Retrospective Trial on Low Prognosis Infertile Patients

Infertility, Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03290911
• Other study ID #: 15/17
• Status: Completed
• Phase: N/A
• First received: September 19, 2017
• Last updated: September 22, 2017
• Start date: January 1, 2010
• Est. completion date: September 1, 2017

Study information

• Verified date: September 2017
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26883
• Est. completion date: September 1, 2017
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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

Related Conditions & MeSH terms

• Fertility Disorders
• Infertility
• Infertility, Female

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas	Merck Serono International SA

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	induction protocol type	number of antagonist and agonist protocols/ total numbers	6 years
Secondary	Fertilization Rate	fertilized oocytes/ number of oocytes used	6 years
Secondary	Pregnancy Rate	number of gestational sacs/ number of embryos transferred	6 years
Secondary	Ongoing Pregnancy Rate	number of pregnancy > 20 weeks/ total pregnancies	6 years
Secondary	Live Birth Rate	number babies born/ total pregnancies	6 years