Phase 3
N=300
A Trial to Compare the Ovarian Response of REKOVELLE and GONAL-F in Conventional Dosing in Women Undergoing Controlled Ovarian Stimulation
Infertility
Bottom Line
View on ClinicalTrials.gov: NCT05263388 ↗Enrolled (actual)
300
Serious AEs
0.7%
Results posted
Apr 2025
Primary outcome: Primary: Number of Oocytes Retrieved — 9.0; 9.0 Oocytes Retrieved
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- REKOVELLE (Follitropin Delta) (Drug); GONAL-F (Follitropin Alfa) (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Ferring Pharmaceuticals
- Primary completion
- Apr 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Oocytes Retrieved |
9.0; 9.0 | — |
| SECONDARY Number of Follicles (Total) at End-of-stimulation |
12.0; 12.0 | — |
| SECONDARY Size of the Follicles at End-of-stimulation |
15.7; 16.0 | — |
| SECONDARY Serum Concentrations of Estradiol at End-of-stimulation |
6085.0; 5853.5 | — |
| SECONDARY Serum Concentrations of Progesterone at End-of-stimulation |
2.9; 2.5 | — |
| SECONDARY Number of Fertilized Oocytes |
5.0; 5.0 | — |
| SECONDARY Fertilization Rate |
54.5; 57.7 | — |
| SECONDARY Number of Blastocysts and Number of Good Quality Blastocysts |
2.0; 3.0; 2.0; 2.0 | — |
| SECONDARY Total Gonadotropin Dose |
135; 148.5 | — |
| SECONDARY Number of Stimulation Days |
9.0; 9.0 | — |
| SECONDARY Proportion of Subjects With Early Ovarian Hyperstimulation Syndrome (OHSS) (Overall and by Grade) and/or Preventive Interventions for Early OHSS |
5; 3; 1; 1; 33; 17 | — |
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 of this trial is to see how many eggs are produced with a starting dose of 15 µg REKOVELLE compared to a starting dose of 225 IU GONAL-F. This research is intended to provide more knowledge about REKOVELLE, including the doses given in the trial.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT05263388). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.