The association of paternal factors with recurrent pregnancy loss

• Conditions: Recurrent Pregnancy Loss

• Registration Number: NL-OMON20082
• Lead Sponsor: eiden University Medical Center / Leiden University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 88

Inclusion Criteria

Cases: Unexplained recurrent pregnancy loss (according to ESHRE guideline RPL 2017)

Controls: = 1 spontaneous miscarriage, proven fertility (i.e. pregnant at inclusion or previously experienced pregnancy in same relationship)

Exclusion Criteria

Cases: 1) known causes for RPL (parental chromosomal chromosomal abnormalities, uterine anomalies, acquired or hereditary thrombophilia, hyperhomocystenaemia and untreated or instable endocrine disease); 2) mentally or legally incapibility of either male or female; 3) treatment with oocyte, embryo or spermatozoa donation; 4) loss of < 2 pregnancies in current relationship

Controls: 1) any known cause for RPL as described above; 2) mentally or legally incapibility of either male or female; 3) treatment with oocyte, embryo or spermatozoa donation

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Case-control study: paternal age<br>Cohort study: development of live birth within 5 years after initial consultation

Secondary Outcome Measures

Name	Time	Method
Case-control study: BMI, smoking, alcohol consumption, recreational drug consumption, physical exercise, sperm DNA fragmentation level, immunomodulatory factors in blood and seminal fluid <br>Cohort study: Development of ongoing pregnancy (>24 weeks), time interval until next pregnancy, development of pregnancy complications such as growth restriction, preterm delivery and preeclampsia