Comparison of MENOPUR Liquid and Powder in Women Undergoing Assisted Reproductive Technology (ART) (CLARA)
Infertility
About this trial
This is an interventional treatment trial for Infertility focused on measuring Controlled Ovarian Stimulation, Assisted Reproductive Technology
Eligibility 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.
Sites / Locations
- Fertility Treatment Center
- Fertility Specialists Medical Group - San Diego Center for Reproductive Surgery
- Center for Advanced Reproductive Services PC
- Yale Fertility Center
- Fertility and IVF Center of Miami
- Center for Reproductive Medicine
- Idaho Center for Reproductive Medicine
- Fertility Centers of Illinois
- InVia Fertility Specialists, SC
- Fertility Answers, LLC
- SIRM Fertility Center
- Reproductive Endocrinology Associates of Charlotte
- Carolina Conceptions
- Institute for Reproductive Health
- OU Physicians Reproductive Medicine
- Abington Reproductive Medicine
- Fertility Associates of Memphis, PLLC
- Center for Assisted Reproduction
- Houston Fertility Institute
- Center of Reproductive Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
MENOPUR liquid
MENOPUR powder
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.
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.