Retrospective Trial on Low Prognosis Infertile Patients

September 22, 2017 updated by: Istituto Clinico Humanitas

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

26883

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
induction protocol type
Time Frame: 6 years
number of antagonist and agonist protocols/ total numbers
6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fertilization Rate
Time Frame: 6 years
fertilized oocytes/ number of oocytes used
6 years
Pregnancy Rate
Time Frame: 6 years
number of gestational sacs/ number of embryos transferred
6 years
Ongoing Pregnancy Rate
Time Frame: 6 years
number of pregnancy > 20 weeks/ total pregnancies
6 years
Live Birth Rate
Time Frame: 6 years
number babies born/ total pregnancies
6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Collaborators

Merck Serono International SA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2010

Primary Completion (Actual)

December 31, 2015

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

September 19, 2017

First Submitted That Met QC Criteria

September 19, 2017

First Posted (Actual)

September 25, 2017

Study Record Updates

Last Update Posted (Actual)

September 25, 2017

Last Update Submitted That Met QC Criteria

September 22, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15/17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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