Observational Prospective Study of the Success of Single Embryo Transfer Implantation Related to Level of Follicular Fluid Cytokines Expression in Low Responders Infertile Patients Treated With r-hLH add-on Therapy in a Second Controlled Ovarian Stimulation Cycle.
NCT ID: NCT02640261
Last Updated: 2016-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2016-01-31
2018-04-30
Brief Summary
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100 IVF infertile patients , aged 32-39 years, with normal ovarian reserve, previously stimulated for their first cycle with standard short protocol (GnRH-Ant) and r-FSH alone, who have had a low ovarian response, Fort \< 50% ( FORT Criteria, 2012; FORT= PFCX100/AFC), will be treated for the second cycle with standard short protocol (GnRH-Ant) and r-FSH plus r-LH , according to the standard established by our clinical practice.
Patients will be part of one of the following groups:
Group 1: single embryo transfer on day 5, according to standard embryo morphological criteria Group 2: single embryo transfer on day 5, chosen on the basis of both embryo morphological criteria and levels of cytokines measured in the individual FF.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group 1
Single embryo transfer on day 5, according to standard embryo morphological criteria
No interventions assigned to this group
Group 2
Single embryo transfer on day 5, chosen on the basis of both embryo morphological criteria and levels of cytokines measured in the individual FF.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* normal body mass index (BMI ) from 18 to 26
* parameters for ovarian reserve in the normal range (day 3 FSH levels \< 10 mUI/ml ; day 3 E2 levels \< 80 pg/ml; anti-mullerian hormone (AMH) levels \> 1.5 ng/ml ; AFC (antral follicular count) \> 6 )
Exclusion Criteria
* ovarian surgery
* pelvic endometriosis
* POR according to ESHRE criteria
18 Years
38 Years
FEMALE
No
Sponsors
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Centro di Procreazione Assistita Demetra
OTHER
Responsible Party
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Principal Investigators
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Elisabetta Chelo, MD
Role: PRINCIPAL_INVESTIGATOR
Clinica Center DEMETRA
Locations
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DEMETRA
Florence, Italy, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Echelo
Identifier Type: -
Identifier Source: org_study_id
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