Couples trying to get pregnant who meet at least one of the following conditions: - Primary or secondary infertility (primary infertility is when a pregnancy has never been achieved (when tried for), and secondary infertility is when at least one prior pregnancy has been achieved) - One or more failed implantation post-embryo transfer - One or more miscarriages including biochemical pregnancy loss - Previous placenta-mediated pregnancy complications defined as pre-eclampsia, small for gestationa
Conditions
Interventions
Both partners in the couple will give a blood sample (+/- optional saliva sample) for M2 haplotype testing. The M2 haplotype, a genomic variant with four consecutive nucleotide substitutions in the AN
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women planning a pregnancy or currently pregnant 2. Women aged 18-40 years old 3. Maternal BMI (body mass index) 18.5-34.9 kg/m2 AND 4. At least one of the following: 5. Primary or secondary infertility (primary infertility is when a pregnancy has never been achieved (when tried for), and secondary infertility is when at least one prior pregnancy has been achieved) 6. One or more failed implantation post-embryo transfer 7. One or more miscarriages including biochemical pregnancy loss 8. Previous placenta-mediated pregnancy complications defined as pre-eclampsia, small for gestational age foetus (<10th centile), spontaneous preterm birth (<34 weeks) or a combination of these. 9. Male partners of eligible women* *The male partner needs to be the same partner as in previous pregnancies where a fertility/pregnancy complication occurred which deemed the woman eligible i.e. primary or secondary infertility, failed implantation post embryo transfer, previous miscarriage, previous placenta mediated pregnancy complication.
Exclusion criteria
Exclusion criteria: 1. Anti-phospholipid syndrome (APS) 2. Participation in a clinical Study of an investigational medicinal product in the last 90 days 3. Participation in any other open or blinded, placebo-controlled trials of investigational medicinal products (if currently pregnant) 4. Women found to have multiple pregnancies or who have had multiple embryos transferred in IVF (if currently pregnant) 5. Current pregnancy conceived using donor egg or sperm 6. Women who are known to be taking heroin, cocaine or other illegal substances 7. Paternity status not known for male partner 8. Female and/or male participants unwilling to give consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcome: The proportion of eligible couples (men and women) who consent to be tested measured using data recorded in study records at one timepoint | — |
Secondary
| Measure | Time frame |
|---|---|
| Preliminary estimates of sensitivity (Sn), specificity (Sp), positive predictive value (PPV), and negative predictive value (NPV) from the proportions of false positive, false negative, true positive, and true negative rates will be calculated using binomial exact methods. This will be undertaken for salivary versus blood samples for M2 gene haplotype status measured using Sanger sequencing at one timepoint | — |
Countries
England, United Kingdom
Contacts
Public ContactLaura Butler
Outcome results
None listed