The association of genetic variants and outcome of in vitro fertilization cycles
| ISRCTN | ISRCTN12768989 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12768989 |
| Protocol serial number | N/A |
| Sponsor | Chung Shan Medical Unviersity Hospital |
| Funder | Chung Shan Medical University Hospital |
- Submission date
- 22/12/2015
- Registration date
- 07/01/2016
- Last edited
- 05/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
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 years 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
Contact information
Scientific
Chung Shan Medical Unviersity Hospital
No.110 Sec.1
Jianguo N.Rd.
Taichung
402
Taiwan
| Phone | +886 (0)4 24739595 (ext 20723) |
|---|---|
| jackth.lee@gmail.com |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre observational prospective cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | The research of gene polymorphisms of hormonal signals genes in women entering in vitro fertilization program |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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(s) | Oocyte number, measured using microscopy observation at the time of oocyte retrieval |
| Key secondary outcome measure(s) | 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 |
| Completion date | 15/12/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 45 Years |
| Sex | Female |
| Target sample size at registration | 2000 |
| Total final enrolment | 1744 |
| Key inclusion criteria | 1. Age 20 to 45 years old 2. Infertile patients who need IVF treatment 3. Qualified for IVF treatment |
| Key exclusion criteria | 1. Part of the oocyte donation program 2. Part of the sperm donation program |
| Date of first enrolment | 23/12/2013 |
| Date of final enrolment | 15/12/2015 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
Pei-Tun Strict
Tiachung
402
Taiwan
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 08/03/2019 | 15/02/2023 | Yes | No | |
| Results article | 30/06/2021 | 15/02/2023 | Yes | No | |
| Results article | 19/01/2023 | 05/02/2025 | Yes | No | |
| Basic results | 19/02/2019 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Additional files
Editorial Notes
05/02/2025: Publication reference and total final enrolment added.
15/02/2023: Publication references added.
19/02/2019: The basic results of this trial have been uploaded as an additional file.
