AzTrials
AzTrials

Infertility, FemalePhase 3RITA-2NCT03738618

Recombinant FSH Investigation in the Treatment of Infertility With Assisted Reproductive Technology (ART) (RITA-2)

A Phase 3 study testing Follitropin delta in people with Infertility, Female, run by Ferring Pharmaceuticals at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial investigates the effects of FE 999049 compared to placebo. Read more about this study

Who is it for?
Ages 35 to 42 years, women only
Conditions the study is for
Infertility, Female
What is being tested?
Follitropin delta
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
588 participants
Where
24 sitesUnited States
Study dates
29 Oct 2018to 21 Dec 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 42 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Informed Consent Documents signed prior to any trial-related procedure.
  • In good physical and mental health in the judgement of the investigator.
  • Pre-menopausal women between the ages of 35 and 42 years. The participants must be at least 35 years (including the 35th birthday) when they sign the informed consent and no more than 42 years (up to the day before the 42nd birthday) at the time of randomization.
  • Body mass index (BMI) between 17.5 and 38.0 kg/m^2 (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 6 months before randomization (not applicable in case of tubal or severe male factor infertility, or when the use of donor sperm is indicated).
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  • 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 the blastocyst transfer policy for the fresh cycle and the cryopreserved cycles initiated within 12 months from the start of controlled ovarian stimulation using blastocysts obtained in this trial, i.e. transfer of one blastocyst (if a good-quality blastocyst is available) or transfer of one or two blastocysts (if no good-quality blastocyst is available).

Who cannot join

  • More than one previous controlled ovarian stimulation 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 less than 1 million/mL), normal karyotype, including no Y-chromosome microdeletion, must be documented.
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  • 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.
  • Pregnancy (negative urinary pregnancy tests must be documented at screening and prior to randomization) or contraindication to pregnancy.
  • Known current active pelvic inflammatory disease.
  • Use of fertility modifiers during the last menstrual cycle before randomization, including dehydroepiandrosterone (DHEA), metformin or cycle programming with oral contraceptives, progestogen or estrogen preparations.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

United States24 sites

  • Abington Reproductive Medicine

    Abington, Pennsylvania, 19046

  • Center for Assisted Reproduction

    Bedford, Texas, 76022

  • Main Line Fertility Center

    Bryn Mawr, Pennsylvania, 19010

  • Reproductive Endocrinology Associates of Charlotte (REACH) S. Corporation

    Charlotte, North Carolina, 28207

  • Fertility Centers of Illinois (RH)

    Chicago, Illinois, 60610

  • Institute for Reproductive Health

    Cincinnati, Ohio, 45209

  • Women's Medical Research Group, LLC

    Clearwater, Florida, 33759

  • HRC Fertility

    Encino, California, 91436

  • Center for Advanced Reproductive Services PC

    Farmington, Connecticut, 06032

  • InVia Fertility

    Hoffman Estates, Illinois, 60169

  • Fertility Institute of Hawaii, INC

    Honolulu, Hawaii, 96814

  • Houston Fertility Institute

    Houston, Texas, 77063

  • Fertility Associates of Memphis, PLLC

    Memphis, Tennessee, 38120

  • Columbia University Fertility Center

    New York, New York, 10019

  • Reproductive Associates of Delaware

    Newark, Delaware, 19713

  • Eastern Virginia Medical School | EVMS Obstetrics & Gynecology

    Norfolk, Virginia, 23507

  • Utah Fertility Center

    Pleasant Grove, Utah, 84062

  • Carolina Conceptions

    Raleigh, North Carolina, 27607

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Seattle Reproductive Medicine WA

    Seattle, Washington, 98109

  • Fertility Treatment Center

    Tempe, Arizona, 85284

  • Boston IVF

    Waltham, Massachusetts, 02451

  • Center of Reproductive Medicine

    Webster, Texas, 77598

  • Center for Reproductive Medicine

    Winter Park, Florida, 32789

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Groups, Multicenter Trial Investigating the Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Women Aged 35-42 Years Undergoing Assisted Reproductive Technology

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

Being tested
Follitropin delta, Placebo
Medical subject headings
Infertility, Female

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Follitropin deltaDrug

    Also called FE 999049, REKOVELLE

    FE 999049 was administered as single daily subcutaneous injections in the abdomen at a starting dose of 15 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

  • PlaceboDrug

    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.

