Comparison of MENOPUR Liquid and Powder in Women Undergoing Assisted Reproductive Technology (ART)
NCT ID: NCT04163458
Last Updated: 2023-11-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
405 participants
INTERVENTIONAL
2019-10-25
2021-07-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study Comparing MENOPUR in a Pen Formulation With a Powder and Solvent Formulation in Healthy Women
NCT04902131
Multicenter, Randomized, Open Label, Parallel Study to Evaluate the Efficacy & Safety of IVF-M HP Inj. vs. Menopur® Inj.
NCT02458768
MENOPUR® Versus FOLLISTIM®
NCT00802360
Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)
NCT00805935
MENOPUR in Gonadotrophin-releasing Hormone (GnRH) Antagonist Cycles With Single Embryo Transfer
NCT00884221
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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 could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.
MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL
Solution for injection in pre-filled pen, subcutaneous administration
Placebo (for MENOPUR powder and solvent for solution for injection)
Solution for injection in vials (powder and diluent); subcutaneous administration
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 could be adjusted as needed every second day by 75 IU per adjustment based on the participant's follicular response. The maximum dose was 450 IU/day and the minimum dose was 75 IU/day. The dosing could continue for a maximum of 20 days.
MENOPUR powder and solvent for solution for injection, 75 IU
Solution for injection in vials (powder and diluent), subcutaneous administration
Placebo (for MENOPUR solution for injection in pre-filled pen)
Solution for injection in pre-filled pen, subcutaneous administration
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL
Solution for injection in pre-filled pen, subcutaneous administration
MENOPUR powder and solvent for solution for injection, 75 IU
Solution for injection in vials (powder and diluent), subcutaneous administration
Placebo (for MENOPUR solution for injection in pre-filled pen)
Solution for injection in pre-filled pen, subcutaneous administration
Placebo (for MENOPUR powder and solvent for solution for injection)
Solution for injection in vials (powder and diluent); subcutaneous administration
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
42 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ferring Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Global Clinical Compliance
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fertility Treatment Center
Tempe, Arizona, United States
Fertility Specialists Medical Group - San Diego Center for Reproductive Surgery
San Diego, California, United States
Center for Advanced Reproductive Services PC
Farmington, Connecticut, United States
Yale Fertility Center
New Haven, Connecticut, United States
Fertility and IVF Center of Miami
Miami, Florida, United States
Center for Reproductive Medicine
Winter Park, Florida, United States
Idaho Center for Reproductive Medicine
Boise, Idaho, United States
Fertility Centers of Illinois
Chicago, Illinois, United States
InVia Fertility Specialists, SC
Hoffman Estates, Illinois, United States
Fertility Answers, LLC
Baton Rouge, Louisiana, United States
SIRM Fertility Center
Las Vegas, Nevada, United States
Reproductive Endocrinology Associates of Charlotte
Charlotte, North Carolina, United States
Carolina Conceptions
Raleigh, North Carolina, United States
Institute for Reproductive Health
Cincinnati, Ohio, United States
OU Physicians Reproductive Medicine
Oklahoma City, Oklahoma, United States
Abington Reproductive Medicine
Abington, Pennsylvania, United States
Fertility Associates of Memphis, PLLC
Memphis, Tennessee, United States
Center for Assisted Reproduction
Bedford, Texas, United States
Houston Fertility Institute
Houston, Texas, United States
Center of Reproductive Medicine
Webster, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
000303
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.