InfertilityNCT03927417
Influence of Ethnical Differences on the Egg Cell Collected in Patients Undergoing Fertility Treatment
An observational study of Infertility, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Infertility
- How many people
- 1,117 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 30 Apr 2019to 31 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Couples with primary / secondary infertility who are planned to undergo IVF / ICSI treatment
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
IVI Middle East Fertility Clinic
Abu Dhabi, 60202
About this study
Official title: 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.
Read the 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.
- Conditions
- Infertility
- Keywords
- oocyte yield, ethnicity, ovarian stimulation
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of retrieved oocytes
Number of retrieved oocytes
Measured: 1 day
Number of mature oocytes
Number of mature oocytes
Measured: 1 day
Fertilization rate
Fertilization rate (% of fertilized oocytes per metaphase II oocytes injected in case of ICSI / per metaphase II oocytes inseminated in case of IVF)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start30 Apr 2019
- Primary completion29 Sep 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,117 participants (actual)
Sponsor and investigators
- Lead sponsor
- ART Fertility Clinics LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barbara Lawrenz, ART Fertility Clinics LLC
- Investigators
- Barbara Lawrenz, PhD, Principal investigator, IVI RMA Abu Dhabi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03927417
- Sponsor's protocol ID
- 1901-ABU-012-BL
- Status last verified
- Jan 2021
- First submitted
- 23 Apr 2019
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25801630Niederberger 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.
PubMed 30053940Baker 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.
PubMed 19740463
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Ethnical Differences on the Oocyte Yield in Patients Undergoing IVF / ICSI Treatment in Different Countries
- ClinicalTrials.gov ID
- NCT03927417
- Acronym / sponsor ID
- 1901-ABU-012-BL
- Conditions
- Infertility
- Keywords
- oocyte yield, ethnicity, ovarian stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,117 participants (actual)
- Lead sponsor
- ART Fertility Clinics LLCUniversity, hospital or other
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 25 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Couples with primary / secondary infertility who are planned to undergo IVF / ICSI treatment
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of retrieved oocytes
Time frame: 1 day
Number of retrieved oocytes
Number of mature oocytes
Time frame: 1 day
Number of mature oocytes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Background: PubMed 25801630Inhorn 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.
- Background: PubMed 30053940Niederberger 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.
- Background: PubMed 19740463Baker 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Lawrenz, PhD principal investigator
IVI RMA Abu Dhabi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of retrieved oocytes (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03927417, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2021.