In this project we hypothesize that recurrent pregnancy miscarriages is an issue stemming from both the female as the male. The overall aim is to elucidate paternal factors associated with RPL (A) and to assess the predictive value of these factors…
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
Recurrent spontaneous miscarriages (RSM), or in international guidelines termed
recurrent pregnancy loss (RPL), is defined as 2 or more spontaneous
miscarriages. It affects 3% of all fertile couples and only in 50% an
underlying cause may be identified. An essential part of the management of
couples with RPL is to give trusthworthy advice on the prognosis of the next
pregnancy. The main limitation in current prognostic studies however is the
lack of adjustment for relevant risk factors, disabling the possibility of
individual risk estimation. Currently, there is hardly any focus on paternal
factors, that could potentially contribute to the development of RPL. At the
moment, male eveluation of patients with RPL only consists of a karyotype and
studies focusing on male factors in RPL are scarce.
Study objective
In this project we hypothesize that recurrent pregnancy miscarriages is an
issue stemming from both the female as the male. The overall aim is to
elucidate paternal factors associated with RPL (A) and to assess the predictive
value of these factors on a successful outcome of a next pregnancy (B).
Study design
The project will be performed as a multicenter hospital-based case-control
study (A) and retrospective and prospective cohort study of couples attending
the recurrent miscarriage unit (B).
Study burden and risks
No experimental medication will be used. Women will be treated according to
local hospital protocol, both at the recurrent miscarriage outpatient clinic
and the regular obstetric outpatient clinic. No additional risks or burden are
expected from the study, except for a one-time blood collection of
participating men (risk of discomfort, hematoma). No additional hospital visits
are required. We estimate the electronic questionnaire to be little burdensome.
For the group of patients with repeated miscarriages, some questions (about
obstetrical history) might be confrontational. Those questions are, however,
also a standard part of a consultation in the recurrent miscarriages outpatient
clinic.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
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
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL66917.058.19 |
| Other | NL7762 (Netherlands Trial Register) |