Infertility Clinical Trial
Official title:
A Phase II, Multicenter, Randomized, Assessor-blinded, Active-comparator, Dose-finding Study to Evaluate AS900672 Enriched Versus Follitropin Alfa (Gonal-f®) in Stimulating Multiple Follicular Development in Infertile Women Undergoing Assisted Reproductive Technology (ART)
Verified date | January 2014 |
Source | Merck KGaA |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This is a Phase 2, interventional, prospective, multi-center, randomized, assessor-blind, active-comparator, dose-finding study to evaluate a new investigational long-acting follicle stimulating hormone (FSH) in infertile women who are undergoing an assisted reproductive technology (ART) procedure (In vitro fertilization/Intra cytoplasmic sperm injection [IVF/ICSI]). This study will compare 3 doses of the investigational drug versus a currently marketed drug follitropin alfa (Gonal-f® revised formulation female [RFF] Pen) in regards to the number of fertilized oocytes.
Status | Completed |
Enrollment | 520 |
Est. completion date | September 2008 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 36 Years |
Eligibility |
Inclusion Criteria : - Infertility and desire to conceive, justifying ART treatment - Age between 18 and 36 years, inclusive, at time of informed consent - Body mass index (BMI) 18 to 30 kilogram per square meter (kg/m^2), inclusive - Regular spontaneous menstrual cycles of 21 to 35 days - Presence of both ovaries - Transvaginal ultrasound within 6 weeks and hysterosalpingogram, hysterosonogram or hysteroscopy within 2 years prior to beginning OCP treatment, showing no clinically significant uterine abnormality, which, in the Investigator's opinion, could impair embryo implantation or pregnancy continuation - Normal early follicular phase (Day 2-4) serum FSH level, according to the local laboratory - Normal serum thyroid stimulating hormone (TSH) level, according to the local laboratory - Papanicolaou (PAP) smear test without clinically significant abnormalities within the last 6 months prior to beginning oral contraceptive therapy, - Negative pregnancy test prior to beginning GnRH-agonist therapy - Male partner with semen analysis which is at least adequate for ICSI within last 6 months prior to beginning GnRH agonist therapy, according to local laboratory - Willing and able to comply with the protocol - Voluntary provision of written informed consent, prior to any study-related procedure that was not part of normal medical care, with the understanding that the subject could withdraw consent at any time without prejudice to her future medical care, and - Willingness to provide follow-up information on babies born as part of this study - For subjects recruited at PK sub-study centers, voluntary provision of written informed consent to participate in the PK sub-study Exclusion Criteria: - Subject who require a starting dose of FSH greater than (>) 150 international unit per day (IU/day), in the opinion of the Investigator - Screening ultrasound demonstrating more than 12 follicles less than (<) 11 mm mean diameter in either ovary - Two or more previous ART cycles (consecutive or not) with poor response to gonadotrophin, defined as less than or equal to (=<)3 oocytes retrieved - Three or more previous consecutive ART cycles without a biochemical or clinical pregnancy - Previous failure of fertilization with ICSI - A previous ART attempt in which there were no adequate or motile sperm before or after the processing of ejaculated sperm - Previous severe OHSS - History or presence of tumors of the hypothalamus or pituitary gland - History or presence of ovarian, uterine or mammary cancer - History or presence of ovarian enlargement or cyst of unknown etiology, or presence of ovarian cyst >25 mm on the day of randomization - Presence of endometriosis Grade III - IV - Presence of uni- or bilateral hydrosalpinx - Abnormal gynecological bleeding of undetermined origin - Contraindication to being pregnant and/or carrying a pregnancy to term - History of >= 3 clinical or preclinical (absence of gestational sac) miscarriages due to any cause - Extra-uterine pregnancy within the 3 months prior to randomization - Clinically significant concurrent disease that would have compromised subject safety or interfered with the study assessments - Known infection with human immunodeficiency virus (HIV), hepatitis B or C virus in the female or male partner - Known allergy or hypersensitivity to human gonadotrophin preparations or to compounds that are structurally similar to any of the other medications administered during the study - Any medical condition, which in the judgment of the Investigator may have interfere with the absorption, distribution, metabolism or excretion of r-hFSH - Any active substance abuse or history of drug, medication or alcohol abuse within 5 years before screening - ART cycle and/or ovarian stimulation within 30 days prior to informed consent - Entered previously into this study or simultaneous participation in another clinical trial - Subject is a smoker consuming more than 5 cigarettes per day - In the opinion of the Investigator, either assisted hatching or pre-implantation genetic diagnosis is indicated for the subject - Planning to undergo experimental procedures such as blastomere biopsy, or - Any known autoimmune disease |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Local US Medical Information Office | Rockland | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Merck KGaA |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Fertilized Oocytes (2 Pronuclei [PN]) | Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN. | Ovum pick-up (OPU) day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 21 days}]) | No |
Secondary | Percentage of Participants With Clinical Pregnancy | Clinical pregnancy was defined as the presence of one or more fetal sacs with fetal heart activity on the Day 35-42 post r-hCG ultrasound examination. | Day 35-42 post r-hCG administration day (end of stimulation cycle [approximately 21 days]) | No |
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