InfertilityLYCHEENCT07029451
To Investigate REKOVELLE in Chinese Women Undergoing Assisted Reproductive Technologies: Effectiveness, Safety, and Patterns of Use in Real-world Practice
An observational study of Infertility, run by Ferring Pharmaceuticals at 28 sites in China.
Trial summary
This is a multi-centre prospective non-interventional trial to assess the pattern of use of REKOVELLE® in Women Undergoing In Vitro Fertilisation (IVF) or Intracytoplasmic Sperm Injection (ICSI) Procedures in Routine Clinical Practice. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Infertility
- How many people
- 2,549 participants
- Where
- 28 sitesChina
- Study dates
- 5 Aug 2025to 30 Sep 2028
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Women eligible for enrolment in the study are those scheduled for their first REKOVELLE treatment, with no more than one prior COS cycle for IVF or ICSI, and who meet the inclusion and exclusion criteria. Data from approximately 2,500 patients will be collected.
Who may be able to join
- Women who meet all the following criteria are eligible for participation:
- At least 20 years of age (including the 20th birthday) when signing informed consent
- Prescribed REKOVELLE for the first time in controlled ovarian stimulation for in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycles
- Willing and able to provide written informed consent
Who cannot join
- Women who meet any of the following criteria are not eligible for participation:
- Previously undergone more than 1 controlled ovarian stimulation cycles for IVF or ICSI
- Currently participating in an interventional clinical study for which treatment with medication is mandated
- Currently undergoing ovarian stimulation for fertility preservation or oocytes donation
- Contraindications for the use of REKOVELLE
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
China28 sites
Beijing Obstetrics And Gynecology Hospital Capital Medical University
Beijing, Beijing Municipality, 100006
Peking University Third Hospital (Beijing)
Beijing, 100191
Binzhou Medical University Hospital
Binzhou, Shandong, 256600
Reproductive & Genetic hospital Of CITIC-Xiangya
Changsha, Hunan, 410008
Beijing Chaoyang Hospital (Beijing)
Chaoyang, Beijing Municipality, 100020
6th Affiliated Hospital of Sun Yat Sen University
Guangzhou, Guandong, 510655
3rd Affiliated Hospital of Guangzhou Medical University (Guangzhou)
Guangzhou, Guangdong, 510000
Women's hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang, 310006
Zhejiang Provincial People's Hospital
Hangzhou, 310014
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230088
Reproductive Hospital Affiliated to Shandong University
Jinan, Shandong, 250001
Jinhua People's Hospital
Jinhua, 321022
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272001
Maanshan Maternal and Child Health Care Hospital
Ma’anshan, Anhui, 243031
1st Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
The Second Nanning People's Hospital
Nanning, Guangxi, 530000
The Peoples Hospital of Guangxi Zhuang Autonomous Region
Nanning, 530021
The Reproduction Hospital of Guangxi Zhuang Autonomous Region
Nanning, 530022
Shanghai First Maternal and Child Health Hospital
Shanghai, Shanghai Municipality, 201204
Zhongshan Hospital Affiliated to Fudan University
Shanghai, 200032
The First Affiliated Hospital of Shantou University Medical College
Shantou, Guangdong, 515041
Tongji Hospital Tongji Medical College of Hust
Wuhan, Hubei, 430034
Hubei Maternal and Child Health Hospital
Wuhan, Hubei, 430070
The Second Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, 710038
Northwest Women's and Children's Hospital
Xi’an, Shanxi, 710061
Tianjin Medical University General Hospital (Heping District)
Xiaobailou, Tianjin Municipality, 300052
Peking University First Hospital
Xicheng, Beijing Municipality, 100034
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
About this study
Official title: Prospective, Post-authorisation, Multi-centre, Non-interventional Study to Investigate REKOVELLE in Chinese Women Undergoing Assisted Reproductive Technologies: Effectiveness, Safety, and Patterns of Use in Real-world Practice
This is a multi-centre prospective non-interventional trial to assess the pattern of use of REKOVELLE® in Women Undergoing In Vitro Fertilisation (IVF) or Intracytoplasmic Sperm Injection (ICSI) Procedures in Routine Clinical Practice.
