Infertility Clinical Trial
Official title:
Prospective Randomized Study for the Evaluation of Controlled Ovarian Stimulation With Corifollitropin Alpha in Patients With Expected or Poor Ovarian Response in IVF Cycles
Verified date | September 2016 |
Source | Instituto de Investigacion Sanitaria La Fe |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients who have had or are expected to have a poor ovarian response (POR), because they
meet any of the criteria of Bologna, can benefit from ovarian stimulation with 150 mg of
alpha Corifollitropin (CFA) (Elonva ®) as single dose for a week, in the cycles of in vitro
fertilization (IVF).
In this study aims to demonstrate non-inferiority of the Corifollitropin Alpha (CFA ) versus
daily administration of Human Menopausal Gonadotropin (hMG) (Menopur ®) during the first
seven days of ovarian stimulation, in a protocol with gonadotropin-releasing hormone ( GnRH)
antagonists
Status | Completed |
Enrollment | 234 |
Est. completion date | June 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: 1. - Age = 18 years old. 2. - Signed informed consent to perform IVF and participation in this study. 3. - Due to characteristics of our center not perform treatments in patients - 40 years old ,and being one of the Bologna criteria that we will not be able to consider ,we decided to include patients affected subsidiary infertility treatment by IVF or intracytoplasmatic sperm injection (ICSI), present one of the following factors 1. Have a history of surgical or medical treatment as a risk factor for POR. 2. Patients witch had have a poor ovarian response in response to the ovarian controlled stimulation (previous cycle after conventional stimulation with = 3 oocytes) 3. Patients with ovarian reserve test anti-mullerian hormone(AMH ) <1.1 ng / ml (<8 pM) or antral follicle count (AFC)<7 Exclusion Criteria: 1. -Anovulation. 2. -Patient with tubal factor, untreated 3. -Patient with uterine pathology untreated 4. - Couples with severe male factor, fresh count <5 million / ml, and azoospermia in which the patient's sperm, epididymal or testicular is used |
Country | Name | City | State |
---|---|---|---|
Spain | Human Reproduction Unit of the La Fe University and Politechnic Hospital | Valencia |
Lead Sponsor | Collaborator |
---|---|
Instituto de Investigacion Sanitaria La Fe |
Spain,
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of evolutionary gestation in each cycle | Evolutionary pregnancy has been defined as gestation of at least 1 fetus reaches 20 weeks of gestation diagnosed by normal ultrasound or confirmed by live birth | 20 week of gestation | |
Primary | oocytes (MII) rate by patient | When follicular puncture occurs, we value the number of punctured follicles, total oocytes and MII oocytes | participants will be followed for the duration of the cycle,an expected average of 8-16 days. | |
Secondary | Number of Participants with Adverse Events | participants will be followed for the duration of the cycle,an expected average of 16 days. |
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