Study groups in NCT03738618
Study groupRoleWhat they receive
FE 999049 (Follitropin Delta)ExperimentalNot described
Receives: Drug: Follitropin delta
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cumulative Ongoing Pregnancy Rate After the Fresh Cycle and Cryopreserved Cycles Initiated Within 12 Months From the Start of Controlled Ovarian Stimulation (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.

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

Secondary outcomes (68)

  1. Ongoing Pregnancy Rate in the Fresh Cycle and in the Cryopreserved Cycles

    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.

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

  2. Time From Start of COS to Ongoing Pregnancy Across the Fresh and Cryopreserved Cycles, Including Duration

    Time from start of COS to ongoing pregnancy, including both the fresh and cryopreserved cycles.

    In the placebo group, no participants achieved an ongoing pregnancy either after 12 calendar months or after 12 study months.

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

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

    Time from start of COS to ongoing pregnancy, including both the fresh and cryopreserved cycles, measured in number of cycles before achieving ongoing pregnancy.

    In the placebo group, no participants achieved an ongoing pregnancy either after 12 calendar months or after 12 study months.

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

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

    Defined as the number of intrauterine viable fetuses 8-9 weeks after transfer divided by number of blastocysts transferred. Data in this endpoint are presented for the fresh cycle, the cryopreserved cycles, and all cycles.

    One participant can contribute with a range from zero to multiple blastocysts.

    Data is not shown for placebo arm because no subjects underwent blastocyst transfer in the fresh cycle or cryopreserved cycles.

    '%' in the unit of measure refers to 'percentage'.

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

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

    Defined at least one gestational sac 5-6 weeks after transfer. Data in this endpoint are presented for the fresh cycle, the cryopreserved cycles, and all cycles.

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

  6. Vital Pregnancy Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively

    Defined at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer. Data in this endpoint are presented for the fresh cycle, the cryopreserved cycles, and all cycles.

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

  7. Implantation Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively

    Defined as the number of gestational sacs 5-6 weeks after transfer divided by number of blastocysts transferred. The endpoint are presented for the fresh cycle, the cryopreserved cycles, and all cycles.

    One participant can contribute with a range from zero to multiple blastocysts.

    Data is not shown for placebo arm because no subjects underwent blastocyst transfer in the fresh cycle or cryopreserved cycles.

    '%' in the unit of measure refers to 'percentage'.

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

  8. Positive Beta Human Chorionic Gonadotropin (βhCG) Rate in the Fresh Cycle, the Cryopreserved Cycles and Cumulatively

    Defined as positive serum βhCG test 10-14 days after transfer. Data in this endpoint are presented for the fresh cycle, the cryopreserved cycles, and all cycles.

    Measured: 10-14 days after transfer (up to approximately 14 months after start of stimulation)

  9. Proportion of Subjects in the Fresh Cycle With Triggering of Final Follicular Maturation (With hCG, With GnRH Agonist, and in Total), Cycle Cancellation and Transfer Cancellation

    Data in this endpoint are presented for the fresh cycle.

    Measured: Up to 5 days after oocyte retrieval (up to 27 days after start of stimulation)

  10. Number of Follicles on Stimulation Day 5

    The total number of follicles and the number of follicles per size category are reported.

    Measured: On stimulation day 5

  11. Number of Follicles at End-of-stimulation

    The total number of follicles and the number of follicles per size category are reported.

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

  12. Size of Follicles on Stimulation Day 5

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

    Measured: On stimulation day 5

  13. Size of Follicles at End-of-stimulation

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

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

  14. Number of Oocytes Retrieved

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

    Measured: On day of oocyte retrieval (up to 22 days after start of stimulation)

  15. Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved

    Grouped according to the number of oocytes retrieved. Participants with cycle cancellation due to poor ovarian response are included in the <4 oocytes group.

    Measured: On day of oocyte retrieval (up to 22 days after start of stimulation)

  16. Number of Metaphase II Oocytes

    The number of MII oocytes to oocytes retrieved for participants where all oocytes were inseminated using ICSI are presented.

    Measured: On day of oocyte retrieval (up to 22 days after start of stimulation)

  17. Number of Fertilized Oocytes

    An oocyte was defined as fertilized if it had 2 pronuclei (2PN) at 19h (±2h).

