Posted by on Jun 29, 2015 in Infertility | 0 comments

In a nutshell

This trial aims to evaluate the impact of Comprehensive Chromosome Screening (CCS) on patients with low ovarian reserve (the ovaries have a reduced capacity to provide eggs that are capable of fertilization), in an effort to improve success during in vitro fertilization (IVF) and decrease the time to successful pregnancy. The main outcome to be measured is delivery (live birth) rate.

The details

Aneuploidy is the term used to describe an embryo with either too many or too few chromosomes. CCS is a technology that can screen embryos in advance to make sure that they have the correct number of chromosomes. This may increase implantation rates in IVF and reduce the rates of pregnancy loss.

This study will measure the delivery rate after CCS. 

Who are they looking for?

This study will recruit around 400 women (less than 43 years of age) with low ovarian reserve, and their male partners. Women must have anti-müllerian hormone levels (used to determine the quantity of eggs remaining in the ovary) less than 1.1 or basal antral follicle count (measures remaining egg supply) less than 8 in the previous year to be classed as having low ovarian reserve. The male partner must have more than 100,000 motile sperm and a body mass index (measurement based on height and weight) less than 32.

Patients cannot take part if they have endometrial insufficiency (thin womb lining), use of egg donors or gestational carriers (surrogacy). Other exclusion criteria include: use of surgical sperm retrieval techniques, single gene disorders, and participation in another study.

How will it work

Participants will be divided into 2 groups. The study group, which will receive CCS, and the control group, which will not receive CCS.

Patients will undergo a stimulated IVF cycle, during which eggs will be retrieved. Once embryos reach blastocyst stage (about 5 days after fertilization) patients will be randomly allocated to one of the two study groups. The patients and study staff will be blinded, which mean that neither will know to which group the embryos were assigned. 

Clinical trial locations

Locations near 43201, United States (Change):
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Type:Interventional
Participants:400
Study ID:NCT01977144
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