Retrospective Trial on Low Prognosis Infertile Patients

Completed

• Conditions: Fertility Disorders; Infertility, Female

• Registration Number: NCT03290911
• Lead Sponsor: Istituto Clinico Humanitas

Brief 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.

Study Timeline

• Study Start: 2010-01-01
• Primary Completion: 2015-12-31
• Status Verified: 2017-09
• Study Completion: 2017-09-01
• Study First Submitted: 2017-09-19
• Study First Submitted QC: 2017-09-19
• Last Update Submitted: 2017-09-22
• Study First Posted: 2017-09-25
• Last Update Posted: 2017-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 26883

Inclusion Criteria

• Age ≤ 44
• Body Mass Index; 18 ≤ BMI ≥ 27
• Number of oocytes retrieved ≤ 9
• Cycles performed between January 2010 - December 2015

Exclusion Criteria

• Age > 44
• Number of oocytes retrieved ≥ 10
• Abnormal uterine cavity
• Endometriosis III-IV stage or adenomyosis
• Testicular spermatozoa PGS (Preimplantation Genetic Screening) cycles

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
induction protocol type	6 years	number of antagonist and agonist protocols/ total numbers

Secondary Outcome Measures

Name	Time	Method
Fertilization Rate	6 years	fertilized oocytes/ number of oocytes used
Pregnancy Rate	6 years	number of gestational sacs/ number of embryos transferred
Live Birth Rate	6 years	number babies born/ total pregnancies
Ongoing Pregnancy Rate	6 years	number of pregnancy \> 20 weeks/ total pregnancies