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.
Following consent, participants will be randomised to one of the two trial interventions
(endometrial biopsy, or ultrasound scan only = no intervention) by a member of the research
team. The procedures will be scheduled for luteinising hormone (LH) day +7 to +9 of the
menstrual cycle directly preceding commencement of down-regulation medications. A urine
pregnancy test will be performed before the studied procedure. Just prior to the biopsy and
directly following it, a transvaginal ultrasound scan will be performed to assess the length
of the uterine cavity and endometrial parameters, including blood flow characteristics using
power Doppler imaging. Endometrial sample will be obtained using standard sampling procedure
by appropriately trained clinician.
Participants randomised to treatment 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. The
endometrial sampling will be repeated a maximum of four times (all during the same
appointment on day LH+7 to LH+9 of menstrual cycle) to assure a sufficient sample is
obtained. If following the first two attempts, the endometrial sample is sufficient,
procedure will be deemed complete. The Pipelle sampler will be introduced up to the uterine
fundus (based on clinical touch technique and ultrasound measurements), and attempts will be
made to obtain samples from all four walls of the endometrial cavity.
Participants randomised to control group will also be supplied with home LH testing kits
after informing the unit of the will to participate. Once the ovulation test is positive,
the participant will contact the unit to arrange the ultrasound appointment on day LH+7 to
LH+9 of the cycle directly preceding commencement of IVF/ICSI treatment. 48 to 72 hours
later and additional appointment will be scheduled for ultrasound scan and blood tests.
Subjects will then be randomised to one of the two treatment arms based on a computer
generated pseudo-random code using random permuted blocks of randomly varying size, created
by the University of Nottingham Clinical Trials Unit (CTU). As a pilot feasibility study,
the randomisation will not be stratified by any factors. Allocation to treatments will be in
the ratio 1:1. The corresponding treatment allocation will be transmitted to the unblinded
clinician, who will arrange the appropriate appointments for study procedures.
Due to the nature of the study, no blinding of participant or researchers is possible.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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