Condition category
Pregnancy and Childbirth
Date applied
22/12/2015
Date assigned
07/01/2016
Last edited
11/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Hospitals

Trial 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

Phase

Drug names

Primary outcome measures

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 trial start date

16/12/2013

Overall trial end date

15/12/2016

Reason abandoned

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

Patient

Age group

Adult

Gender

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

Trial 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

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

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

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes