Infertility Clinical Trial
Official title:
A Randomized Controlled Trial to Compare the Efficacy Between Pergoveris and Follitropin Alfa in Ovarian Stimulation in Patients Aged ≥ 35 Years
To compare the efficacy between LH supplementation (Pergoveris) and non-LH supplementation
(Follitropin alpha) in patients aged ≥ 35 years undergoing IVF treatment.
Study hypothesis: Pergoveris (LH supplementation) is better than follitropin alpha (non-LH
supplementation) for ovarian stimulation in aged IVF patients.
Status | Completed |
Enrollment | 240 |
Est. completion date | June 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 35 Years to 45 Years |
Eligibility |
Inclusion Criteria: - age = 35 years - body mass index <28 kg/m2 - had = 3 previous IVF attempts - receiving a GnRH-antagonist protocol - agreement to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study. - have given written informed consent with the understanding that the subject may withdraw consent at any time Exclusion Criteria: - participating in another interventional clinical trial - PCOS or WHO group 1 - have uterine abnormalities - have endocrine disorders such as hyperprolactinemia, thyroid disorders |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Vietnam | An Sinh Hospital | Ho Chi Minh |
Lead Sponsor | Collaborator |
---|---|
Vietnam National University |
Vietnam,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Clinical pregnancy | Clinical pregnancy is defined by the image gestational sac under ultrasonography. | 7 weeks after embryo transfer | No |
Primary | Live birth | Live birth is defined if a live newborn delivered. | at the time of delivery | No |
Secondary | Total FSH international units (IU) used for stimulation | Calculate total number of IU of FSH used for stimulation at the last day of stimulation regime. | Measure at the time when stimulation finishes, eg. in average 10-11 days, maximum 20 days | No |
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