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Trial record 5 of 543 for:    RITA

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

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ClinicalTrials.gov Identifier: NCT03738618
Recruitment Status : Active, not recruiting
First Posted : November 12, 2018
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE October 24, 2018
First Posted Date  ICMJE November 12, 2018
Last Update Posted Date September 17, 2019
Actual Study Start Date  ICMJE October 29, 2018
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2018)
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 and approximately 16 months after start of stimulation) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03738618 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2018)
  • Ongoing pregnancy rate in the fresh cycle and in the cryopreserved cycles [ Time Frame: 8-9 weeks after transfer (up to approximately 16 months after start of stimulation) ]
  • Time from start of controlled ovarian stimulation (COS) to ongoing pregnancy across the fresh and cryopreserved cycles [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 5-6 weeks after transfer (up to approximately 15 months after start of stimulation) ]
  • Vital pregnancy rate in the fresh cycle, the cryopreserved cycles and cumulatively [ Time Frame: 5-6 weeks after transfer (up to approximately 15 months after start of stimulation) ]
  • Implantation rate in the fresh cycle, the cryopreserved cycles and cumulatively [ Time Frame: 5-6 weeks after transfer (up to approximately 15 months after start of stimulation) ]
  • Positive beta human chorionic gonadotropin (βhCG) rate in the fresh cycle, the cryopreserved cycles and cumulatively [ Time Frame: 10-14 days after transfer (up to approximately 14 months after start of stimulation) ]
  • Proportion of participants in the fresh cycle with triggering of final follicular maturation (with human chorionic gonadotropin [hCG], with gonadotropin releasing hormone [GnRH] agonist, and in total), cycle cancellation and transfer cancellation [ Time Frame: Up to 5 days after oocyte retrieval (up to 27 days after start of stimulation) ]
  • Number of follicles on stimulation day 5 [ Time Frame: On stimulation day 5 ]
    The total number of follicles and the number of follicles per size category will be reported
  • Number of follicles at end-of-stimulation [ Time Frame: At end-of-stimulation (up to 20 stimulation days) ]
    The total number of follicles and the number of follicles per size category will be reported
  • Number of oocytes retrieved [ Time Frame: On day of oocyte retrieval (up to 22 days after start of stimulation) ]
  • Proportion of participants with <4, 4-7, 8-14, 15-19 and ≥20 oocytes retrieved [ Time Frame: On day of oocyte retrieval (up to 22 days after start of stimulation) ]
  • Number of metaphase II oocytes [ Time Frame: On day of oocyte retrieval (up to 22 days after start of stimulation) ]
  • Number of fertilized oocytes and fertilization rate [ Time Frame: On day 1 after oocyte retrieval (up to 23 days after start of stimulation) ]
  • Number of blastocysts on Day 5 after oocyte retrieval [ Time Frame: On day 5 after oocyte retrieval ]
    The number of blastocysts (total and good-quality) will be reported. Blastocyst quality is assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring is based on the classification system by Gardner and Schoolcraft, with additional categories for inner cell mass (degenerative or no inner cell mass) and trophectoderm (degenerative or very large cells)
  • Endometrial thickness [ Time Frame: On stimulation day 5 and at end-of-stimulation (up to 20 stimulation days) ]
    Mean endometrial thickness will be reported
  • Echogenicity pattern [ Time Frame: On stimulation day 5 and at end-of-stimulation (up to 20 stimulation days) ]
    The distribution of subjects with hypoechogenic, isoechogenic, or hyperechogenic endometrium will be reported
  • Oocyte utilization rate [ Time Frame: On day of oocyte retrieval up to 12 months after start of controlled ovarian stimulation (COS) ]
  • Oocyte efficiency index [ Time Frame: 8-9 weeks after transfer ]
    The oocyte efficiency index will be calculated based on the number of oocytes retrieved and the cumulative number of ongoing pregnancies
  • Percentage of blastocysts surviving cryopreservation [ Time Frame: 0 hour (+0.5 hour) after thawing ]
  • Percentage of blastocysts with re-expansion after cryopreservation [ Time Frame: 2.5 hour (±0.5 hour) after thawing ]
  • Number of cryopreserved cycles initiated within 12 months from the start of controlled ovarian stimulation (COS), and number of cryopreserved cycles with blastocyst transfer [ Time Frame: Up to 12 months after start of stimulation ]