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

  18. Fertilization Rate

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

    Fertilization rate relative to oocytes retrieved has been reported.

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

  19. Number and Quality of Blastocysts on Day 5 After Oocyte Retrieval

    Number of blastocysts (total and good-quality) on Day 5 are 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.

    Measured: On day 5 after oocyte retrieval

  20. Endometrial Thickness on Stimulation Day 5

    Mean endometrial thickness is reported.

    Measured: On stimulation day 5

  21. Endometrial Thickness at End-of-stimulation

    Mean endometrial thickness is reported.

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

  22. Echogenicity Pattern on Stimulation Day 5

    The distribution of participants with hypoechogenic, isoechogenic, or hyperechogenic endometrium is reported

    Measured: On stimulation day 5

  23. Echogenicity Pattern at End-of-stimulation

    The distribution of participants with hypoechogenic, isoechogenic, or hyperechogenic endometrium is reported.

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

  24. Oocyte Utilization Rate

    Defined as the number of blastocysts transferred or cryopreserved divided by the number of oocytes retrieved.

    Data in this endpoint are presented for the cryopreserved cycles.

    Measured: On day of oocyte retrieval up to 12 months after start of COS

  25. Oocyte Efficiency Index

    Defined as the cumulative number of ongoing pregnancies per oocyte retrieved.

    Data in this endpoint are presented for the cryopreserved cycles.

    The unit of measure for this endpoint is 'cumulative ongoing pregnancies/oocyte retrieved'.

    Measured: 8-9 weeks after transfer

  26. Percentage of Blastocysts Surviving Cryopreservation

    Data in this endpoint are presented for the cryopreserved cycles.

    The unit is number of blastocysts with observations. One participant can contribute with a range from zero to multiple blastocysts.

    Measured: 0 hour (+0.5 hour) after thawing

  27. Percentage of Blastocysts With Re-expansion After Cryopreservation

    Data in this endpoint are presented for the cryopreserved cycles.

    The unit is number of blastocysts with observations. One participant can contribute with a range from zero to multiple blastocysts.

    Measured: 2.5 hour (±0.5 hour) after thawing

  28. Number of Cryopreserved Cycles Initiated Within 12 Months From the Start of COS

    The total number of cryopreserved cycles initiated are reported. Data in this endpoint are presented for the cryopreserved cycles.

    One participant can contribute with a range from zero to multiple blastocysts.

    Measured: Up to 12 months after start of stimulation

  29. Number of Cryopreserved Cycles With Blastocyst Transfer

    The total number of cryopreserved cycles with blastocyst transfer are reported. Data in this endpoint are presented for the cryopreserved cycles.

    One participant can contribute with a range from zero to multiple blastocysts.

    Measured: Up to 12 months after start of stimulation

  30. Circulating Concentrations of Anti-mullerian Hormone (AMH)

    Blood samples for analysis of circulating concentrations of AMH were drawn. The median and inter-quartile range (IQR) of AMH levels on stimulation day 1, stimulation day 5, end-of-stimulation visit and oocyte retrieval visit are presented.

    Measured: From screening to the day of oocyte retrieval (up to 22 days after start of stimulation)

  31. Circulating Concentrations of Follicle-stimulating Hormone (FSH)

    Blood samples for analysis of circulating concentrations of FSH were drawn. The median and IQR of FSH levels on stimulation day 1, stimulation day 5, end-of-stimulation visit and oocyte retrieval visit are presented.

    Measured: From screening to the day of oocyte retrieval (up to 22 days after start of stimulation)

  32. Circulating Concentrations of Luteinizing Hormone (LH)

    Blood samples for analysis of circulating concentrations of LH were drawn. The median and IQR of LH levels on stimulation day 1, stimulation day 5, end-of-stimulation visit and oocyte retrieval visit are presented.

    Measured: From screening to the day of oocyte retrieval (up to 22 days after start of stimulation)

  33. Circulating Concentrations of Estradiol

    Blood samples for analysis of circulating concentrations of estradiol were drawn. The median and IQR of estradiol levels on stimulation day 1, stimulation day 5, end-of-stimulation visit and oocyte retrieval visit are presented.

