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Implantation failure as a cause of unexplained infertility; determinants of the successrate in ART in women with unexplained infertility.

Implantation failure as a cause of unexplained infertility; determinants of the successrate in ART in women with unexplained infertility. - Embryo implantation and unexplained infertility

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON29894
Enrollment
140
Registered
2006-07-18
Start date
2006-08-14
Completion date
Unknown
Last updated
2024-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

idiopathic subfertility unexplained infertility

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)