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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03927417
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : September 9, 2020
Sponsor:
Information provided by (Responsible Party):
Barbara Lawrenz, IVI Middle East Fertility Clinic

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

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.

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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 30, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020



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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927417


Contacts
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Contact: Barbara Lawrenz, PhD +97126528000 ext 1108 barbara.lawrenz@ivirma.com
Contact: Shieryl Digma, RN +97126528000 ext 1122 shieryl.digma@ivirma.com

Locations
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United Arab Emirates
IVI Middle East Fertility Clinic Recruiting
Abu Dhabi, United Arab Emirates, 60202
Contact: Barbara Lawrenz, PhD    +97102 652 8000 ext 1108    shieryl.digma@ivirma.com   
Contact: Shieryl Digma, RN    +97102 652 8000 ext 1122    shieryl.digma@ivirma.com   
Principal Investigator: Barbara Lawrenz, PhD         
Sponsors and Collaborators
IVI Middle East Fertility Clinic
Investigators
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Principal Investigator: Barbara Lawrenz, PhD IVI RMA Abu Dhabi
Additional Information:
Publications:
Niederberger C, Pellicer A, Cohen J, Gardner DK, Palermo GD, O'Neill CL, Chow S, Rosenwaks Z, Cobo A, Swain JE, Schoolcraft WB, Frydman R, Bishop LA, Aharon D, Gordon C, New E, Decherney A, Tan SL, Paulson RJ, Goldfarb JM, Brännström M, Donnez J, Silber S, Dolmans MM, Simpson JL, Handyside AH, Munné S, Eguizabal C, Montserrat N, Izpisua Belmonte JC, Trounson A, Simon C, Tulandi T, Giudice LC, Norman RJ, Hsueh AJ, Sun Y, Laufer N, Kochman R, Eldar-Geva T, Lunenfeld B, Ezcurra D, D'Hooghe T, Fauser BCJM, Tarlatzis BC, Meldrum DR, Casper RF, Fatemi HM, Devroey P, Galliano D, Wikland M, Sigman M, Schoor RA, Goldstein M, Lipshultz LI, Schlegel PN, Hussein A, Oates RD, Brannigan RE, Ross HE, Pennings G, Klock SC, Brown S, Van Steirteghem A, Rebar RW, LaBarbera AR. Forty years of IVF. Fertil Steril. 2018 Jul 15;110(2):185-324.e5. doi: 10.1016/j.fertnstert.2018.06.005. Review.

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Responsible Party: Barbara Lawrenz, Scientific Director, IVI Middle East Fertility Clinic
ClinicalTrials.gov Identifier: NCT03927417    
Other Study ID Numbers: 1901-ABU-012-BL
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: September 9, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Barbara Lawrenz, IVI Middle East Fertility Clinic:
oocyte yield
ethnicity
ovarian stimulation
Additional relevant MeSH terms:
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Infertility