There will be approximately 2500 patients initiated with REKOVELLE® treatment and enrolled in 30-50 sites in China. The total duration of the study will be approximately 35 months.
- Conditions
- Infertility
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Live Birth Rate per initiated stimulation cycles
Measured: Up to 15 months
Secondary outcomes (30)
Serum oestradiol levels
Serum oestradiol levels on days of stimulation initiation (before treatment) and at end-of-stimulation
Measured: Up to 20 days
Progesterone (P4) levels
Progesterone (P4) levels on days of stimulation initiation (before treatment) and at end-of-stimulation
Measured: Up to 20 days
Cycle cancellation rate and reasons for cycle cancellation
Measured: Up to 28 days
Number of oocytes retrieved
Measured: Up to 22 days
Number of metaphase II (MII) oocytes
Number of metaphase II (MII) oocytes for intracytoplasmic sperm injection (ICSI)
Measured: Up to 22 days
Number of embryos on Day 3 after oocyte retrieval
Measured: Day 3 after oocyte retrieval
Number of embryos on Day 5 after oocyte retrieval
Measured: Day 5 after oocyte retrieval
Number of transferred embryos
Measured: Up to 28 days
Number of transferred blastocysts
Measured: Up to 28 days
Transfer cancellation rate and reasons for transfer cancellation
Measured: Up to 28 days
Implantation rate
Number of gestational sacs, embryos or blastocysts transferred
Measured: Up to 28 days
Positive beta-human chorionic gonadotropin (βhCG) test rate
Measured: 11-15 days after transfer
Clinical pregnancy rate
At least one intrauterine gestational sac 4-6 weeks after transfer
Measured: 4 to 6 weeks after transfer
Vital pregnancy rate
At least 1 intrauterine gestational sac with fetal heartbeat 4-6 weeks after transfer
Measured: 4 to 6 weeks after transfer
Ongoing pregnancy rate
At least 1 intrauterine viable fetus 9-11 weeks after transfer
Measured: 9 to 11 weeks after transfer
Cumulative ongoing pregnancy rate
Measured: 9 to 11 days
Time to pregnancy
Time to pregnancy from stimulation initiation to ongoing pregnancy
Measured: 4 to 6 weeks after transfer
Pregnancy loss rate
Measured: Up to 10 - 11 weeks after transfer
Live birth rate per initiated stimulation cycles with fresh transfer cycles
Measured: More than 20 weeks after transfer
Cumulative live birth rate per initiated stimulation cycles
Measured: More than 20 weeks after transfer
Frequency and severity of adverse drug reactions
Measured: During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after transfer
Frequency of preventive interventions for early ovarian hyperstimulation syndrome (OHSS)
Measured: During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after transfer
Frequency of early OHSS
Measured: Up to 9 days after triggering of final follicular maturation
Frequency of late OHSS
Measured: Up to 10-11 weeks after transfer
Use of luteinising hormone (LH) surge suppression protocols
Measured: Up to 22 days
Daily dose of REKOVELLE
Use of REKOVELLE protocol, including daily dose
Measured: Up to 22 days
Total dose of REKOVELLE
Use of REKOVELLE protocol including total dose
Measured: Up to 22 days
Stimulation duration
Stimulation duration following use of REKOVELLE protocol
Measured: Up to 22 days
Use of any other concomitant ovarian stimulation agent, including daily dose, total dose, and stimulation duration
Measured: Up to 22 days
Use of follicle maturation triggering protocol
Measured: Up to 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study start5 Aug 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (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
- 2,549 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
- NCT07029451
- Sponsor's protocol ID
- 000442
- Acronym
- LYCHEE
- Status last verified
- Sep 2026
- First submitted
- 10 Jun 2025
- Last updated
- 25 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 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Post-authorisation, Multi-centre, Non-interventional Study to Investigate REKOVELLE in Chinese Women Undergoing Assisted Reproductive Technologies: Effectiveness, Safety, and Patterns of Use in Real-world Practice
- ClinicalTrials.gov ID
- NCT07029451
- Acronym / sponsor ID
- LYCHEE / 000442
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,549 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 19 Jun 2025 (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 multi-centre prospective non-interventional trial to assess the pattern of use of REKOVELLE® in Women Undergoing In Vitro Fertilisation (IVF) or Intracytoplasmic Sperm Injection (ICSI) Procedures in Routine Clinical Practice.
