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)

Phase 3Not Yet RecruitingNCT07340827

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany333 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

333

Conditions

Infertility

Interventions

Follitropin alfa/lutropin alfa (MBJ-0011)COMBINATION_PRODUCT

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 42 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Total number of oocytes retrieved

Mean number of oocytes retrieved will be calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.

Time frame: At approximately 36 to 38 hours after r-hCG administration (Day 4)

Secondary Outcomes

Total dose of gonadotropin (IU) used

Total dose of Human Menopausal Gonadotropin (hMG) referred as IU of FSH.

Time frame: At Visit 3 after ovarian stimulation from Day 5 until Day of r-hCG (maximum 18 days)

Number of Days of Gonadotropin Treatment

Total number of days of ovarian stimulation will be reported.

Time frame: At Visit 3 after ovarian stimulation from Day 5-18

Total Number of Follicles Measuring greater than or equal to 14 millimeter (mm) and greater than or equal to 17 mm in diameter

Time frame: During Ovarian stimulation (Day 5 to Day 18)

Serum Estradiol (E2) levels

Time frame: At Visit 3 after ovarian stimulation from Day 5-18

Proportion of 2 Pronuclei Embryos/Fertilized Oocytes

The proportion of oocytes that fertilized after they were inseminated with the sperm will be reported.

Time frame: At 18 (Plus or minus two hours) hours after insemination

Number of blastocysts frozen

After the transfer of 1 fresh blastocysts - spare ones will be frozen.

Time frame: 5 days after insemination

Number of Participants With Clinical Pregnancy

A clinical pregnancy is a pregnancy that is confirmed by both pregnancy test (beta-hCG test) and sonographic confirmation of a gestational sac or with or without heartbeat (fetal sac).

Time frame: 35-42 days after Visit 5 (Blastocyst transfer)

Number of Participants With Ongoing Pregnancy

Ongoing pregnancy will be confirmed with transvaginal ultrasound (TVUS) showing heartbeat.

Time frame: up to 80 days after blastocyst transfer (pregnancy week 11 to 12)

Number of Participants With Treatment-Emergent Adverse Events and Treatment related Adverse Events