Brief Summary

In this study, the investigators will evaluate genetic variation or polymorphisms between individuals submitted to IVF/ICSI cycles, and how these variations influence response to COS and pregnancy outcomes. Thus, this project has the aim to develop a pharmacogenetic algorithm associating gene polymorphisms, the patient clinical information, and functional and hormonal biomarker to: 1) predict the patient response to gonadotropin; 2) develop individualized gonadotropin regimens; 3) improve the accuracy of determining appropriate dosages of gonadotrophins; 4) improve efficacy and patient compliance to COS; and finally 5) reduce the time-to-pregnancy.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

1,350

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Nov 2020

Typical duration for not_applicable

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.1 years study duration

First Submitted

Initial submission to the registry

May 4, 2017

Completed

7 days until next milestone

First Posted

Study publicly available on registry

May 11, 2017

Completed

3.5 years until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed

Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

1.1 years

First QC Date

May 4, 2017

Last Update Submit

July 14, 2020

Conditions

Infertility

Keywords

pharmacogeneticpharmacogenomicpolymorphismindividualized controlled ovarian stimulationalgorithmassisted reproduction

Outcome Measures

Primary Outcomes (1)

Number of retrieved oocytes
The number of retrieved oocytes during an IVF treatment
It will be assessed on the 22th month after the first patient recruitment

Secondary Outcomes (8)

Number of mature oocytes
It will be assessed on the 22th month after the first patient recruitment
Embryo quality - morphological classification
It will be assessed on the 22th month after the first patient recruitment
Ovarian Hyperstimulation Syndrome
It will be assessed on the 22th month after the first patient recruitment
Pregnancy Rate
It will be assessed on the 22th month after the first patient recruitment
Clinical Pregnancy Rate
It will be assessed on the 22th month after the first patient recruitment
+3 more secondary outcomes