Clinical trial NCT06561958: Prospective, Multi-centre, Non-Interventional Study to Investigate the Effectiveness of REKOVELLE® for Ovarian Stimulation for Asian Women in Real World Settings
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infertility
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2024-08-20
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Approximately 1500 patients prescribed REKOVELLE for the first time for controlled overian stimulation (COS) will be enrolled in the study.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Cumulative live birth rate
timeFrame: Up to 12 months
Secondary outcomes:
measure: The Luteinising hormone (LH) surge suppression protocol
timeFrame: Up to 22 days
measure: Daily Dosage
timeFrame: Up to 22 days
measure: Stimulation Duration
timeFrame: Up to 22 days
measure: Total Dosage
timeFrame: Up to 22 days
measure: Trigger Protocol
timeFrame: Up to 22 days
measure: Luteal phase support protocol
timeFrame: Up to 22 days
measure: Number of oocytes retrieved
timeFrame: Up to 22 days
measure: Number of Metaphase II (MII) oocytes
timeFrame: Up to 22 days
measure: Number of embryos
timeFrame: Day 3 after oocyte retrieval
measure: Number of Blastocysts
timeFrame: Day 5 after oocyte retrieval
measure: Number of embryos transferred
timeFrame: Up to 28 days
measure: Number of blastocysts transferred
timeFrame: Up to 28 days
measure: Implantation rate
timeFrame: Up to 28 days
measure: Positive human chorionic gonadotropin (hCG) rate
timeFrame: 11 to 15 days after transfer
measure: Clinical Pregnancy rate
timeFrame: 4 to 5 weeks after transfer
measure: Vital Pregnancy
timeFrame: 4 to 5 weeks after transfer
measure: Ongoing pregnancy rate
timeFrame: 9 to 11 weeks after transfer
measure: Time to pregnancy
timeFrame: 4 to 5 weeks after transfer
measure: Live birth rate
timeFrame: More than 20 weeks after transfer
measure: Multiple pregnancy rate
timeFrame: 4 to 5 weeks after transfer
measure: Spontaneous abortion rate
timeFrame: Up to 10-11 weeks after transfer
measure: Ectopic pregnancy rate
timeFrame: Up to 10-11 weeks after transfer
measure: Estradiol Hormone levels
timeFrame: Up to 20 days
measure: Progesterone Hormone levels
timeFrame: Up to 20 days
measure: Cycle cancellation rate and the reason for cycle cancellation
timeFrame: Up to 28 days
measure: Transfer cancellation rate and the reason for transfer cancellation
timeFrame: Up to 28 days
measure: Frequency and severity of adverse drug reactions (ADRs) and serious adverse events (SAEs)
timeFrame: During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after transfer
measure: Preventive interventions for ovarian hyperstimulation syndrome (OHSS)
timeFrame: During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after transfer.
measure: Number of subjects with mild / moderate / severe ovarian hyperstimulation syndrome (OHSS)
timeFrame: During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after transfer
Other outcomes:
Locations:
city: Kitakyushu
country: Japan
facility: Ferring Investigational Site
state: Fukuoka
city: Takasaki
country: Japan
facility: Ferring Investigational Site
state: Gunma
city: Bunkyō-Ku
country: Japan
facility: Ferring Investigational Site
city: Chiba
country: Japan
facility: Ferring Investigational Site
city: Fukuoka
country: Japan
facility: Ferring Investigational Site
city: Hiroshima
country: Japan
facility: Ferring Investigational Site
city: Hiroshima
country: Japan
facility: Ferring Investigational Site
city: Hokkaido
country: Japan
facility: Ferring Investigational Site
city: Hyōgo
country: Japan
facility: Ferring Investigational Site
city: Osaka
country: Japan
facility: Ferring Investigational Site
city: Osaka
country: Japan
facility: Ferring Investigational Site
city: Saitama
country: Japan
facility: Ferring Investigational Site
city: Tokyo
country: Japan
facility: Ferring Investigational Site
city: Seongnam-si
country: Korea, Republic of
facility: Ferring Investigational Site
state: Seongnam
city: Busan
country: Korea, Republic of
facility: Ferring Investigational Site
city: Busan
country: Korea, Republic of
facility: Ferring Investigational Site
city: Daegu
country: Korea, Republic of
facility: Ferring Investigational Site
city: Taichung City
country: Taiwan
facility: Ferring Investigational Site
city: Tainan
country: Taiwan
facility: Ferring Investigational Site
city: Tainan
country: Taiwan
facility: Ferring Investigational Site
city: Taipei
country: Taiwan
facility: Ferring Investigational Site
city: Taipei
country: Taiwan
facility: Ferring Investigational Site
city: Taoyuan
country: Taiwan
facility: Ferring Investigational Site
city: Bangkok
country: Thailand
facility: Ferring Investigational Site
city: Hanoi
country: Vietnam
facility: Ferring Investigational Site
city: Ho Chi Minh City
country: Vietnam
facility: Ferring Investigational Site
city: Ho Chi Minh City
country: Vietnam
facility: Ferring Investigational Site
city: Huế
country: Vietnam
facility: Ferring Investigational Site
Study officials:
affiliation: Ferring Pharmaceuticals
name: Global Clinical Compliance
role: STUDY_DIRECTOR
References: