Recombinant FSH Investigation in the Treatment of Infertility With Assisted Reproductive Technology (ART) (RITA-1)

NCT03740737 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 000001
• Study Type: interventional
• Target: 579
• Locations: 1 country
• Sites: 23

Brief Summary

This trial investigates the effects of FE 999049 compared to placebo.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Cumulative Ongoing Pregnancy Rate After the Fresh Cycle and Cryopreserved Cycles Initiated Within 12 Months From the Start of COS

  Defined as at least one intrauterine viable fetus 8-9 weeks after transfer. Data in this endpoint are presented for the fresh cycle and the cryopreserved cycles.

  8-9 weeks after transfer (up to approximately 16 months after start of stimulation)

Secondary Outcomes (68)

• Ongoing Pregnancy Rate in the Fresh Cycle and in the Cryopreserved Cycles

  8-9 weeks after transfer (up to approximately 16 months after start of stimulation)

• Time From Start of COS to Ongoing Pregnancy Across the Fresh and Cryopreserved Cycles

  8-9 weeks after transfer (up to approximately 16 months after start of stimulation)

• Time From Start of COS to Ongoing Pregnancy Across the Fresh and Cryopreserved Cycles, Measured in Number of Cycles Before Achieving Ongoing Pregnancy

  8-9 weeks after transfer (up to approximately 16 months after start of stimulation)

• Ongoing Implantation Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively

  8-9 weeks after transfer (up to approximately 16 months after start of stimulation)

• Clinical Pregnancy Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively

  5-6 weeks after transfer (up to approximately 15 months after start of stimulation)

Study Arms (2)

FE 999049 (Follitropin Delta)

EXPERIMENTAL

Drug: Follitropin delta

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Follitropin delta DRUG

FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 12 µg daily that was fixed for the first four stimulation days. Based on ovarian response, the dose could be adjusted by 3 µg, with dose increases implemented not more frequently than once every 2 days and dose decreases implemented per investigator's judgement. The minimum daily dose was 6 µg, and the maximum daily dose was 24 µg. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early ovarian hyperstimulation syndrome (OHSS) with the exception of gonadotropin-releasing hormone (GnRH) agonist for triggering of final follicular maturation, was not allowed.

Also known as: FE 999049, Rekovelle

FE 999049 (Follitropin Delta)

Placebo OTHER

Placebo was administered as single daily subcutaneous injection dialed to the same value (dose) as FE 999049. Participants could be treated for a maximum of 20 days. Coasting, use of dopamine agonist or any other drug to prevent early OHSS with the exception of GnRH agonist for triggering of final follicular maturation, was not allowed.

Placebo

Eligibility Criteria

• Age: 18 Years - 34 Years
• Gender Eligibility Details: Pre-menopausal females between the ages of 18 and 34 years at the time of randomization.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Informed Consent Documents signed prior to any trial-related procedure.
• In good physical and mental health in the judgement of the investigator.
• Pre-menopausal females between the ages of 18 and 34 years. The participants must be at least 18 years (including the 18th birthday) when they sign the informed consent and no more than 34 years (up to the day before the 35th birthday) at the time of randomization.
• Body mass index (BMI) between 17.5 and 38.0 kg/m2 (both inclusive) at screening.
• Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II or with partners diagnosed with male factor infertility, eligible for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm donor.
• Documented history of infertility for at least 12 months before randomization (not applicable in case of tubal or severe male factor infertility, or when the use of donor sperm is indicated).
• Regular menstrual cycles of 24-35 days (both inclusive).
• Hysterosalpingography, hysteroscopy or saline infusion sonography, documenting a uterus consistent with expected normal function (e.g. no evidence of clinically interfering uterine fibroids defined as submucous fibroids of any size or intramural fibroids larger than 3 cm in diameter, no polyps and no congenital structural abnormalities which are associated with a reduced chance of pregnancy) at screening or within 1 year prior to screening.
• Transvaginal ultrasound documenting presence and adequate visualization of both ovaries, without evidence of significant abnormality (e.g. enlarged ovaries which would contraindicate the use of gonadotropins) and normal adnexa (e.g. no hydrosalpinx) at screening. Both ovaries must be accessible for oocyte retrieval.
• Early follicular phase (cycle day 2-4) serum levels of FSH between 1 and 15 IU/L (results obtained within 3 months prior to randomization).
• Negative serum Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) antibody tests at screening or within 6 months prior to screening.
• Willing to accept single blastocyst transfer in the fresh cycle and in the cryopreserved cycles initiated within 12 months from the start of COS using blastocysts obtained in this trial.

