A Phase 3 interventional study of Follitropin alfa/lutropin alfa (MBJ-0011) and hMG in Infertility, sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany. Recruiting at 21 sites in Japan. Open to female participants aged 18 Years to 42 Years. Per ClinicalTrials.gov, last updated 2026-10-29.
Sponsored by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (part of Merck KGaA, Darmstadt, Germany) · Phase 3, Interventional, and Treatment
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.
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's planned enrollment of 266 is above the median of 135 across 1,412 interventional studies indexed under Infertility.
Browse Infertility studies →Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany is the lead sponsor of 55 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive fixed combination product of recombinant Follitropin alfa (rechFSH)/lutropin alfa (rechLH) in a 2:1 ratio.
Combination Product: Follitropin alfa/lutropin alfa (MBJ-0011) · Drug: Cetrorelix acetate · Drug: Coriogonadotropin alfa · Drug: Progesterone gel
Drug: hMG · Drug: Cetrorelix acetate · Drug: Coriogonadotropin alfa · Drug: Progesterone gel
Drug pages: Follitropin alfa · Lutropin alfa
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.
Also known as: MBJ-0011, r-hFSH/r-hLH
Participants will receive 150 IU as solvent, subcutaneously, for solution for injection, daily (up to 18 days) during ovarian stimulation.
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.
Also known as: GnRH, antagonist
Participants will receive 250 mcg of r-hCG, as solution for injection, subcutaneously, during final follicular maturation.
Also known as: r-hCG
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.
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)
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
Time frame: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy
Number of Participants With Ovarian Hyperstimulation Syndrome (OHSS)
Time frame: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy
Number of Participants With Mild, Moderate, and Severe Ovarian Hyperstimulation Syndrome
Time frame: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy
Number of Cycles Cancelled due to Risk of Ovarian Hyperstimulation Syndrome
Time frame: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy
Number of Participants With Clinically Significant Changes in Laboratory Parameters and Vital Signs
Time frame: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy
Number of Participants Experiencing Local Reactions
Pain redness, swelling, bruising, and itching around the injection site will be assessed.
Time frame: 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy
Plan to share: Yes — IPD supporting publicly available results will be evaluated for sharing.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report, Analytic code
Time frame: IPD from completed trials will be publicly available within 6 months after all of the following events: Approval of a product/new indication by major authorities (FDA, EMA, PMDA if requested) with no pending submissions Public results via primary manuscript or trial registry disclosure Legal authority to share data Privacy protections are in place If approval is not sought or development is globally discontinued, data will be publicly available within 18 months after global trial completion. Further information on how to request data can be found on our website bit.ly/IPD21
Access criteria: Qualified researchers may propose access to IPD from sponsored trials via https://vivli.org/members/ourmembers/.
Data sharing details ↗ · vivli.org
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Follitropin alfa · Lutropin alfa
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany →