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

NCT04163458 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 000303
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 20

Brief Summary

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

Conditions

Infertility

Keywords

Controlled Ovarian Stimulation; Assisted Reproductive Technology

Outcome Measures

Primary Outcomes (1)

• Number of Fertilized (2 Pronuclei [2PN]) Oocytes

  Fertilized oocytes with 2PN were regarded as correctly fertilized.

  On Day 1 after oocyte retrieval (up to 23 days after start of stimulation)

Secondary Outcomes (53)

• Positive Beta Human Chorionic Gonadotropin (βhCG) Rate

  10-14 days after blastocyst transfer (up to approximately 6 weeks after start of stimulation)

• Clinical Pregnancy Rate

  5-6 weeks after blastocyst transfer (up to approximately 10 weeks after start of stimulation)

• Ongoing Pregnancy Rate

  8-9 weeks after blastocyst transfer (up to approximately 13 weeks after start of stimulation)

• Early Pregnancy Loss

  8-9 weeks after blastocyst transfer (up to approximately 13 weeks after start of stimulation)

• Follicular Development on Stimulation Day 6

  At stimulation Day 6

Study Arms (2)

MENOPUR liquid

EXPERIMENTAL

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.

Drug: MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL; Other: Placebo (for MENOPUR powder and solvent for solution for injection)

MENOPUR powder

ACTIVE COMPARATOR

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.

Drug: MENOPUR powder and solvent for solution for injection, 75 IU; Other: Placebo (for MENOPUR solution for injection in pre-filled pen)

Interventions

MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL DRUG

Solution for injection in pre-filled pen, subcutaneous administration

Also known as: Highly purified menotropin

MENOPUR liquid

MENOPUR powder and solvent for solution for injection, 75 IU DRUG

Solution for injection in vials (powder and diluent), subcutaneous administration

Also known as: Highly purified menotropin

MENOPUR powder

Placebo (for MENOPUR solution for injection in pre-filled pen) OTHER

Solution for injection in pre-filled pen, subcutaneous administration

MENOPUR powder

Placebo (for MENOPUR powder and solvent for solution for injection) OTHER

Solution for injection in vials (powder and diluent); subcutaneous administration

MENOPUR liquid

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (20)

Fertility Treatment Center

Tempe, Arizona, 85284, United States

Location

Fertility Specialists Medical Group - San Diego Center for Reproductive Surgery

San Diego, California, 92123, United States

Location

Center for Advanced Reproductive Services PC

Farmington, Connecticut, 06032, United States

Location

Yale Fertility Center

New Haven, Connecticut, 06511, United States

Location

Fertility and IVF Center of Miami

Miami, Florida, 33176, United States

Location

Center for Reproductive Medicine

Winter Park, Florida, 32789, United States

Location

Idaho Center for Reproductive Medicine

Boise, Idaho, 83702, United States

Location

Fertility Centers of Illinois

Chicago, Illinois, 60610, United States

Location

InVia Fertility Specialists, SC

Hoffman Estates, Illinois, 60169, United States

Location

Fertility Answers, LLC

Baton Rouge, Louisiana, 70817, United States

Location

SIRM Fertility Center

Las Vegas, Nevada, 89118, United States

Location

Reproductive Endocrinology Associates of Charlotte

Charlotte, North Carolina, 28207, United States

Location

Carolina Conceptions

Raleigh, North Carolina, 27607, United States

Location

Institute for Reproductive Health

Cincinnati, Ohio, 45209, United States

Location

OU Physicians Reproductive Medicine

Oklahoma City, Oklahoma, 73104, United States

Location

Abington Reproductive Medicine

Abington, Pennsylvania, 19046, United States

Location

Fertility Associates of Memphis, PLLC

Memphis, Tennessee, 38120, United States

Location

Center for Assisted Reproduction

Bedford, Texas, 76022, United States

Location

Houston Fertility Institute

Houston, Texas, 77063, United States

Location

Center of Reproductive Medicine

Webster, Texas, 77598, United States

Location

MeSH Terms

Conditions

Infertility

Interventions

Injections; Solvents; Solutions

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Specialty Uses of Chemicals; Chemical Actions and Uses; Pharmaceutical Preparations

Results Point of Contact

• Title: Global Clinical Compliance
• Organization: Ferring Pharmaceuticals

DK0-Disclosure@ferring.com

-

Study Officials

• Global Clinical Compliance

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: November 14, 2019
• Study Start: October 25, 2019
• Primary Completion: May 28, 2021
• Study Completion: July 16, 2021
• Last Updated: November 7, 2023
• Results First Posted: November 7, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)