Influence of Ethnical Differences on the Egg Cell Collected in Patients Undergoing Fertility Treatment

January 7, 2021 updated by: Barbara Lawrenz, ART Fertility Clinics LLC

Influence of Ethnical Differences on the Oocyte Yield in Patients Undergoing IVF / ICSI Treatment in Different Countries

Investigators wants to analyze the differences considering the country of origin, ethnicity, characteristics, reproductive history and habits of participants undergoing in vitro fertilization (IVF) / intracytoplasmic sperm injection (ICSI) treatment as well as the stimulation outcome in regards to stimulation dosages and egg cell yield.

Study Overview

Status

Completed

Conditions

Detailed Description

Infertility is acknowledged worldwide as a major health concern with significant regional differences. The prevalence of infertility in women of reproductive age has been estimated to be one in every seven couples in the western world and one in every four couples in developing countries. Geographical, sociocultural / religious and ethnical dissimilarities contribute to these global variations in infertility prevalence. Infertility has a major impact on family stability in many cultures, especially in developing countries, where childlessness can impact sociocultural status.

So far, most fertility treatments are based on studies performed in Western countries and therefore mostly performed in Caucasian population and research regarding infertility causes and optimal treatments in other populations is scarce. The aim of this prospective study is therefore to analyze the differences in the basic parameters of the populations analyzed, considering the country of origin and ethnicity undergoing IVF/ICSI treatment as well as the stimulation outcome in regards to stimulation dosages and oocyte yield.

Study Type

Observational

Enrollment (Actual)

1117

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Couples with primary / secondary infertility who are planned to undergo IVF / ICSI treatment

Description

Inclusion Criteria:

• Couples with primary / secondary infertility who are planned to undergo IVF / ICSI treatment in one of the above mentioned centers and who agree to take part in this study.

Exclusion Criteria:

  • Couples planned for oocyte and sperm donation
  • Couples in whom the female partner has a history of:
  • Chemotherapy or radiation which impacts the ovarian reserve
  • Surgery at the ovaries / adnex region
  • Tubal ligation
  • Reversal of tubal ligation
  • Endometriosis
  • Couples in whom the male partner has a history of:
  • Chemotherapy / Radiation which impacts the semen result
  • Surgery at the testicles
  • Vasectomy
  • Surgery for reversal of vasectomy

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of retrieved oocytes
Time Frame: 1 day
Number of retrieved oocytes
1 day
Number of mature oocytes
Time Frame: 1 day
Number of mature oocytes
1 day
Fertilization rate
Time Frame: 1 day
Fertilization rate (% of fertilized oocytes per metaphase II oocytes injected in case of ICSI / per metaphase II oocytes inseminated in case of IVF)
1 day

Collaborators and Investigators

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

Sponsor

ART Fertility Clinics LLC

Investigators

  • Principal Investigator: Barbara Lawrenz, PhD, IVI RMA Abu Dhabi

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)

April 30, 2019

Primary Completion (Actual)

September 29, 2020

Study Completion (Actual)

October 31, 2020

Study Registration Dates

First Submitted

April 23, 2019

First Submitted That Met QC Criteria

April 23, 2019

First Posted (Actual)

April 25, 2019

Study Record Updates

Last Update Posted (Actual)

January 8, 2021

Last Update Submitted That Met QC Criteria

January 7, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1901-ABU-012-BL

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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