Cumulative Live Birth Rate (CLBR) After a Complete IVF Cycle: a Single Center Retrospective Study

Cumulative Live Birth Rate (CLBR) After a Complete IVF Cycle: a Single Center

We need to identify a new parameter to evaluate the success rate of IVF techniques. CLBR has been suggested as a suitable way for reporting success of IVF program: it implies capturing the totality of live birth episodes following successive treatments. For patients CLBR is easy to understand because it summarizes the chance of a live birth over an entire treatment period. CLBR per oocyte retrieval is more meaningful as it is the best indicator of quality and success in IVF and it allows the best indicator of quality and success in IVF with different strategies for freezing embryos.

Study Overview

• Status: Completed
• Conditions: Fertility Disorders; ART
• Intervention / Treatment: Drug: Controlled ovarian stimulation

Detailed Description

Traditionally, studies about In Vitro Fertilization (IVF) examine and report the 'per cycle' and 'per embryo transfer procedure' probability of pregnancy and delivery .Thus, each IVF cycle is considered as a unique entity even if several embryo transfers (ET) have been performed after a single ovarian stimulation.

Thanks to the latest technological refinements, in recent years the number of thawed frozen ETs has greatly increased and has become an essential feature of IVF procedures .This practice has been encouraged by the strategy of preferring single ET for reducing multiple pregnancy and preventing ovarian hyperstimulation in high risk women.

Moreover, at first infertility counseling patients usually want to know which is their possibility to have a live birth child with ART treatment, after the first stimulation cycle, also involving the chances after frozen ET or frozen oocytes injection.

Live birth rate (LBR) after a single fresh or frozen ET appears, at present time, to be an insufficient parameter for a realistic evaluation of the efficacy of an IVF program.

We need to identify a new parameter for the evaluation of the success rate of IVF techniques which should incorporate outcomes associated with a single controlled ovarian stimulation cycle. Specifically, Cumulative live birth rate (CLBR) has been suggested as a suitable way for reporting success of IVF program : it implies capturing the totality of live birth episodes following successive treatments.

For patients CLBR is very reliable and easy to understand because it summarizes the chance of a live birth over an entire treatment period . CLBR per oocyte retrieval is more meaningful as it is the best indicator of quality and success in IVF and it allows the best indicator of quality and success in IVF with different strategies for freezing embryos.

The aim of the present study was to report our experience on CLBR after the first stimulation cycle and to determinate which prognostic factors contribute to positive pregnancy outcomes.

• Study Type: Observational
• Enrollment (Actual): 6375

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

All patients admitted to Humanitas Research hospital for undergoing their first IVF cycle , except cycle with any pre-implatation genetic test

Description

Inclusion Criteria:

• All patients admitted to Humanitas Research hospital for undergoing their first IVF cycle

Exclusion Criteria:

• cycle with any pre-implatation genetic test

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
women < 35 years old	Drug: Controlled ovarian stimulation; Hormonal therapy to induce ovulation by multiple ovarian follicles
women between 36 and 38 years old	Drug: Controlled ovarian stimulation; Hormonal therapy to induce ovulation by multiple ovarian follicles
women between 39 and 40 years	Drug: Controlled ovarian stimulation; Hormonal therapy to induce ovulation by multiple ovarian follicles
women > 41 years old	Drug: Controlled ovarian stimulation; Hormonal therapy to induce ovulation by multiple ovarian follicles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Live Birth Rate	number of live Birth derived from a complete controlled ovarian stimulation	2 years

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): December 31, 2015
• Study Completion (Actual): December 31, 2015

Study Registration Dates

• First Submitted: January 28, 2019
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 28, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: CLBR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No