A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)

Merck KGaA (EMD Serono)

Status and phase: Not yet enrolling; Phase 3

Conditions: Infertility

Treatments: Drug: Coriogonadotropin alfa; Drug: hMG; Drug: Cetrorelix acetate; Drug: Progesterone gel; Combination Product: Follitropin alfa/lutropin alfa (MBJ-0011)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07340827

MS132705_0007

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of follitropin alfa/lutropin alfa in Japanese participants with Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) deficiency undergoing Assisted reproductive technology (ART).

The study duration is approximately 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy in Part A.

Enrollment: 333 estimated patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who are premenopausal wishing to conceive
• Participants with maximum 1 previous stimulation for assisted reproductive technology (ART) without pregnancy
• Japanese Participants
• Participants are women with Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) deficiency congenital or acquired
• Participants have a vaginal ultrasound scan showing both ovaries and no clinically significant uterine abnormality and a normal antral follicle count (AFC) of at least 5 follicles 2 to 10 millimeter (mm) in diameter per ovary
• A semen analysis of the male partner been performed within 3 months prior to signature of informed consent and suitable for assisted reproductive technology
• Participants have a normal cervical ThinPrep® cytologic test, (TCT) or Pap smear within 12 months of Screening. If not available, a cervical smear will be performed as part of screening
• Other protocol defined criteria may apply

Exclusion criteria

• Participants with history of severe OHSS in any previous ovarian stimulation cycle
• Participants with Polycystic ovarian syndrome (PCOS) according to Rotterdam modified definition
• Participants with contraindication to treatment with gonadotropins, hypersensitivity to gonadotropins or to any of the excipients
• Participants with presence of known or suspected gonadotropin- or estrogen dependent malignancy (example. ovarian-, uterine-, or mammary carcinoma)
• Participants with ovarian enlargement or cyst of unknown etiology, or presence of an ovarian cyst greater than 25 millimeters before Day 1
• other protocol defined exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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333 participants in 2 patient groups

Arm 1: Follitropin alfa/lutropin alfa

Experimental group

Description:

Participants will receive fixed combination product of recombinant Follitropin alfa (rechFSH)/lutropin alfa (rechLH) in a 2:1 ratio.

Treatment:

Combination Product: Follitropin alfa/lutropin alfa (MBJ-0011)

Drug: Progesterone gel

Drug: Cetrorelix acetate

Drug: Coriogonadotropin alfa

Arm 2: Human Menopausal Gonadotropin (hMG)

Active Comparator group

Treatment:

Drug: Progesterone gel

Drug: Cetrorelix acetate

Drug: hMG

Drug: Coriogonadotropin alfa