Clinical trial NCT03927417: Influence of Ethnical Differences on the Egg Cell Collected in Patients Undergoing Fertility Treatment
Official title: Influence of Ethnical Differences on the Oocyte Yield in Patients Undergoing IVF / ICSI Treatment in Different Countries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: oocyte yield
ethnicity
ovarian stimulation
Lead sponsor: ART Fertility Clinics LLC
Sponsor class: OTHER
First posted: 2019-04-25
Enrollment: 1117
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Couples with primary / secondary infertility who are planned to undergo IVF / ICSI treatment

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of retrieved oocytes
timeFrame: 1 day
measure: Number of mature oocytes
timeFrame: 1 day
measure: Fertilization rate
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: IVI Middle East Fertility Clinic
Study officials:
affiliation: IVI RMA Abu Dhabi
name: Barbara Lawrenz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.