NCT03290911

Retrospective Trial on Low Prognosis Infertile Patients

An Observational Retrospective Cohort Trial on Low Prognosis Infertile Patient's Accessing IVF Cycle Management

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 26,883 (actual)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Not accepted

Summary

The main objective of this study is to analyze management of Controlled Ovarian Stimulation (COS) protocols in low prognosis patients, secondly to observe the clinical outcomes (Fertilization Rate, Pregnancy Rate, the Ongoing Pregnancy Rate and the Live birth Rate) and the total units of gonadotrophins consume per M2 oocyte retrieved in this subgroup.

Detailed description

Humanitas Fertility Center maintains an external audit anonymized electronic research queries system, exported from a certified only access web database, which at time of this analysis (cycles at December 31th 2016) include 26,883 consecutive fresh non-donors IVF cycles. Patients who underwent these cycles had consented in writing that their medical records could be used for research purposes, as long as the patients' anonymity was protected and confidentiality of the medical record was assured. Since both of these conditions were met, this study has been approved on March 2th 2017 with an expedited review and approval protocol by the center's Institutional Review Board (IRB). At least 2,000 expected low prognosis patients in the Humanitas Fertility Center Database out of 12,545 cycles performed in the period 2010-2015 with completed pregnancy follow-up.

Conditions

• Infertility, Female
• Fertility Disorders

Timeline

• Start date: 2010-01-01
• Primary completion: 2015-12-31
• Completion: 2017-09-01
• First posted: 2017-09-25
• Last updated: 2017-09-25