Infertility
Conditions
Keywords
Gonadotropins, infertility, prefilled pen
Brief summary
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.
Interventions
COMBINATION_PRODUCTFollitropin alfa/lutropin alfa (MBJ-0011)
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.
DRUGhMG
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.
DRUGCoriogonadotropin alfa
Participants will receive 250 mcg of r-hCG, as solution for injection, subcutaneously, during final follicular maturation.
DRUGProgesterone gel
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.
Sponsors
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total number of oocytes retrieved | At approximately 36 to 38 hours after r-hCG administration (Day 4) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total dose of gonadotropin (IU) used | At Visit 3 after ovarian stimulation from Day 5 until Day of r-hCG (maximum 18 days) | Total dose of Human Menopausal Gonadotropin (hMG) referred as IU of FSH. |
| Number of Days of Gonadotropin Treatment | At Visit 3 after ovarian stimulation from Day 5-18 | Total number of days of ovarian stimulation will be reported. |
| Total Number of Follicles Measuring greater than or equal to 14 millimeter (mm) and greater than or equal to 17 mm in diameter | During Ovarian stimulation (Day 5 to Day 18) | — |
| Serum Estradiol (E2) levels | At Visit 3 after ovarian stimulation from Day 5-18 | — |
| Proportion of 2 Pronuclei Embryos/Fertilized Oocytes | At 18 (Plus or minus two hours) hours after insemination | The proportion of oocytes that fertilized after they were inseminated with the sperm will be reported. |
| Number of blastocysts frozen | 5 days after insemination | After the transfer of 1 fresh blastocysts - spare ones will be frozen. |
| Number of Participants With Clinical Pregnancy | 35-42 days after Visit 5 (Blastocyst transfer) | 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). |
| Number of Participants With Ongoing Pregnancy | up to 80 days after blastocyst transfer (pregnancy week 11 to 12) | Ongoing pregnancy will be confirmed with transvaginal ultrasound (TVUS) showing heartbeat. |
| Number of Participants With Treatment-Emergent Adverse Events and Treatment related Adverse Events | 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy | — |
| Number of Participants With Ovarian Hyperstimulation Syndrome (OHSS) | 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 | 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 | 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 | 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy | — |
| Number of Participants Experiencing Local Reactions | 5.5 months for nonpregnant participants and 13 months for participants with confirmed pregnancy | Pain redness, swelling, bruising, and itching around the injection site will be assessed. |
Countries
Japan
Contacts
CONTACTCommunication Center
STUDY_DIRECTORMedical Responsible
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Outcome results
None listed