human chorionic gonadotropin (hCG) rate
Time frame: 11 to 15 days after transfer
Clinical Pregnancy rate
Time frame: 4 to 5 weeks after transfer
Vital Pregnancy
Time frame: 4 to 5 weeks after transfer
Ongoing pregnancy rate
Time frame: 9 to 11 weeks after transfer
Time to pregnancy
Time frame: 4 to 5 weeks after transfer
Live birth rate
Time frame: More than 20 weeks after transfer
Multiple pregnancy rate
Time frame: 4 to 5 weeks after transfer
Spontaneous abortion rate
Time frame: Up to 10-11 weeks after transfer
Ectopic pregnancy rate
Time frame: Up to 10-11 weeks after transfer
Estradiol Hormone levels
Time frame: Up to 20 days
Progesterone Hormone levels
Time frame: Up to 20 days
Cycle cancellation rate and the reason for cycle cancellation
Time frame: Up to 28 days
Transfer cancellation rate and the reason for transfer cancellation
Time frame: Up to 28 days
Frequency and severity of adverse drug reactions (ADRs) and serious adverse events (SAEs)
Time frame: During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after transfer
Preventive interventions for ovarian hyperstimulation syndrome (OHSS)
Time frame: During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after transfer.
Number of subjects with mild / moderate / severe ovarian hyperstimulation syndrome (OHSS)
Time frame: During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after transfer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 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
31 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Ferring Pharmaceuticals at 31 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 4 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Japan, Taiwan, South Korea, Vietnam, Thailand. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Cumulative live birth rate (time frame: Up to 12 months). 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 Sep 2026.