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Register:	ISRCTN
Last refreshed on:	19 December 2016
Main ID:	ISRCTN19411490
Date of registration:	21/11/2016
Prospective Registration:	Yes
Primary sponsor:	Vienna In Vitro Center
Public title:	Establishment of new index for prediction of the implantation success rate, combining the endometrial thickness, the size of the uterus and their ratio
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
Date of first enrolment:	01/12/2016
Target sample size:	100
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN19411490
Study type:	Observational
Study design:	Prospective cohort study (Diagnostic)
Phase:

Countries of recruitment
Bulgaria

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Georgi Stanulov
Address:	Tokuda Hospital Sofia, IX floor Nikola Vaptzarov 51b Blvd Lozenetz 1407 Sofia Bulgaria
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Sterility treatment
Pregnancy and Childbirth
Sterility treatment

Intervention(s)

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.

Primary Outcome(s)

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(s)

IVF/ICSI success rate is measured using ßhCG 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).

Secondary ID(s)

Source(s) of Monetary Support

Vienna In Vitro Center

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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