There will be approximately 2500 patients initiated with REKOVELLE® treatment and enrolled in 30-50 sites in China. The total duration of the study will be approximately 35 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women eligible for enrolment in the study are those scheduled for their first REKOVELLE treatment, with no more than one prior COS cycle for IVF or ICSI, and who meet the inclusion and exclusion criteria. Data from approximately 2,500 patients will be collected.
Key inclusion criteria (4 listed)
- Women who meet all the following criteria are eligible for participation:
Key exclusion criteria (5 listed)
- Women who meet any of the following criteria are not eligible for participation:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Live Birth Rate per initiated stimulation cycles
Time frame: Up to 15 months
30 secondary outcomes
Serum oestradiol levels
Time frame: Up to 20 days
Progesterone (P4) levels
Time frame: Up to 20 days
Cycle cancellation rate and reasons for cycle cancellation
Time frame: Up to 28 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 on Day 3 after oocyte retrieval
Time frame: Day 3 after oocyte retrieval
Number of embryos on Day 5 after oocyte retrieval
Time frame: Day 5 after oocyte retrieval
Number of transferred embryos
Time frame: Up to 28 days
Number of transferred blastocysts
Time frame: Up to 28 days
Transfer cancellation rate and reasons for transfer cancellation
Time frame: Up to 28 days
Implantation rate
Time frame: Up to 28 days
Positive beta-human chorionic gonadotropin (βhCG) test rate
Time frame: 11-15 days after transfer
Clinical pregnancy rate
Time frame: 4 to 6 weeks after transfer
Vital pregnancy rate
Time frame: 4 to 6 weeks after transfer
Ongoing pregnancy rate
Time frame: 9 to 11 weeks after transfer
Cumulative ongoing pregnancy rate
Time frame: 9 to 11 days
Time to pregnancy
Time frame: 4 to 6 weeks after transfer
Pregnancy loss rate
Time frame: Up to 10 - 11 weeks after transfer
Live birth rate per initiated stimulation cycles with fresh transfer cycles
Time frame: More than 20 weeks after transfer
Cumulative live birth rate per initiated stimulation cycles
Time frame: More than 20 weeks after transfer
Frequency and severity of adverse drug reactions
Time frame: During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after transfer
Frequency of preventive interventions for early 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
Frequency of early OHSS
Time frame: Up to 9 days after triggering of final follicular maturation
Frequency of late OHSS
Time frame: Up to 10-11 weeks after transfer
Use of luteinising hormone (LH) surge suppression protocols
Time frame: Up to 22 days
Daily dose of REKOVELLE
Time frame: Up to 22 days
Total dose of REKOVELLE
Time frame: Up to 22 days
Stimulation duration
Time frame: Up to 22 days
Use of any other concomitant ovarian stimulation agent, including daily dose, total dose, and stimulation duration
Time frame: Up to 22 days
Use of follicle maturation triggering protocol
Time frame: Up to 22 days
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 25 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
28 sites in 1 country: 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 28 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 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 25 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 28 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.
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?
Live Birth Rate per initiated stimulation cycles (time frame: Up to 15 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 25 Sep 2026.