Infertility
Conditions
Interventions
[Arm 1]
Arm Title: Follitropin alfa/lutropin alfa
Type: Experimental
Description: Participants will receive fixedcombination product of recombinantFollitropin alfa (rechFSH)/lutropinalfa (rechLH) in a
Sponsors
Ishii Kyoko
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: - Participants who are premenopausal wishing to conceive-Participants with maximum 1 previous stimulation for assistedreproductive technology (ART) without pregnancy - Japanese Participants - Participants are women with FSH and LH deficiency congenital oracquired - Participants have a vaginal ultrasound scan showing both ovariesand no clinically significant uterine abnormality and a normal antralfollicle count (AFC) of at least 5 follicles 2 to 10 millimeter (mm) indiameter per ovary - A semen analysis of the male partner been performed within3 months prior to signature of informed consent and suitablefor ART - Participants have a normal cervical ThinPrep cytologic test, (TCT) orPap smear within 12 monthsof Screening. If not available, a cervical smear will beperformed as part of screening - Other protocol defined criteria may apply
Exclusion criteria
Exclusion criteria: - Participants with history of severe OHSS in any previous ovarianstimulation cycle - Participants with Polycystic ovarian syndrome (PCOS) according toRotterdam 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-, ormammary carcinoma) - Participants with ovarian enlargement or cyst of unknown etiology,orpresence of an ovarian cyst greater than > 25 mm before Day 1 - other protocol defined exclusion criteria may apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome Measure: Total number of oocytes retrieved TimeFrame: At approximately 36 to 38 hours afterr-hCG administration (Day 4) Description: Mean number of oocytes retrievedwill be calculated. Oocyte retrievalwas a technique used in in-vitrofertilization in order to removeoocytes from the ovary of the female,enabling fertilization outside thebody. | — |
Contacts
Public ContactContact for Clinical Trial Information
Merck Biopharma Co., Ltd.
Outcome results
None listed