Condition category
Pregnancy and Childbirth
Date applied
18/10/2016
Date assigned
21/11/2016
Last edited
07/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Public

Primary contact

Dr Georgi Stanulov

ORCID ID

http://orcid.org/0000-0002-8704-1555

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

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

Acronym

Study hypothesis

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

The study was approved by the Ethic committee of MBAL "Tokuda" Sofia Bulgaria

Study design

Prospective cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

13/06/2016

Overall trial end date

01/12/2017

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

100

Participant exclusion criteria

1. Large or multiple fibroids
2. Uterine anomalies
3. Extremely small uterus APDUC bellow 25mm
4. BMI outside the range 19 - 29

Recruitment start date

01/12/2016

Recruitment end date

01/09/2017

Locations

Countries of recruitment

Bulgaria

Trial participating centre

Vienna In Vitro Center
Tokuda Hospital Sofia, IX floor Nikola Vaptzarov 51b Blvd Lozenetz
Sofia
1407
Bulgaria

Sponsor information

Organisation

Vienna In Vitro Center

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Vienna In Vitro Center

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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.

Intention to publish date

01/12/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes