A Trial to Compare the Ovarian Response of REKOVELLE and GONAL-F in Conventional Dosing in Women Undergoing Controlled Ovarian Stimulation (ADAPT-1)

Ferring

Status and phase

Completed

Phase 3

Conditions

Infertility

Treatments

Other: GONAL-F (Follitropin Alfa)

Drug: REKOVELLE (Follitropin Delta)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05263388

U1111-1267-1119 (Other Identifier)

000401

Details and patient eligibility

About

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.

Enrollment

302 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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