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

Recruiting
Conditions
habitual abortion
Recurrent miscarriages
10010273
Registration Number
NL-OMON49845
Lead Sponsor
eids Universitair Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
270
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 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 < 2 pregnancies in current relationship

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Primary exposure of case control study: paternal age<br /><br><br /><br>Primary outcome of cohort study: the development of live birth within 5 years<br /><br>after initial visit of the recurrent miscarriage clinic</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary exposures of case control study: BMI, smoking, physical exercise,<br /><br>sperma apoptose, immunomodulatory factors in peripheral blood and seminal<br /><br>plasma (cytokines)<br /><br><br /><br>Secondary outcomes of cohort study: development of ongoing pregnancy (>24<br /><br>weeks), time interval until next pregnancy, development of pregnancy<br /><br>complications such as growth restriction, pre term delivery and pre eclampsia</p><br>
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