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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Live Birth Rate per initiated stimulation cycles | Up to 15 months |
| Measure | Description | Time Frame |
|---|---|---|
| Serum oestradiol levels | Serum oestradiol levels on days of stimulation initiation (before treatment) and at end-of-stimulation | Up to 20 days |
| Progesterone (P4) levels | Progesterone (P4) levels on days of stimulation initiation (before treatment) and at end-of-stimulation |
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Inclusion Criteria:
Women who meet all the following criteria are eligible for participation:
Exclusion Criteria:
Women who meet any of the following criteria are not eligible for participation:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Compliance | Contact | +1 862-286-5200 | Disclosure@ferring.com |
| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Compliance | Ferring Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Anhui Medical University | Recruiting | Hefei | Anhui | 230088 | China | |
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| Up to 20 days |
| Cycle cancellation rate and reasons for cycle cancellation | Up to 28 days |
| Number of oocytes retrieved | Up to 22 days |
| Number of metaphase II (MII) oocytes | Number of metaphase II (MII) oocytes for intracytoplasmic sperm injection (ICSI) | Up to 22 days |
| Number of embryos on Day 3 after oocyte retrieval | Day 3 after oocyte retrieval |
| Number of embryos on Day 5 after oocyte retrieval | Day 5 after oocyte retrieval |
| Number of transferred embryos | Up to 28 days |
| Number of transferred blastocysts | Up to 28 days |
| Transfer cancellation rate and reasons for transfer cancellation | Up to 28 days |
| Implantation rate | Number of gestational sacs, embryos or blastocysts transferred | Up to 28 days |
| Positive beta-human chorionic gonadotropin (βhCG) test rate | 11-15 days after transfer |
| Clinical pregnancy rate | At least one intrauterine gestational sac 4-6 weeks after transfer | 4 to 6 weeks after transfer |
| Vital pregnancy rate | At least 1 intrauterine gestational sac with fetal heartbeat 4-6 weeks after transfer | 4 to 6 weeks after transfer |
| Ongoing pregnancy rate | At least 1 intrauterine viable fetus 9-11 weeks after transfer | 9 to 11 weeks after transfer |
| Cumulative ongoing pregnancy rate | 9 to 11 days |
| Time to pregnancy | Time to pregnancy from stimulation initiation to ongoing pregnancy | 4 to 6 weeks after transfer |
| Pregnancy loss rate | Up to 10 - 11 weeks after transfer |
| Live birth rate per initiated stimulation cycles with fresh transfer cycles | More than 20 weeks after transfer |
| Cumulative live birth rate per initiated stimulation cycles | More than 20 weeks after transfer |
| Frequency and severity of adverse drug reactions | 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) | 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 | Up to 9 days after triggering of final follicular maturation |
| Frequency of late OHSS | Up to 10-11 weeks after transfer |
| Use of luteinising hormone (LH) surge suppression protocols | Up to 22 days |
| Daily dose of REKOVELLE | Use of REKOVELLE protocol, including daily dose | Up to 22 days |
| Total dose of REKOVELLE | Use of REKOVELLE protocol including total dose | Up to 22 days |
| Stimulation duration | Stimulation duration following use of REKOVELLE protocol | Up to 22 days |
| Use of any other concomitant ovarian stimulation agent, including daily dose, total dose, and stimulation duration | Up to 22 days |
| Use of follicle maturation triggering protocol | Up to 22 days |
| Maanshan Maternal and Child Health Care Hospital |
| Recruiting |
| Ma’anshan |
| Anhui |
| 243031 |
| China |
| Beijing Obstetrics And Gynecology Hospital Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100006 | China |
| Beijing Chaoyang Hospital (Beijing) | Recruiting | Chaoyang | Beijing Municipality | 100020 | China |
| Peking University First Hospital | Recruiting | Xicheng | Beijing Municipality | 100034 | China |
| 6th Affiliated Hospital of Sun Yat Sen University | Recruiting | Guangzhou | Guandong | 510655 | China |
| 3rd Affiliated Hospital of Guangzhou Medical University (Guangzhou) | Recruiting | Guangzhou | Guangdong | 510000 | China |
| The First Affiliated Hospital of Shantou University Medical College | Recruiting | Shantou | Guangdong | 515041 | China |
| The Second Nanning People's Hospital | Recruiting | Nanning | Guangxi | 530000 | China |
| Tongji Hospital Tongji Medical College of Hust | Recruiting | Wuhan | Hubei | 430034 | China |
| Hubei Maternal and Child Health Hospital | Recruiting | Wuhan | Hubei | 430070 | China |
| Reproductive & Genetic hospital Of CITIC-Xiangya | Recruiting | Changsha | Hunan | 410008 | China |
| 1st Affiliated Hospital of Nanchang University | Recruiting | Nanchang | Jiangxi | 330006 | China |
| General Hospital of Ningxia Medical University | Recruiting | Yinchuan | Ningxia | 750004 | China |
| The Second Affiliated Hospital of Air Force Medical University | Recruiting | Xi'an | Shaanxi | 710038 | China |
| Binzhou Medical University Hospital | Recruiting | Binzhou | Shandong | 256600 | China |
| Reproductive Hospital Affiliated to Shandong University | Recruiting | Jinan | Shandong | 250001 | China |
| Affiliated Hospital of Jining Medical University | Recruiting | Jining | Shandong | 272001 | China |
| Shanghai First Maternal and Child Health Hospital | Recruiting | Shanghai | Shanghai Municipality | 201204 | China |
| Northwest Women's and Children's Hospital | Recruiting | Xi’an | Shanxi | 710061 | China |
| Tianjin Medical University General Hospital (Heping District) | Recruiting | Xiaobailou | Tianjin Municipality | 300052 | China |
| Women's hospital School of Medicine Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310006 | China |
| Peking University Third Hospital (Beijing) | Recruiting | Beijing | 100191 | China |
| Zhejiang Provincial People's Hospital | Recruiting | Hangzhou | 310014 | China |
| Jinhua People's Hospital | Recruiting | Jinhua | 321022 | China |
| The Peoples Hospital of Guangxi Zhuang Autonomous Region | Recruiting | Nanning | 530021 | China |
| The Reproduction Hospital of Guangxi Zhuang Autonomous Region | Recruiting | Nanning | 530022 | China |
| Zhongshan Hospital Affiliated to Fudan University | Recruiting | Shanghai | 200032 | China |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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