Prospective, Multi-centre, Non-Interventional Study to Investigate the Effectiveness of REKOVELLE® for Ovarian Stimulation for Asian Women in Real World Settings (PROFOUND)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Infertility
• Intervention / Treatment: Drug: REKOVELLE

• Study Type: Observational
• Enrollment (Estimated): 1500

Contacts and Locations

Study Locations

• Japan
  • Hiroshima, Japan, 7300035
    • Ferring Investigational Site
  • Hokkaido, Japan, 0600003
    • Ferring Investigational Site
  • Hyōgo, Japan, 6500021
    • Ferring Investigational Site
  • Osaka, Japan, 5300011
    • Ferring Investigational Site
  • Osaka, Japan, 5500015
    • Ferring Investigational Site
  • Saitama, Japan, 3540035
    • Ferring Investigational Site
  • Chiba
    • Chiba, Chiba, Japan, 2610023
      • Ferring Investigational Site
  • Fukuoka
    • Fukuoka, Fukuoka, Japan, 8120013
      • Ferring Investigational Site
    • Kitakyushu, Fukuoka, Japan, 8070825
      • Ferring Investigational Site
  • Gunma
    • Takasaki, Gunma, Japan, 3700841
      • Ferring Investigational Site
  • Hiroshima
    • Hiroshima, Hiroshima, Japan, 7320822
      • Ferring Investigational Site
  • Japan
    • Bunkyō City, Japan, Japan, 1130033
      • Ferring Investigational Site
  • Tokyo
    • Tokyo, Tokyo, Japan, 1600023
      • Ferring Investigational Site
• South Korea
  • Busan, South Korea, 47245
    • Ferring Investigational Site
  • Seoul, South Korea, 02586
    • Maria Fertility Hospital
  • Busan
    • Busan, Busan, South Korea, 49241
      • Ferring Investigational Site
  • Daegu
    • Daegu, Daegu, South Korea, 41910
      • Ferring Investigational Site
  • Seongnam
    • Seongnam-si, Seongnam, South Korea, 13496
      • Ferring Investigational Site
• Taiwan
  • Taichung, Taiwan, 406
    • Ferring Investigational Site
  • Taipei, Taiwan, 100225
    • Ferring Investigational Site
  • Taipei, Taiwan, 110
    • Ferring Investigational Site
  • Tainan
    • Tainan, Tainan, Taiwan, 70403
      • Ferring Investigational Site
    • Tainan, Tainan, Taiwan, 71004
      • Ferring Investigational Site
  • Taoyuan
    • Taoyuan District, Taoyuan, Taiwan, 333
      • Ferring Investigational Site
• Thailand
  • Bangkok, Thailand, 10700
    • Ferring Investigational Site
  • Muang
    • Phitsanulok, Muang, Thailand, 65000
      • Naresuan University Hospital
  • Ratchathewi
    • Bangkok, Ratchathewi, Thailand, 10400
      • Ramathibodi Hospital
• Vietnam
  • Hanoi
    • Hanoi, Hanoi, Vietnam, 100000
      • Ferring Investigational Site
  • Ho Chi Minh City
    • Ho Chi Minh City, Ho Chi Minh City, Vietnam, 700000
      • Ferring Investigational Site
    • Ho Chi Minh City, Ho Chi Minh City, Vietnam
      • Ferring Investigational Site
  • Huế
    • Huế, Huế, Vietnam, 49000
      • Ferring Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
REKOVELLE; Participants prescribed REKOVELLE for the first time for controlled ovarian stimulation.	Drug: REKOVELLE; Individualised dosing regiment of REKOVELLE in routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Luteinising hormone (LH) surge suppression protocol	Treatment pattern will be measured by analysing the Lutenising hormone (LH) surge suppression protocol.	Up to 22 days
Daily Dosage	Treatment pattern will be measured by analysing the REKOVELLE and concomitant ovarian stimulation protocols, consisting of daily dosage.	Up to 22 days
Stimulation Duration	Treatment pattern will be measured by analysing the REKOVELLE and concomitant ovarian stimulation protocols, consisting of stimulation duration.	Up to 22 days
Total Dosage	Treatment pattern will be measured by analysing the REKOVELLE and concomitant ovarian stimulation protocols, consisting of total dosage.	Up to 22 days
Trigger Protocol	Treatment pattern will be measured by analysing the trigger protocol.	Up to 22 days
Luteal phase support protocol	Treatment pattern will be measured by analysing the luteal phase support protocol.	Up to 22 days
Number of oocytes retrieved	Number of oocytes retrieved at oocyte retrieval	Up to 22 days
Number of Metaphase II (MII) oocytes	Number of MII oocytes at oocyte retrieval (only applicable for Intracytoplasmic sperm injection (ICSI))	Up to 22 days
Number of embryos	Number of embryos on Day 3 after oocyte retrieved	Day 3 after oocyte retrieval
Number of Blastocysts	Number of Blastocysts on Day 5 after oocyte retrieved	Day 5 after oocyte retrieval
Number of embryos transferred	Embryos transferred in fresh and/or frozen transfer cycles	Up to 28 days
Number of blastocysts transferred	Blastocysts transferred in fresh and/or frozen transfer cycles	Up to 28 days
Implantation rate	Number of gestational sacs, embryos or blastocysts transferred	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	11 to 15 days after transfer
Clinical Pregnancy rate	Clinical pregnancy rate (at least 1 gestational sac 4-5 weeks after transfer)	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)	4 to 5 weeks after transfer
Ongoing pregnancy rate	Ongoing pregnancy rate (at least 1 intrauterine viable fetus 9-11 weeks after transfer)	9 to 11 weeks after transfer
Time to pregnancy	Time to pregnancy from start date of ovarian stimulation to confirmation of clinical pregnancy	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.	More than 20 weeks after transfer
Multiple pregnancy rate	More than 1 gestational sac with fetal heart beat 4-5 weeks after transfer	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	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.	Up to 10-11 weeks after transfer
Estradiol Hormone levels	Estradiol hormone levels before stimulation and at the end of stimulation day	Up to 20 days
Progesterone Hormone levels	Progesterone hormone levels before stimulation and at the end of stimulation day	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)	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).	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	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)	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	During 1st cycle with REKOVELLE (each cycle range is 5-20 days, average 9 days), Up to 10-11 weeks after transfer

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals
• Investigators: Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: August 6, 2024
• First Submitted That Met QC Criteria: August 16, 2024
• First Posted (Actual): August 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: 000430

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No