Status:
COMPLETED
A Trial to Compare the Ovarian Response of REKOVELLE and GONAL-F in Conventional Dosing in Women Undergoing Controlled Ovarian Stimulation
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Infertility
Eligibility:
FEMALE
18-40 years
Phase:
PHASE3
Brief Summary
Hormone preparations like REKOVELLE and GONAL-F are used to make the body produce multiple egg sacs, allowing more eggs to be collected from women undergoing infertility treatment. The main purpose o...
Eligibility Criteria
Inclusion
- Infertile women aged 18-40 years
- Diagnosed with tubal infertility, unexplained infertility, mild endometriosis (stage I/II) or partners with decreased sperm quality
- Medically eligible for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI)
- Infertility for at least one year for participants ≤ 37 years or for at least 6 months for participants ≥ 38 years
- Regular menstrual cycles of 21-35 days.
Exclusion
- Known condition of not functioning ovaries
- Known advanced endometriosis (stage III/IV)
- Considered unsuitable for controlled ovarian stimulation with a dosing regimen corresponding to approximately 225 IU/day gonadotropin, as judged by the investigator
- History of previous episode of OHSS or exuberant ovarian response to gonadotropins, and polycystic ovarian syndrome
- Any known hormonal or metabolic abnormalities which can compromise participation in the trial
- Known tumors of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus
Key Trial Info
Start Date :
July 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 16 2024
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT05263388
Start Date
July 15 2022
End Date
April 16 2024
Last Update
April 2 2025
Active Locations (16)
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1
Ferring Investigational Site
Wals-Seizenheim, Salzburg, Austria
2
Ferring Investigational Site
Vienna, Austria
3
Ferring Investigational Site
Montpellier, France
4
Ferring Investigational Site
Paris, France