You may not qualify if:

• More than one previous COS cycle for IVF/ICSI.
• Known endometriosis stage III-IV (defined by the revised ASRM classification, 2012 ).
• Known history of anovulation.
• One or more follicles greater than or equal to 10 mm (including cysts) observed on the transvaginal ultrasound prior to randomization on stimulation day 1.
• Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy \[excluding ectopic pregnancy\] and before week 24 of pregnancy).
• Known abnormal karyotype of participant or of her partner / sperm donor, as applicable, depending on source of sperm used for insemination in this trial. In case partner sperm will be used and the sperm production is severely impaired (concentration \<1 million/mL), normal karyotype, including no Y-chromosome microdeletion, must be documented.
• Any known clinically significant systemic disease (e.g. insulin-dependent diabetes).
• Known inherited or acquired thrombophilia.
• Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.
• Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) with the exception of pharmacologically controlled sub-clinical hypothyroidism.
• Known tumors of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus which would contraindicate the use of gonadotropins.
• Known moderate or severe impairment of renal or hepatic function.
• Any abnormal finding of clinical chemistry, hematology, thyroid-stimulating hormone (TSH) or prolactin, or vital signs at screening, which is judged clinically significant by the investigator.
• Known abnormal cervical cytology of clinical significance observed within three years prior to randomization (unless the clinical significance has been resolved).
• Findings at the gynecological examination at screening which preclude gonadotropin stimulation or are associated with a reduced chance of pregnancy, e.g. congenital uterine abnormalities or retained intrauterine device.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (23)

Fertility Treatment Center

Tempe, Arizona, 85284, United States

Location

HRC Fertility

Encino, California, 91436, United States

Location

Center for Advanced Reproductive Services PC

Farmington, Connecticut, 06032, United States

Location

Reproductive Associates of Delaware

Newark, Delaware, 19713, United States

Location

Women's Medical Research Group, LLC

Clearwater, Florida, 33759, United States

Location

Center for Reproductive Medicine

Winter Park, Florida, 32789, United States

Location

Fertility Institute of Hawaii, INC

Honolulu, Hawaii, 96814, United States

Location

Fertility Centers of Illinois (RH)

Chicago, Illinois, 60610, United States

Location

InVia Fertility

Hoffman Estates, Illinois, 60169, United States

Location

Boston IVF

Waltham, Massachusetts, 02451, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Reproductive Endocrinology Associates of Charlotte (REACH) S. Corporation

Charlotte, North Carolina, 28207, United States

Location

Carolina Conceptions

Raleigh, North Carolina, 27607, United States

Location

Institute for Reproductive Health

Cincinnati, Ohio, 45209, United States

Location

Abington Reproductive Medicine

Abington, Pennsylvania, 19046, United States

Location

Main Line Fertility Center

Bryn Mawr, Pennsylvania, 19010, United States

Location

Fertility Associates of Memphis, PLLC

Memphis, Tennessee, 38120, United States

Location

Center for Assisted Reproduction

Bedford, Texas, 76022, United States

Location

Houston Fertility Institute

Houston, Texas, 77063, United States

Location

Center of Reproductive Medicine

Webster, Texas, 77598, United States

Location

Utah Fertility Center

Pleasant Grove, Utah, 84062, United States

Location

Eastern Virginia Medical School | EVMS Obstetrics & Gynecology

Norfolk, Virginia, 23507, United States

Location

Seattle Reproductive Medicine WA

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• Scheiber MD, Doody KJ, Foster ED, Grover SA, Heiser PW; RITA-1 and RITA-2 (Recombinant FSH Investigation in the Treatment of Infertility with ART) trial groups. Ovarian stimulation with follitropin delta is safe and effective: results from the RITA randomized, double-blind, placebo-controlled trials. Fertil Steril. 2026 Jan;125(1):54-63. doi: 10.1016/j.fertnstert.2025.07.032. Epub 2025 Jul 24.

  PMID: 40714031 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

follitropin delta; FE 999049

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Results Point of Contact

• Title: Global Clinical Compliance
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

-

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: November 14, 2018
• Study Start: October 26, 2018
• Primary Completion: November 11, 2020
• Study Completion: November 11, 2020
• Last Updated: January 18, 2024
• Results First Posted: January 18, 2024

Record last verified: 2023-08

Locations

US (23)