NCT03020173

Brief Summary

This study aims to discover the connection between BMI and oocyte and granulosa consistencies.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2017

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

January 13, 2017

Status Verified

January 1, 2017

Enrollment Period

1 year

First QC Date

January 2, 2017

Last Update Submit

January 11, 2017

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

  • Measurement of composition of granulosa cells and oocytes

    Laboratory measurement of lipid and cholesterol amounts, mitochondrial distribution and telomere length according to BMI levels

    One year

Study Arms (2)

BMI above 30

Oocytes and granulosa of infertile women with BMI above 30

Other: Laboratory study

BMI below 30

Oocytes and granulosa of infertile women with BMI above 30

Other: Laboratory study

Interventions

Laboratory studyOTHER

Laboratory analysis to determine composition of granulosa and oocytes

BMI above 30BMI below 30

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Infertile women undergoing IVF treatment

You may qualify if:

  • Infertile women undergoing IVF
  • Consent to participate in study

You may not qualify if:

  • Fertility preservation due to cancer
  • Endocrine disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Central Study Contacts

Rinat Lift, MSc

CONTACT

rinatl@hy.health.gov.il

Shira Raviv, MD

CONTACT

drshiraraviv@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2017

First Posted

January 13, 2017

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

July 1, 2018

Last Updated

January 13, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share