An observational study in Infertility, sponsored by IVI Murcia. Status unknown at 1 site in Spain. Open to participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2018-02-19.
Sponsored by IVI Murcia · Observational
Infertility or infertility affects about 15% of couples of reproductive age. It is estimated that 80 million people around the world suffer from this problem. Assisted reproduction techniques (ART) use culture media (during in vitro fertilization or early embryo development) with protein sources that are very different from natural sources. This media could produce an added stress to the gametes and embryos that could cause epigenetic alterations and health effects during adult life.
Our working hypothesis is based on studies in animal models (pig and cow), in which it was observed that the culture media with reproductive fluids used as additives instead of conventional sources of proteins (such as serum albumin) , produce embryos with an epigenetic profile closer to that of embryos generated in the maternal oviduct. Moreover, with these fluids, blastocysts obtained have a greater number of cells and hatchability than those produced with serum albumin alone.
Therefore, the University of Murcia, with an extensive experience in this area, and the IVI Murcia (Valencian Infertility Institute) research team have come together to launch this research project in order to determine the advantages of the use of human reproductive fluids as additives in embryonic culture media. To do this, 2 specific objectives are proposed,:
This achievement would allow us the development of protocols in the nearest ART physiological conditions which represent not only a technical challenge but a biomedical responsibility that must be addressed to prevent future diseases of the offspring.
Couples undergoing assited Reproduction Treatment in IVI Murcia will be asked for their inclusion in this study. Uterine fluid will be take 48 hours after peak of LH (luteinizing hormone), in natural cycle. Oocytes from these patients, will be divided into two groups: Half of the zygotes of each patient, control group, will be grown in the conditions usually used in the clinic, and the other half, experimental group, will add 1-5% of uterine fluid from the patient (v / v)
On day 3 and on day 5 of culture the quality of the embryos in both groups will be assessed according to the usual criteria of the clinic and the best quality and highest probability of implantation will be transferred, following the usual clinical practice. The samples of uterine fluid, after the initial processing in the IVI-Murcia clinic will be transferred to the Department of Physiology of the University of Murcia where they will be fractionated to perform a quality control according to the following specifications:
Uterine fluid pH 7.0-7.6 Osmolarity (mOsm / kg) 260-320 Endotoxin (EU / mL) \<0.15 Sterility No growth
Only samples that meet these criteria will continue to be part of the study
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's planned enrollment of 27 is below the median of 200 across 592 observational studies indexed under Infertility.
Browse Infertility studies →IVI Murcia is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
infertility couples
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Woman:
between 17 and 30.Under controlled ovarian stimulation and at least 8 metaphase II oocytes collected
Man:
Sperm concentration higher than 5 million sperm / ml
Exclusion Criteria:
Diagnosis of endometriosis Uterine pathology that compromises embryonic development Patients undergoing treatment for repeat abortion or implantation failures Abnormal karyotype Patients included in the Pre-Implantation Genetic Diagnosis (DPI) program
Male:
Men whit abnormal karyotype, High values of DNA fragmentation Abnormal FISH (Fluorescence in situ Hybridization) Sperm from epididymal aspirate or testicular
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
embryo quality
Number of embryo with A or B quality according to ASEBIR (Spanish association for the study of the biology of reproduction) criteria
Time frame: embryo quality will be analyze on day 3 and 5 after fertilization
Pregnancy rate
serum levels of chorionic gonadotropin Beta (Beta-hCG)
Time frame: between 14-16 days after fertilization
ongoing pregnancy
ultrasonography
Time frame: 16-18 week after fertilization
implantation rate
number of embryos implanted/number of embryos transferred x100
Time frame: 24 days after fertilization
pregnancy loss rate
number of miscarriages/ number of ongoing pregnancy x100
Time frame: 10 days after B-hCG evaluation at end of pregnancy
Plan to share: No
Started Jan 2018 (actual). Primary completion is estimated for Oct 2019, 21 months after the start.
Of 209 non-industry observational studies under Infertility, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 100. This study's planned 21 months is below that.
Counting every sponsor, half of 242 studies reached it within 39 months; a quarter within 16 and three quarters within 100.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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