    Measured: From screening to the day of oocyte retrieval (up to 22 days after start of stimulation)

  34. Circulating Concentrations of Progesterone

    Blood samples for analysis of circulating concentrations of progesterone were drawn. The median and IQR of progesterone levels on stimulation day 1, stimulation day 5, end-of-stimulation visit and oocyte retrieval visit are presented.

    Measured: From screening to the day of oocyte retrieval (up to 22 days after start of stimulation)

  35. Circulating Concentrations of Inhibin A

    Blood samples for analysis of circulating concentrations of inhibin A were drawn. The median and IQR of inhibin A levels on stimulation day 1, stimulation day 5, end-of-stimulation visit and oocyte retrieval visit are presented.

    Measured: From screening to the day of oocyte retrieval (up to 22 days after start of stimulation)

  36. Circulating Concentrations of Inhibin B

    Blood samples for analysis of circulating concentrations of inhibin B were drawn. The median and IQR of inhibin B levels on stimulation day 1, stimulation day 5, end-of-stimulation visit and oocyte retrieval visit are presented.

    Measured: From screening to the day of oocyte retrieval (up to 22 days after start of stimulation)

  37. Total Gonadotropin Dose

    Calculated by start dates, end dates and daily dose of IMP.

    Measured: Up to 20 stimulation days

  38. Number of Stimulation Days

    Calculated by start dates and end dates.

    Measured: Up to 20 stimulation days

  39. Proportion of Participants With Investigator-requested Gonadotropin Dose Adjustments

    Investigator-requested decreases and increases of the gonadotropin dose.

    Measured: Stimulation Day 5

  40. Percentage of Participants With Adverse Events (AEs)

    Any AE occurring after start of IMP and before the end-of-trial visit, or a pre-treatment AE or pre-existing medical condition that worsens in intensity after start of IMP and before the end-of-trial visit was considered treatment-emergent, and is presented for this endpoint.

    Data in this endpoint are presented for the fresh cycle.

    Measured: From time of signing informed consent until the end-of-cycle visit in the fresh cycle (approximately 6 months)

  41. Intensity of AEs

    The intensity of AE was classified using the following 3-point scale: mild = awareness of signs or symptoms, but no disruption of usual activity; moderate = event sufficient to affect usual activity (disturbing); or severe = inability to work or perform usual activities (unacceptable).

    Data in this endpoint are presented for the fresh cycle.

    Measured: From time of signing informed consent until the end-of-cycle visit in the fresh cycle (up to approximately 6 months)

  42. Changes in Circulating Levels of Clinical Chemistry Compared to Baseline: Albumin, Protein

    Blood samples were collected for the analysis of clinical chemistry parameters including: Albumin and protein.

    Data in this endpoint are presented for the fresh cycle.

    Measured: From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months)

  43. Changes in Circulating Levels of Clinical Chemistry Compared to Baseline: Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase and Gamma Glutamyl Transferase

    Blood samples were collected for the analysis of clinical chemistry parameters including: Alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase and gamma glutamyl transferase.

    Data in this endpoint are presented for the fresh cycle.

    Measured: From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months)

  44. Changes in Circulating Levels of Clinical Chemistry Compared to Baseline: Bicarbonate, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Glucose, Phosphate, Potassium and Sodium

    Blood samples were collected for the analysis of clinical chemistry parameters including: Bicarbonate, blood urea nitrogen, calcium, chloride, cholesterol, glucose, Phosphate, Potassium and Sodium.

    Data in this endpoint are presented for the fresh cycle.

    Measured: From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months)

  45. Changes in Circulating Levels of Clinical Chemistry Compared to Baseline: Direct Bilirubin, Total Bilirubin, Creatinine, Urate

    Blood samples were collected for the analysis of clinical chemistry parameters including: Direct bilirubin, total bilirubin, creatinine, urate.

    Data in this endpoint are presented for the fresh cycle.

    Measured: From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months)

  46. Changes in Circulating Levels of Clinical Chemistry Compared to Baseline: Lactate Dehydrogenase

    Blood samples were collected for the analysis of clinical chemistry parameters including: Lactate dehydrogenase.

    Data in this endpoint are presented for the fresh cycle.

    Measured: From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months)

  47. Changes in Haematology Parameters Compared to Baseline: Erythrocytes

    Blood samples were collected for the analysis of haematology parameter including: Erythrocytes.

