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Completed

NCT Number: NCT05263388

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

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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Ferring Investigational Site, Wals-Seizenheim, State of Salzburg, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of Oocytes Retrieved

    Time frame: 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 outcomes

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

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

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

  2. Size of the Follicles at End-of-stimulation

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

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

  3. Serum Concentrations of Estradiol at End-of-stimulation

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

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

  4. Serum Concentrations of Progesterone at End-of-stimulation

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

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

  5. Number of Fertilized Oocytes

    Time frame: 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.

  6. Fertilization Rate

    Time frame: 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.

  7. Number of Blastocysts and Number of Good Quality Blastocysts

    Time frame: 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.

  8. Total Gonadotropin Dose

    Time frame: Up to 20 stimulation days

    Calculated by start dates, end dates and daily dose of investigational medicinal product (IMP).

  9. Number of Stimulation Days

    Time frame: Up to 20 stimulation days

    Calculated by start dates and end dates.

  10. Proportion of Subjects With Early Ovarian Hyperstimulation Syndrome (OHSS) (Overall and by Grade) and/or Preventive Interventions for Early OHSS

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Official study title

A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre, Multinational Trial Comparing the Ovarian Response of a Starting Dose of 15 μg Follitropin Delta (REKOVELLE) to a Starting Dose of 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in Controlled Ovarian Stimulation in Women Undergoing an Assisted Reproductive Technology Programme

Acronym: ADAPT-1

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 2, 2022
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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