Comparison of MENOPUR Liquid and Powder in Women Undergoing Assisted Reproductive Technology (ART)

Completed · Phase 3 · Has a placebo group

Conditions studied: Infertility

In brief

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

Key facts

Study ID

NCT04163458

Run by

Ferring Pharmaceuticals

People needed

405

Starts

2019-10-25

Expected to finish

2021-07-16

Last updated by the study team

2023-11-07

Who can join

Age: 18 and older, up to 42. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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