    Data in this endpoint are presented for the fresh cycle.

    Measured: From screening to the end-of-cycle visit in the fresh cycle (approximately 6 months)

  48. Changes in Haematology Parameters Compared to Baseline: Haemoglobin

    Blood samples were collected for the analysis of haematology parameters including: Haemoglobin.

    Data in this endpoint are presented for the fresh cycle.

    Measured: From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months)

  49. Changes in Haematology Parameters Compared to Baseline: Haematocrit

    Blood samples were collected for the analysis of haematology parameter including: Haematocrit.

    Data in this endpoint are presented for the fresh cycle.

    Measured: From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months)

  50. Changes in Haematology Parameters Compared to Baseline: Erythrocyte Mean Corpuscular Volume

    Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular volume.

    Data in this endpoint are presented for the fresh cycle.

    Measured: From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months)

  51. Changes in Haematology Parameters Compared to Baseline: Leukocytes and Platelets

    Blood samples were collected for the analysis of haematology parameters including: Leukocytes and platelets.

    Data in this endpoint are presented for the fresh cycle.

    Measured: From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months)

  52. Changes in Haematology Parameters Compared to Baseline: Erythrocyte Mean Corpuscular Hemoglobin

    Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular haemoglobin.

    Data in this endpoint are presented for the fresh cycle.

    Measured: From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months)

  53. Changes in Haematology Parameters Compared to Baseline: Erythrocyte Mean Corpuscular Haemoglobin Concentration

    Blood samples were collected for the analysis of haematology parameter including: Erythrocyte mean corpuscular haemoglobin concentration.

    Data in this endpoint are presented for the fresh cycle.

    Measured: From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months)

  54. Changes in Haematology Parameters Compared to Baseline: Basophils/Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Monocytes/Leukocytes and Neutrophils/Leukocytes

    Blood samples were collected for the analysis of haematology parameters including: Basophils/leukocytes, eosinophils/ leukocytes, lymphocytes/leukocytes, monocytes/leukocytes and neutrophils/leukocytes.

    Data in this endpoint are presented for the fresh cycle.

    Measured: From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months)

  55. Proportion of Subjects With Markedly Abnormal Changes of Clinical Chemistry Parameters: Alanine Aminotransferase, Aspartate Aminotransferase, Bicarbonate, Calcium, Potassium

    The table represents the percentage of participants in each group with normal baseline values and markedly abnormal end-of-stimulation or end-of-cycle visit values for alanine aminotransferase, aspartate aminotransferase, bicarbonate, calcium, potassium.

    Data in this endpoint are presented for the fresh cycle.

    Measured: From screening (baseline) to the end-of-cycle visit in the fresh cycle (approximately 6 months)

  56. Proportion of Subjects With Markedly Abnormal Changes of Haematology Parameters: Leukocytes, Eosinophils/Leukocytes, Lymphocytes/Leukocytes, Neutrophils/Leukocytes

    The table represents the percentage of participants in each group with normal baseline values and markedly abnormal end-of-stimulation or end-of-cycle visit values for Leukocytes, eosinophils/leukocytes, lymphocytes/leukocytes and neutrophils/leukocytes.

    Data in this endpoint are presented for the fresh cycle.

    Measured: From screening (baseline) to the end-of-stimulation visit and end-of-cycle visit in the fresh cycle (approximately 6 months)

  57. Frequency and Intensity of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Subject During the Stimulation Period

    Assessed by the participant during the stimulation period. Participants assessed the injection site reactions (redness, pain, itching, swelling and bruising) three times daily: immediately after the injection, 30 minutes after the injection and 24 hours after the injection.

    Measured: End-of-stimulation (up to 20 stimulation days)

  58. Intensity of Injection Site Reactions (Redness, Pain, Itching, Swelling and Bruising) Assessed by the Subject During the Stimulation Period

    Assessed by the participant during the stimulation period as mild, moderate or severe.

    Measured: End-of-stimulation (up to 20 stimulation days)

  59. Proportion of Subjects With Treatment-induced Anti-FSH Antibodies, Overall as Well as With Neutralizing Capacity

    Measured by presence of anti-FSH antibodies.

    95% Clopper-Pearson confidence interval has been reported in this endpoint.

