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

Ferring Pharmaceuticals302 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

302

Conditions

Infertility

Interventions

REKOVELLE (Follitropin Delta)DRUG

REKOVELLE administered as single daily subcutaneous injections in the abdomen. The starting dose of REKOVELLE was 15 μg fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the gonadotropin-releasing hormone (GnRH) antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily REKOVELLE dose could be increased or decreased by 5 μg based on the participant's response. The minimum REKOVELLE dose was 5 μg and the maximum REKOVELLE was 20 μg. Participants could be treated for a maximum of 20 days.

GONAL-F (Follitropin Alfa)OTHER

GONAL-F administered as single daily subcutaneous injections in the abdomen. The starting dose of GONAL-F was 225 IU fixed for the first four stimulation days. Dose adjustments could be implemented on the day of starting the GnRH antagonist (stimulation day 5 or day 6) or later, could occur no more frequently than every second day. At each dose adjustment, the daily GONAL-F dose could be adjusted by 75 IU based on the participant's response. The minimum GONAL-F dose was 75 IU and the maximum GONAL-F dose was 300 IU. Participants could be treated for a maximum of 20 days.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (16)

Ferring Investigational Site

Wals-Seizenheim, Salzburg, Austria

Ferring Investigational Site

Vienna, Austria

Ferring Investigational Site

Montpellier, France

Outcomes

Primary Outcomes

Number of Oocytes Retrieved

The number of oocytes retrieved was recorded at the oocyte retrieval visit.

Time frame: On day of oocyte retrieval (Up to 22 days after start of stimulation)

Secondary Outcomes

Number of Follicles (Total) at End-of-stimulation

Counted by transvaginal ultrasound for the right and left ovary for each subject.

Time frame: At end-of-stimulation (up to 20 stimulation days)

Size of the Follicles at End-of-stimulation

Counted by ultrasound for the right and left ovary for each subject.

Time frame: At end-of-stimulation (up to 20 stimulation days)

Serum Concentrations of Estradiol at End-of-stimulation

Blood samples for analysis of circulating concentrations of estradiol were drawn.

Time frame: At end-of-stimulation (up to 20 stimulation days)

Serum Concentrations of Progesterone at End-of-stimulation

Blood samples for analysis of circulating concentrations of progesterone were drawn.

Time frame: At end-of-stimulation (up to 20 stimulation days)

Number of Fertilized Oocytes

The number of pronuclei were counted after insemination. Fertilized oocytes with 2 pronuclei (2PN) were regarded as correctly fertilized.

Time frame: On day 1 after oocyte retrieval (up to 23 days after start of stimulation)

Fertilization Rate

The fertilization rate was defined as the number of oocytes with 2PN divided by the number of oocytes retrieved.

Data from ClinicalTrials.gov

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