Establishment of new index for prediction of the implantation success rate, combining the endometrial thickness, the size of the uterus and their ratio

ISRCTN	ISRCTN19411490
DOI	https://doi.org/10.1186/ISRCTN19411490
Secondary identifying numbers	1

Submission date: 18/10/2016
Registration date: 21/11/2016
Last edited: 07/11/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Infertility is a growing problem worldwide. For some couples, the only way to get pregnant is to undergo fertility treatment such as by in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). In these treatments, eggs are taken from women and fertilized outside of the body to create an embryo and then returned to the woman’s womb to develop. In order to give the embryo the best possible chance of attaching to the lining of the womb and developing into a baby, the thickness of the womb lining (endometrium) is measured. Many studies show that there is a relationship between the thickness of the endometrium and the successful pregnancy rate. There is strong evidence also, that in ladies with small wombs, the endrometrium can be thinner and the woman still becomes pregnant. The aim of this study is to combine information about thickness of the endometrium and womb size in order to better predict pregnancy after IVF/ICSI.

Who can participate?
Women aged between 20 and 45 who are undergoing fertility treatment by IVF or ICSI in Vienna In Vitro Center.

What does the study involve?
During routine follow ups after undergoing IVF/ICDI, women have a transvaginal ultrasound on day 2-3, 6-8 and 10-11 of their cycle. This involves having an ultrasound probe placed into the vagina in order to measure the thickness of the endometrium and womb size. Participants have a blood test 10-13 days after the embryos are implanted to see if they are pregnant which is further confirmed by another transvaginal ultrasound after 20-25 days.

What are the possible benefits and risks of participating?
There are no benefits for the patients, except the feeling that they are helping with the advancement of science and improving future services. There are virtually no additional risks for the patients, because the measurements taken are used routinely for the purpose of the IVF/ICSI treatment.

Where is the study run from?
Vienna In Vitro Center (Bulgaria)

When is the study starting and how long is it expected to run for?
June 2016 to December 2017

Who is funding the study?
Vienna In Vitro Center (Bulgaria)

Who is the main contact?
Dr Georgi Stanulov

Contact information

Dr Georgi Stanulov
Public

Tokuda Hospital Sofia, IX floor
Nikola Vaptzarov 51b Blvd
Lozenetz
Sofia
1407
Bulgaria

ORCID ID	0000-0002-8704-1555

Study information

Study design	Prospective cohort study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Diagnostic
Scientific title	Establishment of new index for prediction of the implantation success rate, combining the endometrial thickness, the size of the uterus and their ratio: Prospective analyse in 100 IVF/ICSI cycles
Study objectives	Females present with an inborn variety of uterine size and the uterine size gives a certain limit to the maximum thickness of the endometrium. Measuring the endometrium thickness and its evaluation in combination with the uterine size it is possible to better predict the IVF/ICSI success rate, than using the endometrium thickness measurement alone.
Ethics approval(s)	The study was approved by the Ethic committee of MBAL "Tokuda" Sofia Bulgaria
Health condition(s) or problem(s) studied	Sterility treatment
Intervention	During the routine follow up in their IVF/ICSI cycle, women undergo a transvaginal ultrasound on day 2-3, 6-8 and 10-11 of the cycle. The duration of the ultrasound exam is about 10 minutes and the measurement of the Anterior-posterior dimension of uterine corpus/endometrium thickness takes about one minute. During the transvaginal ultrasound exam endometrium thickness and uterine size will be measured. Participants undergo blood testing 10-13 days after embryo transfer to prove biochemical pregnancy and another ransvaginal ultrasound on the day 20-25 after the embryo transfer to prove clinical pregnancy.
Intervention type
Primary outcome measure	1. Endometrium thickness is measured using transvaginal ultrasound before the start of an IVF/ICSI cycle, and then on day 2-3, 5-8 and 9-11 of the IVF/ICSI cycle. 2. Uterine size is measured using transvaginal ultrasound before the start of an IVF/ICSI cycle, and then on day 2-3, 5-8 and 9-11 of the IVF/ICSI cycle
Secondary outcome measures	IVF/ICSI success rate is measured using βhCG on 10-13 day after the embryo transfer (to prove biochemical pregnancy) and transvaginal ultrasound on the day 20-25 after the embryo transfer (to prove clinical pregnancy).
Overall study start date	13/06/2016
Completion date	01/12/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	100
Key inclusion criteria	1. Women 2. Undergoing fertility treatment by stimulated IVF/ICSI, using the Antagonist Protocols 3. Transfer done on day 5 after the ovum pick up 4. Aged 20-45 years
Key exclusion criteria	1. Large or multiple fibroids 2. Uterine anomalies 3. Extremely small uterus APDUC bellow 25mm 4. BMI outside the range 19 - 29
Date of first enrolment	01/12/2016
Date of final enrolment	01/09/2017

Locations

Countries of recruitment

Bulgaria

Study participating centre

Vienna In Vitro Center

Tokuda Hospital Sofia, IX floor
Nikola Vaptzarov 51b Blvd
Lozenetz
Sofia
1407
Bulgaria

Sponsor information

Vienna In Vitro Center
Hospital/treatment centre

Tokuda Hospital Sofia, IX floor
Nikola Vaptzarov 51b Blvd
Lozenetz
Sofia
1407
Bulgaria

Funders

Funder type

Hospital/treatment centre

Vienna In Vitro Center

No information available

Results and Publications

Intention to publish date	01/12/2018
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Planned publication in a high-impact peer reviewed journal and setting the intent to publish date around one year after the overall trial end date.
IPD sharing plan	The datasets generated duringthe current study are not expected to be made available due to very personal character of the procedures and because of patient requests.