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

Completed

• Conditions: ART; Fertility Disorders
• Interventions: Drug: Controlled ovarian stimulation

• Registration Number: NCT03822429
• Lead Sponsor: Istituto Clinico Humanitas

Brief Summary

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.

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 Timeline

• Study Start: 2010-01-01
• Primary Completion: 2015-12-31
• Study Completion: 2015-12-31
• Status Verified: 2019-01
• Study First Submitted: 2019-01-28
• Study First Submitted QC: 2019-01-28
• Last Update Submitted: 2019-01-28
• Study First Posted: 2019-01-30
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 6375

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
women < 35 years old	Controlled ovarian stimulation	-
women between 39 and 40 years	Controlled ovarian stimulation	-
women > 41 years old	Controlled ovarian stimulation	-
women between 36 and 38 years old	Controlled ovarian stimulation	-

Primary Outcome Measures

Name	Time	Method
Cumulative Live Birth Rate	2 years	number of live Birth derived from a complete controlled ovarian stimulation