MedPath

Het MURIM onderzoek

Conditions
Repeated implantation failure, repeated miscarriage
Registration Number
NL-OMON24778
Lead Sponsor
Maastricht University Medical Centre (azM)
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
249
Inclusion Criteria

Repeated implantation failure:
•Female aged 18-38 years old
o the absence of implantation after two consecutive cycles of IVF or ICSI, or frozen embryo transfer cycles,
owhere the cumulative number of transferred embryo’s was no less than 4 cleavage stage embryo’s or no less than 2 for blastocysts
•Primary or secondary infertility
•Written informed consent

Recurrent miscarriages
•Female aged 18-38 years old
•Repeated, unexplained miscarriages (RM) defined as 2 or more unexplained miscarriages not caused by abnormal parental karyotype, maternal thrombophilia and/or uterine abnormalities
•Written informed consent

Control
•Female aged 18-38 years old
•Uneventful previous pregnancy (minimal 1 child) defined as no preterm delivery, pre-eclampsia or fetal growth restriction, and live birth or presumed fertility
•Written informed consent

Exclusion Criteria

Repeated implantation failure
•Clinically relevant intra-uterine pathology
•BMI > 35 kg/m2
•Untreated endocrine abnormalities
•PGD treatment
•Severe endometriosis (3th -4th degree)

Recurrent miscarriages
•Current or recent (<3 months ago) pregnancy, breastfeeding or hormonal contraceptive
•Current symptomatic genital infection
•BMI > 35 kg/m2
•Severe endometriosis (3th -4th degree)

Control group
•Previous miscarriages or implantation failure
•Current or recent (<3 months ago) pregnancy, breastfeeding or current hormonal contraceptive use
•BMI > 35 kg/m2
•Severe endometriosis (3th -4th degree)

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The main study parameters are steroid profile in endometrial tissue and serum, activity of steroid enzymes, percentage of natural killer (NK) cells with an activating phenotype, determination of the vaginal microbiome using the inter spacer bacterial profiling (ISpro) technique and volatile organic compounds.
Secondary Outcome Measures
NameTimeMethod
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