No registrations found.
ID
Source
Brief title
Health condition
Repeated implantation failure, repeated miscarriage
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
N/A
Background summary
Women with recurrent unexplained miscarriage (RM) and repeated implantation failure (RIF) are proposed to be at opposite ends of the implantation spectrum, with too receptive endometrium (implantation of genetically aberrant or poor quality embryos) versus too selective endometrium (no implantation even with genetically normal or good quality embryos). In both cases, no explanation for unsuccessful implantation has been found yet. Therefore, doctors can provide no therapeutic options other than supportive care on the way to a subsequent pregnancy.
The goal of this study is to elucidate whether there is a difference in endometrial parameters (determining endometrial receptivity) between women with reproductive failure: RIF and RM. Secondly we will investigate how the endometrial parameters of the women with RIF and unexplained RM compare with those of healthy, parous women to construct a receptivity profile for these women.
Study objective
We hypothesize there is a difference in endometrial parameters (determining endometrial receptivity) between women with reproductive failure: RIF and RM and healthy, parous women
Study design
n/a
Linda Stevens Brentjens
+31(0)43-3875368
linda.brentjens@mumc.nl
Linda Stevens Brentjens
+31(0)43-3875368
linda.brentjens@mumc.nl
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,
o where 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)
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7571 |
| CCMO | NL66835.068.18 |
| OMON | NL-OMON56176 |