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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)

ConditionInfertility
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-42
SponsorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Follitropin alfa/lutropin alfa (MBJ-0011)

    Combination product

    Follitropin alfa and lutropin alfa will be administered subcutaneously once daily with a starting dose of 150 International Unit (IU) of follitropin alfa, 75 IU of lutropin alfa, in ovarian stimulation up to 18 days.

  • hMG

    Drug

    Participants will receive 150 IU as solvent, subcutaneously, for solution for injection, daily (up to 18 days) during ovarian stimulation.

  • Cetrorelix acetate

    Drug

    Participants will receive 250 micrograms (mcg) of Cetrorelix acetate as Powder for reconstitution to a solution for injection with diluent in ampule, daily from Day 5 or 6 of stimulation up to the day of r-hCG.

  • Coriogonadotropin alfa

    Drug

    Participants will receive 250 mcg of r-hCG, as solution for injection, subcutaneously, during final follicular maturation.

  • Progesterone gel

    Drug

    Participants will self-administer progesterone gel 8 percent, with an applicator, at a dose of 90 milligram (mg), intravaginally, daily from oocyte retrieval during Luteal phase support.

Treatment groups

266 Participants
are divided into 2 treatment groups
Group A: Arm 1: Follitropin alfa/lutropin alfaExperimental treatment 4 interventions
Group B: Arm 2: Human Menopausal Gonadotropin (hMG)Active comparator 4 interventions

Trial outcomes

Primary outcomes

1

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

1

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)
2

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
3

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)
4

Serum Estradiol (E2) levels

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Merck KGaA, Darmstadt, Germany

Collaborator

Source ClinicalTrials.gov
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