A Study to Assess if Scratching the Lining of the Womb Prior to IVF Treatment Increases the Chances of Pregnancy
The Efficacy of Endometrial Biopsy on the Outcome of In Vitro Fertilization (IVF) /Intra-Cytoplasmic Sperm Injection (ICSI) Treatment (Endoscratch): A Feasibility Pilot Study
1 other identifier
interventional
160
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 3, 2013
CompletedFirst Posted
Study publicly available on registry
June 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedNovember 22, 2016
November 1, 2016
2.3 years
June 3, 2013
November 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Secondary Outcomes (7)
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.
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.
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.
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.
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.
- +2 more secondary outcomes
Other Outcomes (1)
Sonographic markers of endometrial receptivity
Approximately 2 years
Study Arms (2)
Endometrial biopsy arm
EXPERIMENTALParticipants randomised to this arm arm will undergo an endometrial biopsy procedure using Pipelle endometrial sampler (Pipelle de Cornier, Laboratoire CCD, Paris, France) or Wallace/ Wallach endometrial sampler as an alternative device on cycle day LH+7 to LH+9 of the cycle directly preceding commencement of down-regulation prior to IVF or ICSI treatment. A transvaginal ultrasound scan will be performed prior to the biopsy.
Control group
NO INTERVENTIONParticipants randomised to control group will undergo a transvaginal ultrasound scan on day LH+7 to LH+9 of the cycle directly preceding commencement of IVF/ICSI treatment.
Interventions
Endometrial biopsy will be performed in the study group and timed according to a positive urinary LH (ovulation) kit at LH+7 to +9 days.
A detailed assessment of the endometrium will be performed including two- and three- dimensional ultrasound, as well as power Doppler acquisitions.
Eligibility Criteria
You may qualify if:
- Women with history of primary or secondary infertility undergoing fresh IVF/ ICSI treatment or frozen embryo replacement cycle
- Age \<49
You may not qualify if:
- Non- ovulatory cycles
- Absent uterus
- Uterine instrumentation within previous 3 menstrual cycles
- Women in the oocyte donation program
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nurture Fertility
Nottingham, Nottinghamshire, NG7 2UH, United Kingdom
Related Publications (1)
Lensen SF, Armstrong S, Gibreel A, Nastri CO, Raine-Fenning N, Martins WP. Endometrial injury in women undergoing in vitro fertilisation (IVF). Cochrane Database Syst Rev. 2021 Jun 10;6(6):CD009517. doi: 10.1002/14651858.CD009517.pub4.
PMID: 34110001DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nick Raine-Fenning, PhD
University of Nottingham
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 3, 2013
First Posted
June 20, 2013
Study Start
February 1, 2013
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
November 22, 2016
Record last verified: 2016-11