This study is conducted to discover if bacterial vaginosis is related to the pregnancy rate in couples undergoing assisted reproduction.
ID
Source
Brief title
Condition
- Bacterial infectious disorders
- Abortions and stillbirth
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Ongoing pregnancy rate at 12 weeks
Secondary outcome
1. Biochemical pregnancy
2. Clinical pregnancy rate as defined by ultrasound with fetal heartbeat at
7-weeks gestation
3. Ectopic pregnancy rate
4. Live birth rate
5. Attempts (ET/IUI) until pregnant
6. Preterm delivery (<37 weeks)
Background summary
Bacterial vaginosis is defined as a dysbiosis of the vaginal microbiome.
Bacterial vaginosis (BV) is known to influence some obstetric outcomes, such as
preterm delivery. Only few studies investigated the effect of BV on pregnancy
among subfertile women, and a few found a negative effect on fecundity.
Study objective
This study is conducted to discover if bacterial vaginosis is related to the
pregnancy rate in couples undergoing assisted reproduction.
Study design
This will be a prospective cohort study, patients starting with fertility
treatment will be included.
Before starting the treatment a PCR-swab and pH measurement of the vagina will
be done, to assess the vaginal flora. Groups will be divided in BV positive and
negative.
At time of insemination/oocyte collection a second swab will be done. Pregnancy
outcomes are monitored, also when it becomes a miscarriage. If patients are not
pregnant or having a miscarriage after the first treatment, a swab will be done
at every insemination/oocyte collection/embryo transfer until the patient is
pregnant. All patients have a blood hcg test two weeks after insemination or
embryo transfer to confirm pregnancy.
Duration of this study is two years, with a follow-up period until live birth.
After inclusion information about the medical history, fertility treatment
(months/cycles of treatment until pregnancy) and relevant information about the
pregnancy will be collected (miscarriage, preterm delivery, live birth).
When participating patients are symptomatic for BV they will be treated with
clindamycin. After treatment a second swab will be done to assess vaginal flora
at the next doctors appointment. This subgroup of symptomatic patients will be
analysed within the study as well as separately.
Data will be collected in the data management system Castor. Data will be
collected by the investigator van den Tweel or a research student.
Study burden and risks
not applicable
Bronovolaan 5
Den Haag 2597 AX
NL
Bronovolaan 5
Den Haag 2597 AX
NL
Listed location countries
Age
Inclusion criteria
Patients who undergo fertility treatment, IVF/ICSI or IUI.
Exclusion criteria
three miscarriages or more in history
prophylactic antibiotic use
not able to understand English or Dutch
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 | NL63452.098.18 |