Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 4 for:    CLARA Ferring
Previous Study | Return to List | Next Study

Comparison of MENOPUR Liquid and Powder in Women Undergoing ART (CLARA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04163458
Recruitment Status : Suspended (Temporary halt of recruitment due to COVID-19 pandemic)
First Posted : November 14, 2019
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals

Brief Summary:
Development of multiple follicles and pregnancy in ovulatory women undergoing controlled ovarian stimulation as part of an assisted reproductive technology (ART) cycle.

Condition or disease Intervention/treatment Phase
Infertility Drug: MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL Drug: MENOPUR powder and solvent for solution for injection, 75 IU Other: Placebo (for MENOPUR solution for injection in pre-filled pen) Other: Placebo (for MENOPUR powder and solvent for solution for injection) Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind Double-dummy Trial Comparing MENOPUR Solution for Injection in a Pre-filled Pen and MENOPUR Powder and Solvent for Solution for Injection (Menotropins for Injection) in a GnRH Agonist Cycle in Women Aged 18-42 Years Undergoing an Assisted Reproductive Technology Program
Actual Study Start Date : October 25, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Menotropins

Arm Intervention/treatment
Experimental: MENOPUR liquid
MENOPUR liquid (including placebo to MENOPUR powder) initiated at a fixed dose of 225 international units (IU) for first five stimulation days. From stimulation Day 6, dosing can be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose will be 450 IU/day and the minimum dose will be 75 IU/day. The dosing can continue for a maximum of 20 days.
Drug: MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL
Solution for injection in pre-filled pen, subcutaneous administration
Other Name: Highly purified menotropin

Other: Placebo (for MENOPUR powder and solvent for solution for injection)
Solution for injection in vials (powder and diluent); subcutaneous administration

Active Comparator: MENOPUR powder
MENOPUR powder (including placebo to MENOPUR liquid) initiated at a fixed dose of 225 IU for first five stimulation days. From stimulation Day 6, dosing can be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose will be 450 IU/day and the minimum dose will be 75 IU/day. The dosing can continue for a maximum of 20 days.
Drug: MENOPUR powder and solvent for solution for injection, 75 IU
Solution for injection in vials (powder and diluent), subcutaneous administration
Other Name: Highly purified menotropin

Other: Placebo (for MENOPUR solution for injection in pre-filled pen)
Solution for injection in pre-filled pen, subcutaneous administration




Primary Outcome Measures :
  1. Number of fertilized (2 pronuclei [2PN]) oocytes [ Time Frame: On Day 1 after oocyte retrieval (up to 23 days after start of stimulation) ]
    Fertilized oocytes with 2PN will be regarded as correctly fertilized.


Secondary Outcome Measures :
  1. Positive beta human chorionic gonadotropin (βhCG) rate [ Time Frame: 10-14 days after transfer (up to approximately 6 weeks after start of stimulation) ]
  2. Clinical pregnancy rate [ Time Frame: 5-6 weeks after transfer (up to approximately 10 weeks after start of stimulation) ]
    Clinical pregnancy will be based on detection of at least 1 intrauterine gestational sac with fetal heart beat on transvaginal ultrasound.

  3. Ongoing pregnancy rate [ Time Frame: 8-9 weeks after transfer (up to approximately 13 weeks after start of stimulation) ]
    Ongoing pregnancy will be based on detection of at least 1 intrauterine viable fetus by transvaginal or abdominal ultrasound

  4. Early pregnancy loss [ Time Frame: 8-9 weeks after transfer (up to approximately 13 weeks after start of stimulation) ]
    Number of participants with early pregnancy loss defined as a positive βhCG tests but no ongoing pregnancy.

  5. Follicular development on stimulation day 6 [ Time Frame: At stimulation Day 6 ]
    The total number of follicles and the number of follicles per size category will be reported.

  6. Follicular development on last day of stimulation [ Time Frame: At last day of stimulation (up to 20 stimulation days) ]
    The total number of follicles and the number of follicles per size category will be reported.

  7. Serum follicle-stimulating hormone (FSH) concentration [ Time Frame: At stimulation Day 1, 6, last day of stimulation (up to 20 stimulation days) and at oocyte retrieval (up to 22 days after start of stimulation) ]
  8. Serum Anti-Müllerian hormone (AMH) concentration [ Time Frame: At stimulation Day 1, last day of stimulation (up to 20 stimulation days) and at end-of-trial (up to approximately 6.5 months from the start of screening) ]
  9. Human chorionic gonadotropin concentration [ Time Frame: At stimulation Day 1, 6 and last day of stimulation (up to 20 stimulation days) ]
  10. Luteinizing hormone (LH) concentration [ Time Frame: At stimulation Day 1, 6 and last day of stimulation (up to 20 stimulation days) ]
  11. Progesterone (P4) concentration [ Time Frame: At stimulation Day 1, 6 and last day of stimulation (up to 20 stimulation days) ]
  12. Estradiol (E2) concentration [ Time Frame: At confirmation of down-regulation (up to <90 days before stimulation Day 1), stimulation Day 6 and last day of stimulation (up to 20 stimulation days) ]
  13. Number of oocytes retrieved [ Time Frame: On day of oocyte retrieval (up to 22 days after start of stimulation) ]
  14. Number of metaphase II oocytes [ Time Frame: On day of oocyte retrieval (up to 22 days after start of stimulation) ]
  15. Fertilization rate [ Time Frame: On Day 1 after oocyte retrieval (up to 23 days after start of stimulation) ]
    Fertilization rate is the number of 2PN oocytes divided by the number of oocytes retrieved.

