A Trial to Compare the Ovarian Response of REKOVELLE and GONAL-F in Conventional Dosing in Women Undergoing Controlled Ovarian Stimulation

Phase 3

Completed

Conditions: Infertility

Interventions: Drug: REKOVELLE (Follitropin Delta)
Other: GONAL-F (Follitropin Alfa)

Registration Number: NCT05263388

Lead Sponsor: Ferring Pharmaceuticals

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 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 302

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
REKOVELLE (Follitropin Delta)	REKOVELLE (Follitropin Delta)	-
GONAL-F (Follitropin Alfa)	GONAL-F (Follitropin Alfa)	-

Primary Outcome Measures

Name	Time	Method
Number of Oocytes Retrieved	On day of oocyte retrieval (Up to 22 days after start of stimulation)	The number of oocytes retrieved was recorded at the oocyte retrieval visit.

Secondary Outcome Measures

Name	Time	Method
Number of Follicles (Total) at End-of-stimulation	At end-of-stimulation (up to 20 stimulation days)	Counted by transvaginal ultrasound for the right and left ovary for each subject.
Size of the Follicles at End-of-stimulation	At end-of-stimulation (up to 20 stimulation days)	Counted by ultrasound for the right and left ovary for each subject.
Serum Concentrations of Estradiol at End-of-stimulation	At end-of-stimulation (up to 20 stimulation days)	Blood samples for analysis of circulating concentrations of estradiol were drawn.
Serum Concentrations of Progesterone at End-of-stimulation	At end-of-stimulation (up to 20 stimulation days)	Blood samples for analysis of circulating concentrations of progesterone were drawn.
Number of Fertilized Oocytes	On day 1 after oocyte retrieval (up to 23 days after start of stimulation)	The number of pronuclei were counted after insemination. Fertilized oocytes with 2 pronuclei (2PN) were regarded as correctly fertilized.
Fertilization Rate	On day 1 after oocyte retrieval (up to 23 days after start of stimulation)	The fertilization rate was defined as the number of oocytes with 2PN divided by the number of oocytes retrieved.
Number of Blastocysts and Number of Good Quality Blastocysts	On Day 5 or Day 6 (as applicable) after oocyte retrieval (up to 27 or 28 days after start of stimulation)	Number of blastocysts and number of good quality blastocysts on Day 5 or 6 were presented. The quality evaluation of blastocysts consisted of assessment of three parameters, as per the Gardner \& Schoolcraft system: blastocyst expansion and hatching status (graded: 1-6), inner cell mass (graded: A-D) and trophectoderm (graded: A-D). A good-quality blastocyst was defined as a blastocyst of grade 3BB or higher.
Total Gonadotropin Dose	Up to 20 stimulation days	Calculated by start dates, end dates and daily dose of investigational medicinal product (IMP).
Number of Stimulation Days	Up to 20 stimulation days	Calculated by start dates and end dates.
Proportion of Subjects With Early Ovarian Hyperstimulation Syndrome (OHSS) (Overall and by Grade) and/or Preventive Interventions for Early OHSS	Up to 9 days after triggering of final follicular maturation	Early OHSS is defined as OHSS with onset ≤9 days after triggering of final follicular maturation. Classification of grade was according to Golan's classification system, and all OHSS cases were graded as mild, moderate or severe.