    The total number of cryopreserved cycles initiated and the number of cryopreserved cycles with blastocyst transfer will be reported
  • Circulating concentrations of anti-mullerian hormone (AMH), follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, progesterone, inhibin A and inhibin B [ Time Frame: From screening to the day of oocyte retrieval (up to 22 days after start of stimulation) ]
  • Total gonadotropin dose [ Time Frame: Up to 20 stimulation days ]
  • Number of stimulation days [ Time Frame: Up to 20 stimulation days ]
  • Number of dose adjustments [ Time Frame: Up to 20 stimulation days ]
  • Frequency and intensity of adverse events [ Time Frame: From time of signing informed consent until the end-of-cycle visit in the fresh cycle (approximately 6 months), and again in any cryopreserved cycle from cycle initiation until the end-of-cycle visit (approximately 3 months) ]
    From time of signing informed consent until the end-of-cycle visit in the fresh cycle (up to approximately 6 months)
  • Changes in circulating levels of clinical chemistry compared to baseline [ Time Frame: From screening to the end-of-cycle visit in the fresh cycle (approximately 6 months) ]
    Measured by CHEM-20
  • Changes in haematology parameters compared to baseline [ Time Frame: From screening to the end-of-cycle visit in the fresh cycle (approximately 6 months) ]
    Measured by complete blood count (CBC)
  • Frequency and intensity of injection site reactions (redness, pain, itching, swelling and bruising) assessed by the participant during the stimulation period [ Time Frame: Up to 20 stimulation days ]
  • Proportion of participants with treatment-induced anti-FSH antibodies [ Time Frame: Up to 28 days after end of the stimulation period ]
  • Frequency and intensity of immune-related adverse events [ Time Frame: From time of signing informed consent for participation in the trial until the end-of-cycle visit in the fresh cycle (approximately 6 months) ]
  • Proportion of participants with cycle cancellations due to an adverse event, including immune-related adverse events, or due to technical malfunctions of the administration pen [ Time Frame: Up to 20 stimulation days ]
  • Proportion of participants with ovarian hyperstimulation syndrome (OHSS), overall and by grade, and proportion of participants with moderate/severe OHSS [ Time Frame: ≤9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation (late OHSS) ]
  • Proportion of participants hospitalized due to ovarian hyperstimulation syndrome OHSS and proportion of participants undergoing paracentesis due to OHSS [ Time Frame: ≤9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation (late OHSS) ]
  • Rate of multi-fetal gestation, biochemical pregnancy, spontaneous abortion, ectopic pregnancy (with and without medical/surgical intervention) and vanishing twins in the fresh cycle and in the cryopreserved cycles [ Time Frame: Up to 8-9 weeks after transfer ]
    The percentage of subjects with each of these events will be reported
  • Technical malfunctions of the administration pen [ Time Frame: Up to 20 stimulation days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Recombinant FSH Investigation in the Treatment of Infertility With Assisted Reproductive Technology (ART) (RITA-2)
Official Title  ICMJE 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
Brief Summary This trial investigates the effects of FE 999049 compared to placebo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Infertility, Female
Intervention  ICMJE
  • Drug: Follitropin delta
    Follitropin delta
    Other Names:
    • FE 999049
    • Rekovelle
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Follitropin delta
    Intervention: Drug: Follitropin delta
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 25, 2019)
521
Original Estimated Enrollment  ICMJE
 (submitted: November 9, 2018)
550
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 subjects 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 43rd 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).
  • 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).

Exclusion Criteria:

  • 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 subject 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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Pre-menopausal women between the ages of 35 and 42 years at the time of randomization.
Ages  ICMJE 35 Years to 42 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03738618
Other Study ID Numbers  ICMJE 000002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ferring Pharmaceuticals
Study Sponsor  ICMJE Ferring Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Global Clinical Compliance Ferring Pharmaceuticals
PRS Account Ferring Pharmaceuticals
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP