- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03927417
Influence of Ethnical Differences on the Egg Cell Collected in Patients Undergoing Fertility Treatment
Influence of Ethnical Differences on the Oocyte Yield in Patients Undergoing IVF / ICSI Treatment in Different Countries
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
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Abu Dhabi, Forenede Arabiske Emirater, 60202
- IVI Middle East Fertility Clinic
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of retrieved oocytes
Tidsramme: 1 day
|
Number of retrieved oocytes
|
1 day
|
|
Number of mature oocytes
Tidsramme: 1 day
|
Number of mature oocytes
|
1 day
|
|
Fertilization rate
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Barbara Lawrenz, PhD, IVI RMA Abu Dhabi
Publikationer og nyttige links
Generelle publikationer
- Inhorn MC, Patrizio P. Infertility around the globe: new thinking on gender, reproductive technologies and global movements in the 21st century. Hum Reprod Update. 2015 Jul-Aug;21(4):411-26. doi: 10.1093/humupd/dmv016. Epub 2015 Mar 22.
- 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, Brannstrom M, Donnez J, Silber S, Dolmans MM, Simpson JL, Handyside AH, Munne 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.
- Baker VL, Luke B, Brown MB, Alvero R, Frattarelli JL, Usadi R, Grainger DA, Armstrong AY. Multivariate analysis of factors affecting probability of pregnancy and live birth with in vitro fertilization: an analysis of the Society for Assisted Reproductive Technology Clinic Outcomes Reporting System. Fertil Steril. 2010 Sep;94(4):1410-1416. doi: 10.1016/j.fertnstert.2009.07.986. Epub 2009 Sep 9.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 1901-ABU-012-BL
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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