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The association of paternal factors with recurrent pregnancy loss; REMI III study

The association of paternal factors with recurrent pregnancy loss; REMI III study - REMI III study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON49845
Enrollment
270
Registered
2019-04-08
Start date
2019-06-12
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

habitual abortion Recurrent miscarriages

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Couples with unexplained recurrent pregnancy loss (defined according to the ESHRE 2017 guideline) who visit the recurrent pregnancy loss clinic in the Leiden University Medical Center (LUMC) or Erasmus Medical Center (EMC) are included.

Exclusion criteria

Exclusion criteria: Exclusion criteria are 1. Known causes for RPL(parental chromosomal abnormalities, uterine anomalies, acquired thrombophilia, thyroid autoimmunity) 2. Mentally or legally incapability 3. Pregnancy after oocyte- embryo or spermatozoa donation 4. Loss of

Design outcomes

Primary

MeasureTime frame
Primary exposure of case control study: paternal age Primary outcome of cohort study: the development of live birth within 5 years after initial visit of the recurrent miscarriage clinic

Secondary

MeasureTime frame
Secondary exposures of case control study: BMI, smoking, physical exercise, sperma apoptose, immunomodulatory factors in peripheral blood and seminal plasma (cytokines) Secondary outcomes of cohort study: development of ongoing pregnancy (>24 weeks), time interval until next pregnancy, development of pregnancy complications such as growth restriction, pre term delivery and pre eclampsia

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)