  16. Number of blastocysts 5 days after oocyte retrieval [ Time Frame: On Day 5 after oocyte retrieval (up to 27 days after start of stimulation) ]
    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)

  17. Total gonadotropin dose [ Time Frame: Up to 20 stimulation days ]
  18. Number of stimulation days [ Time Frame: Up to 20 stimulation days ]
  19. Proportion of participants with ovarian hyperstimulation syndrome (OHSS) [ Time Frame: ≤9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation (late OHSS) ]
  20. Frequency and intensity of adverse events [ Time Frame: From the start of screening until the end-of-trial (up to approximately 6.5 months) ]
  21. Changes in circulating levels of clinical chemistry parameters compared to baseline [ Time Frame: From the start of screening until the end-of-trial (up to approximately 6.5 months) ]
  22. Changes in circulating levels of haematology parameters compared to baseline [ Time Frame: From the start of screening until the end-of-trial (up to approximately 6.5 months) ]
  23. 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 ]
  24. Proportion of participants with treatment-induced anti-MENOPUR antibodies [ Time Frame: Up to 28 days after end of the stimulation period ]
  25. Technical malfunctions of the administration pen [ Time Frame: Up to 20 stimulation days ]
    Number of administration pens with technical malfunctions



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consents, prior to any trial-related procedure.
  • Females between the ages of 18 and 42 years. The participants must be at least 18 years (including the 18th 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 who desire pregnancy.
  • Body mass index (BMI) between 17.5 and 38.0 kg/m^2 (both inclusive) at screening.
  • Regular menstrual cycles of 24 to 35 days, presumed to be ovulatory.
  • Documented history of infertility for at least 12 months before randomization for women ≤35 years or for at least 6 months for women ≥36 years. Women with documented bilateral tubal occlusion or male factor infertility requiring the use of donor sperm established as a cause of infertility are eligible at diagnosis.
  • Early follicular phase (cycle day 2-4) serum FSH level between 1 and 12 IU/L (results obtained within 3 months prior to randomization).
  • Male partner with semen analysis that is at least adequate for intracytoplasmic sperm injection (ICSI) at screening or within 6 months prior to the screening date. Partners with severe male factors requiring invasive or surgical sperm retrieval may not be used. Use of donor sperm is allowed.
  • At least 1 cycle with no fertility medication immediately prior to screening.
  • Hysterosalpingography, hysteroscopy, or saline hysterosonogram documenting uterine anatomy appropriate for ART at screening or within 12 months prior to screening.
  • Transvaginal ultrasound documenting presence and adequate visualization of both ovaries, without evidence of clinically significant abnormality (e.g., endometrioma ≥3 cm, no dermoid cysts) and normal adnexa (e.g., no hydrosalpinx) at screening. Both ovaries must be accessible for oocyte retrieval.

Exclusion Criteria:

  • More than two previous controlled ovarian stimulation cycles for in vitro fertilization (IVF)/ICSI
  • Known stage III-IV endometriosis (American Society for Reproductive Medicine, 2012).
  • Oocyte donor or embryo recipient; gestational or surrogate carrier.
  • Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy [excluding ectopic pregnancy] and before week 24 of pregnancy).
  • Participant's male partner, with obvious leukospermia (>2 million white blood cells/mL) or signs of infection in semen sample within 6 months of the participant's screening. If either of these conditions exists, the male should be treated with antibiotics and retested prior to the participant's randomization.
  • Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.
  • Any known endocrine (total testosterone, prolactin and TSH) or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) with the exception of controlled thyroid function disease.
  • Known tumors of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus which would contraindicate the use of gonadotrophins.
  • Any abnormal finding of clinical chemistry, hematology and vital signs at screening, which is judged clinically significant by the investigator.
  • Pregnancy (negative urine pregnancy test must be documented at screening and prior to the first investigational medicinal product [IMP] administration), or contraindication to pregnancy.
  • Hypersensitivity to any active ingredient or excipients in the medicinal products used in this trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04163458


Locations
Show Show 20 study locations
Sponsors and Collaborators
Ferring Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Global Clinical Compliance Ferring Pharmaceuticals

Layout table for additonal information
Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04163458    
Other Study ID Numbers: 000303
First Posted: November 14, 2019    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ferring Pharmaceuticals:
Controlled Ovarian Stimulation
Assisted Reproductive Technology
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Genital Diseases, Male
Genital Diseases, Female
Menotropins
Pharmaceutical Solutions
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs