We will assess the correlation between the incidence of early pregnancy loss and the successrate of ART in women with unexplained infertility. We will also investigate the difference in the incidence of early pregnancy loss in women with unexplained…
ID
Source
Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are:
• ßHCG levels in urine
• Cytokine expression in endometrial secretion/ culture
The main study endpoint is:
• Cumulative pregnancy rate
• Early pregnancy loss rate
• The embryo secretion cytokine expression profile
• The endometrial secretion cytokine expression profile before embryo transfer.
Secondary outcome
The secondary study parameters are:
• Lifestyle factors: physical exercise, smoking, use of caffeine and alcohol,
BMI (body mass index)
• uNK cell count, endometritis
• PI van de a uterina before ET
The secondary study endpoints are:
• Correlation between secondary study parameters and diagnosis of unexplained
infertility
• Early pregnancy loss rate
Background summary
Subfertility is defined as failure to conceive a clinical pregnancy after 1
year of unprotected intercourse. In up to 30% of couples presenting with
subfertility, no cause is found on routine infertility investigation (Hull et
al., 1985). Current standard investigation is limited to analysis of ovarian
ovulatory function, patency of the fallopian tubes, semen quality and in some
centres, quality of cervical mucous-sperm interaction. The possible role of
abnormalities in endometrial receptivity and implantation as underlying causes
of subfertility continue to be largely ignored, partly due to the absence of
appropriate tests and effective interventions.
Study objective
We will assess the correlation between the incidence of early pregnancy loss
and the successrate of ART in women with unexplained infertility. We will also
investigate the difference in the incidence of early pregnancy loss in women
with unexplained infertility versus normal fertile women.
Additionally, the endometrial cytokine expression profile in women with
unexplained infertility versus a reference groep of women undergoing ICSI (male
factor) who achieved a pregnancy during study 05-225K, will be studied.
Study design
The study design is a prospective, mono-centre, case-control study.
Study burden and risks
Women with unexplained infertility will collect urine samples during the time
on the waiting list to detect an early pregnancy loss. Since most women are
curious to know whether an early pregnancy has occurred, we do not expect the
burden to be to high. Fertile women will also collect urine samples for three
months (from cycle day 14 onwards).
The theoretical risk associated with the aspiration of endometrial secretion
before embryo transfer might be disruption of embryo implantation. However, our
group has developed a technique which, as we have previously shown, does not
disrupt the process of implantation (van der Gaast et al., 2003).
Heidelberglaan 100
3584 CX Utrecht
Nederland
Heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
Study group
• Women with unexplained infertility after routine fertility and PEPSI screening.
• Women who will start their first IVF treatment cycle. ;Definition unexplained infertility:
• There must be a regular cycle (between 21-42 days),
• normal semen analysis (VCM > 10 million, normal morpholohy > 14%),
• no tubal factor (no abnormalities on hysterosalpingografy and negative CAT) and
• no abnormlaities on the hysteroscopy (partial septum, submucosal/Intramural fibroids, endometrial polyps, adhesions, chronic and acute endometritis: diagnosed by the pathologist)
• no abnormalities from blood screening: FSH < 10, no anticardiolipin antibodies/ lupus anticoagulant/ Factor V Leiden mutation/ prothrombin gene mutation/ deficiencies in protein S/ protein C and antithrombin, no abnormal TSH. ;Reference group normal implanters (only data will be used)
• Women who have conceived after ICSI treatment for male factor infertility.
• Women who were included in study 05/225-K.;Reference group normal fertile women
• Women who have never showed any fertility disorders (preferably already conceived and delivered).
Exclusion criteria
Study group
• PESA (percutaneous epididymal sperm aspiration) / MESA (microsurgical epididymal sperm aspiration / TESE (testicular sperm extraction)
• Difficulty in communicating in Dutch or English
• Women older than 37 years;Reference group of normal fertile women
• Women older than 37 years
• Women who have already tried to conceive for more than four months/ who have had any fertility disorders in the past.;Exclusion criteria for endometrial secretion aspiration:
• Excisional procedures to treat cervical intraepithelial neoplasia and no previous uncomplicated ET/IUI.
• Previous ducumented difficult intra uterine inseminations
Design
Recruitment
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 |
|---|---|
| Other | Na goedkeuring METC zal de trial geregistreerd worden bij clinicaltrials.gov. |
| CCMO | NL12321.041.06 |