Plain English Summary
Background and study aims
In vitro fertilisation (IVF) is a technique used to help people with fertility problems to have a baby. During IVF, the egg is fertilised by the sperm outside of the body to create an embryo and then returned to the woman’s uterus to develop. Although IVF has become more and more successful in recent years, there is still a relatively high failure rate. The exact reasons for this are not known, however recent studies suggest that levels of different hormones in the body could play a role. The production of different hormones is determined by genes, which can vary greatly from person to person. The aim of this study is to find out whether there is a relationship between the different variants of hormonal genes and the success of IVF treatment.
Who can participate?
Women aged 20 to 45 who are suitable for IVF treatment.
What does the study involve?
All of the participants undergo standard IVF treatment and donate 10 ml of blood for the genetic variants tests.
What are the possible benefits and risks of participating?
There are no additional benefits or risks for those taking part in the study as the treatment process is the same for those who are and are not taking part in the study.
Where is the study run from?
Lee Women's Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
December 2013 to December 2016
Who is funding the study?
United Arab Emirates University (United Arab Emirates)
Who is the main contact?
Dr Tsung-Hsien Lee
jackth.lee@gmail.com
Study website
Contact information
Type
Scientific
Contact name
Dr Tsung-Hsien Lee
ORCID ID
Contact details
Chung Shan Medical Unviersity Hospital
No.110 Sec.1
Jianguo N.Rd.
Taichung
402
Taiwan
+886 (0)4 24739595 (ext 20723)
jackth.lee@gmail.com
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The research of gene polymorphisms of hormonal signals genes in women entering in vitro fertilization program
Acronym
Study hypothesis
The outcome of in vitro fertilization (IVF) cycles is associated with hormonal genetic variants.
Ethics approval(s)
Institutional Review Board of Chung Shan Medical University Hospital, 12/11/2013, ref: CS13194
Study design
Single-centre observational prospective cohort study
Primary study design
Observational
Secondary study design
Cohort study
Study setting(s)
Hospital
Study type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
In vitro fertilization (IVF)
Intervention
All participating patients received controlled ovarian hyperstimulation protocols and oocyte retrieval procedures to get a number of oocytes. These oocytes were processed with in vitro fertilization/intracytoplasmic sperm injection to get embryos. Then we transferred the embryos back into the uterus. The duration of observation is at least one month. If a patient became pregnant, we followed her up for about one year until the delivery of baby.
Intervention type
Mixed
Primary outcome measure
Oocyte number, measured using microscopy observation at the time of oocyte retrieval
Secondary outcome measures
1. Embryo quality is measured using microscopy observation for the number of blastomere, fragmentation degree at day 3 or day 5 after oocyte retrieval
2. Pregnancy rate is measured using serum beta-HCG test and ultrasound examination at 18 days and 32 days after oocyte retrieval, respectively
3. Implantation rate is measured using the total sac numbers divided by total transfer embryo number at the time of ultrasound examination
Overall study start date
16/12/2013
Overall study end date
15/12/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 20 to 45 years old
2. Infertile patients who need IVF treatment
3. Qualified for IVF treatment
Participant type(s)
Patient
Age group
Adult
Sex
Female
Target number of participants
2000
Participant exclusion criteria
1. Part of the oocyte donation program
2. Part of the sperm donation program
Recruitment start date
23/12/2013
Recruitment end date
15/12/2015
Locations
Countries of recruitment
Taiwan
Study participating centre
Lee Women's Hospital
263 Pei-Tun Road
Pei-Tun Strict
Tiachung
402
Taiwan
Sponsor information
Organisation
Chung Shan Medical Unviersity Hospital
Sponsor details
No.110 Sec.1
Jianguo N.Rd.
Taichung
402
Taiwan
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Hospital/treatment centre
Funder name
Chung Shan Medical University Hospital
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
Taiwan
Results and Publications
Publication and dissemination plan
Planned publication of several papers about the ovarian response, pregnancy, and implantation process in peer-reviewed journals.
Intention to publish date
30/06/2016
Individual participant data (IPD) sharing plan
The data-sharing plans for the current study are unknown and will be made available at a later date
IPD sharing plan summary
Data sharing statement to be made available at a later date
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 19/02/2019 | No | No | ||
| Results article | 08/03/2019 | 15/02/2023 | Yes | No | |
| Results article | 30/06/2021 | 15/02/2023 | Yes | No |