Infertility Clinical Trial
Official title:
The Efficacy of Endometrial Biopsy on the Outcome of In Vitro Fertilization (IVF) /Intra-Cytoplasmic Sperm Injection (ICSI) Treatment (Endoscratch): A Feasibility Pilot Study
This study aims to see if taking a small sample from the lining of the womb (the 'scratch')
before starting in vitro fertilization (IVF) treatment can influence the chance of getting
pregnant and having a healthy, term baby.
This study also aims to explore why an embryo is not accepted or indeed rejected by the
lining of the womb. This will be analysed by carefully looking at the sample taken from the
lining of the womb under the microscope and analysing the levels of natural killer (NK)
cells. These cells are thought to regulate the implantation process and to be altered in
some women with infertility and miscarriage.
Status | Completed |
Enrollment | 160 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 49 Years |
Eligibility |
Inclusion Criteria: - Women with history of primary or secondary infertility undergoing fresh IVF/ ICSI treatment or frozen embryo replacement cycle - Age <49 Exclusion Criteria: - Non- ovulatory cycles - Absent uterus - Uterine instrumentation within previous 3 menstrual cycles - Women in the oocyte donation program |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Nurture Fertility | Nottingham | Nottinghamshire |
Lead Sponsor | Collaborator |
---|---|
Nottingham University Hospitals NHS Trust | University Hospitals Coventry and Warwickshire NHS Trust, University of Nottingham |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Sonographic markers of endometrial receptivity | Detailed endometrial assessment will be performed using two-, three- dimensional ultrasound, as well as power and pulse-wave Doppler ultrasound imaging. Results of these measurements will be correlated with subsequent IVF/ICSI treatment outcome. | Approximately 2 years | No |
Primary | A difference in the term (37 completed weeks of gestation), singleton live birth rate in women undergoing IVF/ICSI treatment following endometrial biopsy versus control subjects. | Approximately 9 months after completion of the last procedure of the last study participant. | No | |
Secondary | A difference in the live birth rate (birth of a live baby after 24th week of gestation and before 37th completed weeks) in women undergoing IVF/ICSI treatment following endometrial biopsy versus control subjects. | Approximately 9 months after completion of the last procedure of the last study participant. | No | |
Secondary | A difference in the multiple pregnancy rate in women undergoing IVF/ICSI treatment following endometrial biopsy versus control subjects. | Approximately 9 months after completion of the last procedure of the last study participant. | No | |
Secondary | A difference in the implantation rate in women undergoing IVF/ICSI treatment following endometrial biopsy versus control subjects. | Approximately 9 months after completion of the last procedure of the last study participant. | No | |
Secondary | A difference in the biochemical pregnancy rate in women undergoing IVF/ICSI treatment following endometrial biopsy versus control subjects. | Approximately 9 months after completion of the last procedure of the last study participant. | No | |
Secondary | A difference in the clinical pregnancy rate in women undergoing IVF/ICSI treatment following endometrial biopsy versus control subjects. | Approximately 9 months after completion of the last procedure of the last study participant. | No | |
Secondary | A difference in the miscarriage rate (loss of pregnancy before viability) in women undergoing IVF/ICSI treatment following endometrial biopsy versus control subjects. | Approximately 9 months after completion of the last procedure of the last study participant. | No | |
Secondary | A difference in the ectopic pregnancy rate in women undergoing IVF/ICSI treatment following endometrial biopsy versus control subjects. | Approximately 9 months after completion of the last procedure of the last study participant. | No |
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