    Measured: Up to 28 days after end of the stimulation period

  60. Frequency and Intensity of Immune-related Adverse Events

    Standardised Medical Dictionary for Regulatory Activities (MedDRA) Queries (SMQs).

    Measured: From time of signing informed consent for participation in the trial until the end-of-cycle visit in the fresh cycle (approximately 6 months)

  61. Proportion of Subjects With Cycle Cancellations Due to an Adverse Event, Including Immune-related Adverse Events, or Due to Technical Malfunctions of the Administration Pen

    For each participant the reason for cycle cancellation will be recorded.

    Data in this endpoint are presented for the fresh cycle.

    Measured: Up to 20 stimulation days

  62. Proportion of Subjects With OHSS, Overall and by Grade, and Proportion of Subjects With Moderate/Severe OHSS

    Classification of grade was according to Golan's classification system, and all OHSS cases were graded as mild, moderate or severe.

    Data in this endpoint are presented for the fresh cycle.

    Measured: ≤9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation until 21-28 days after last IMP dose or up to ongoing pregnancy 8-9 weeks after transfer in pregnant participants (late OHSS)

  63. Proportion of Subjects Hospitalized Due to OHSS and Proportion of Subjects Undergoing Paracentesis Due to OHSS

    Percentage of participants hospitalized or undergoing paracentesis due to OHSS are reported

    Measured: ≤9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation until 21-28 days after last IMP dose or up to ongoing pregnancy 8-9 weeks after transfer in pregnant participants (late OHSS)

  64. Proportion of Participants With Multi-fetal Gestation in the Fresh Cycle

    Defined as pregnancy with more than one fetus. Among participants with ongoing pregnancy, percentage of participants with twin pregnancies are presented.

    '%' in the unit of measure refers to 'percentage'.

    Measured: Up to 8-9 weeks after transfer

  65. Proportion of Cryopreserved Cycles With Multi-fetal Gestation

    Defined as pregnancy with more than one fetus. Among cryopreserved cycles with ongoing pregnancy, percentage of cycles with twin pregnancies are presented.

    '%' in the unit of measure refers to 'percentage'.

    Measured: Up to 8-9 weeks after transfer

  66. Biochemical Pregnancy, Spontaneous Abortion, Ectopic Pregnancy (With and Without Medical/Surgical Intervention) and Vanishing Twins in the Fresh Cycle

    The percentage of participants with biochemical pregnancy, spontaneous abortion, ectopic pregnancy (with and without medical/surgical intervention) and vanishing twins in the fresh cycle are presented.

    Data represents participants with positive βhCG.

    Data is not shown for placebo arm because no participants had a positive βhCG.

    '%' in the unit of measure refers to 'percentage'.

    Unit: % of participants with early pregnancy loss.

    Measured: Up to 8-9 weeks after transfer

  67. Biochemical Pregnancy, Spontaneous Abortion, Ectopic Pregnancy (With and Without Medical/Surgical Intervention) and Vanishing Twins in the Cryopreserved Cycles

    The percentage of cryopreserved cycles with biochemical pregnancy, spontaneous abortion, ectopic pregnancy (with and without medical/surgical intervention) and vanishing twins are presented.

    Data is not shown for placebo arm because no participants had a positive βhCG.

    '%' in the unit of measure refers to 'percentage'.

    Measured: Up to 8-9 weeks after transfer

  68. Proportion of Participants With Technical Malfunctions of the Administration Pen

    Incidences of technical malfunctions of the administration pen were recorded.

    Measured: Up to 20 stimulation days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2018
  2. Study start29 Oct 2018
  3. Primary completion21 Dec 2020
  4. Study completion21 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
588 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03738618
Sponsor's protocol ID
000002
Acronym
RITA-2
Status last verified
Aug 2023
First submitted
24 Oct 2018
Last updated
18 Jan 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 40714031

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Follitropin delta in people with Infertility, Female, run by Ferring Pharmaceuticals at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative Ongoing Pregnancy Rate After the Fresh Cycle and Cryopreserved Cycles Initiated Within 12 Months From the Start of Controlled Ovarian Stimulation (COS) (time frame: 8-9 weeks after transfer (up to approximately 16 months after start of stimulation)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03738618, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.

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