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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03927417

Recruitment Status Recruiting

First Posted April 25, 2019

Last update posted September 9, 2020

Study Description

Brief summary:

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.

  • Condition or Disease:Infertility
  • Intervention/Treatment:
  • Phase: N/A
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 Design
  • Study Type: Observational
  • Estimated Enrollment: 1000 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Influence of Ethnical Differences on the Oocyte Yield in Patients Undergoing IVF / ICSI Treatment in Different Countries
  • Actual Study Start Date: April 2019
  • Estimated Primary Completion Date: October 2020
  • Estimated Study Completion Date: December 2020
Outcome Measures
  • Primary Outcome Measures: 1. Number of retrieved oocytes [ Time Frame: 1 day ]
    Number of retrieved oocytes
  • 2. Number of mature oocytes [ Time Frame: 1 day ]
    Number of mature oocytes
  • 3. 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)
Eligibility Criteria
  • Ages Eligible for Study: (Child, Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
  • Sampling Method: Non-Probability Sample
  • Study Population: Couples with primary / secondary infertility who are planned to undergo IVF / ICSI treatment
Criteria

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

Contacts and Locations
Contacts

Contact: Barbara Lawrenz, PhD +97126528000 ext 1108 barbara.lawrenz@ivirma.com

Contact: Shieryl Digma, RN +97126528000 ext 1122 shieryl.digma@ivirma.com

Locations

United Arab Emirates
IVI Middle East Fertility Clinic
Abu Dhabi

Sponsors and Collaborators

IVI Middle East Fertility Clinic

Investigators

Principal Investigator: Barbara Lawrenz, PhD IVI RMA Abu Dhabi

More Information