Convenience and Safety of Assisted Reproductive Technology Procedures Using a Gonal-F Filled by Mass (Fbm) Liquid Formulation Applied by Pen for Ovulation Induction and In-vitro Fertilization
NCT ID: NCT01183143
Last Updated: 2018-04-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
215 participants
INTERVENTIONAL
2004-05-11
2006-03-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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GONAL-f®
GONAL-f®
GONAL-f® will be administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who undergo ovulation induction (OI)/artificial insemination (IUI) and between 150 and 225 IU per day for subjects who undergo in-vitro fertilization (IVF). For subjects who undergo OI/IUI, the dose will be increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response is observed.
Interventions
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GONAL-f®
GONAL-f® will be administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who undergo ovulation induction (OI)/artificial insemination (IUI) and between 150 and 225 IU per day for subjects who undergo in-vitro fertilization (IVF). For subjects who undergo OI/IUI, the dose will be increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response is observed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ambulatory subjects
* Subjects who are willing to get pregnant and are infertile, that justifies ovarian stimulation treatment for mono-/pauci-follicular development (OI or IUI) or multiple follicular development for IVF/Intracytoplasmic Sperm Injection (ICSI) procedures
* Subjects who are able to communicate well with the investigator and to comply with the requirements of the entire study
* Subjects who have given written informed consent, prior to treatment
Exclusion Criteria
* Subjects with extra-uterine pregnancy during the last 3 months
* Subjects with several endometriosis (Grade III \& IV)
* Subjects with history of severe ovarian hyperstimulation syndrome
* Subjects with history of thromboembolic event
* Subjects with malformative uterine pathology that could disturb either implantation or pregnancy processes
* Subjects with premature menopause
* Subjects with gynecological bleeding of unknown origin
* Subjects with ovarian, uterine, or mammary cancer
* Subjects with tumors of the hypothalamus or the pituitary glands
* Subjects with history of serious allergy or atopic asthma disease
* Subjects with known allergic reaction against one of the Follicle Stimulating Hormone (FSH) and ingredients,
* Ongoing pregnant, or breast feeding subjects
* Subjects who have participated in a trial during the last 3 months
18 Years
43 Years
FEMALE
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
Merck KGaA, Darmstadt, Germany
Locations
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Please Contact the Merck KGaA Communication Center
Darmstadt, , Germany
Countries
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Other Identifiers
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IMP 25040
Identifier Type: -
Identifier Source: org_study_id
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