Effect of Endometrial Biopsy on in Vitro Fertilization Pregnancy Rates - a Multicenter Study (EndoBx-IVF)
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|ClinicalTrials.gov Identifier: NCT01983423|
Recruitment Status : Terminated (Suboptimal subject recruitment)
First Posted : November 14, 2013
Last Update Posted : November 28, 2017
Animal and clinical studies have suggested that local tissue trauma can promote the process of an embryo implanting in the uterine cavity. The clinical studies have been performed in patients with a history of previously failed treatments using in vitro fertilization; a process of stimulating many eggs from a women and removing them from the body, to allow fertilisation with sperm to occur in a laboratory setting. The embryos are then replaced into the uterine cavity.
This study questions whether endometrial biopsy (placing a small straw like catheter through the cervix and into the uterine cavity to take a sample of tissue via suction into the bore of the catheter), within 5-10 days of starting a cycle of in vitro fertilization, will improve pregnancy outcome for patients in the first or second cycle of treatment. The hypothesis is that endometrial biopsy will improve pregnancy outcome.
The study is a randomized multicentre study involving 3 Canadian fertility centres.
|Condition or disease||Intervention/treatment||Phase|
|Infertility Pregnancy||Device: Endometrial Biopsy||Not Applicable|
Although the data are preliminary, there are studies suggesting that mild endometrial trauma in the cycle preceding IVF increases pregnancy rates, at least in women with recurrent implantation failure. Whether endometrial biopsy could promote implantation and improve pregnancy rates in the larger population of women undergoing IVF has yet to be explored. The present study will address this question and examine the impact of endometrial biopsies on IVF outcomes in the context of a randomized controlled trial.
The optimal timing of the endometrial biopsy in the cycle preceding IVF has not been determined, but the majority of the studies have included a biopsy in the mid-luteal phase of the preceding cycle. In order to allow an adjuvant therapy to IVF that would be considered tolerable to a subject, and applicable to a large infertile women population, it was determined that a single endometrial biopsy, performed approximately 1 week prior to the start of controlled ovarian hyperstimulation (COH) in an IVF cycle, would be the simplest, most flexible, and generalizable intervention to study its effects on pregnancy rates. All other components of the IVF treatment will remain constant with approximately 8-12 days of ovarian stimulation, human chorionic gonadotrophin (HCG) trigger being administered in that time frame and oocyte retrieval occuring 36 hours later from trigger. The embryo transfer will take place either day 3 or day 5 after oocyte retrieval.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||52 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Endometrial Biopsy on in Vitro Fertilization Pregnancy Rates - a Randomized, Multicenter Study|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||April 2016|
Experimental: Endometrial Biopsy
Endometrial biopsy performed within 5-10 days prior to starting controlled ovarian stimulation, as part of in vitro fertilization treatment.
Device: Endometrial Biopsy
An endometrial biopsy is performed using a sampling device known as a pipelle catheter which is introduced into the uterine cavity. The inner core is withdrawn creating suctional pressure into the hollow bore of the cavity, which allows acquisition of endometrial tissue upon rotation in the cavity. This is removed and the tissue sent for pathologic examination.
No Intervention: Without Biopsy
Those proceeding with in vitro fertilization routinely, without an endometrial biopsy.
- Clinical Pregnancy Rate [ Time Frame: Five weeks gestation, as dated from the egg retrieval ]Clinical pregnancy rate, defined as transvaginal ultrasound documentation of fetal heartbeat at five weeks gestation.
- Implantation Rate [ Time Frame: Five weeks gestation, as dated from the egg retrieval ]The number of gestational sacs seen at ultrasound, divided by the total number of embryos transferred
- Live Birth Delivery Rate [ Time Frame: Within twelve months of the cycle start date ]Live birth delivery rate will be the number of live birth deliveries expressed per 100 initiated cycles, aspiration cycles or embryo transfer cycles, for which the denominator (initiated, aspirated or embryo transfer cycles) will be specified. Live birth delivery will include deliveries that resulted in at least one live birth. The delivery of a singleton, twin or other multiple births will be registered as one delivery.
- Fertilization Rate [ Time Frame: 24 hours after egg retrieval ]Fertilization rate will be the number of zygotes resulting from insemination by IVF or injection by intracytoplasmic sperm injection, expressed as a ratio to the total number of oocytes inseminated or injected.
- Normal Fertilization Rate [ Time Frame: 24 Hours from egg retrieval ]Normal fertilization rate will be the number of normal zygotes resulting from insemination by IVF or injection by ICSI, expressed as a ratio to the total number of oocytes inseminated or injected.
- Endometrial Thickness [ Time Frame: Day of administration of human chorionic gonadotropin (8-12 days into ovarian stimulation) ]As assessed by transvaginal ultrasound, the maximum dimension of the endometrial cavity echo in an antero-posterior plane.
- Endometrial Pattern [ Time Frame: Day of administration of human chorionic gonadotropin (8-12 days into ovarian stimulation) ]The endometrial pattern will be categorised as either trilaminar (triple stipe pattern) or hyperechoic (diffusely echogenic)at the time of transvaginal ultrasound assessment.
- Percentage of subjects with embryos cryopreserved [ Time Frame: At the latest, day 6 after egg retrieval ]Total number of participants with embryos in excess, that met criteria for cryopreservation
- The number of embryos cryopreserved per subject [ Time Frame: At the latest, day 6 after egg retrieval ]The number of embryos each individual participant had in excess, meeting criteria for cryopreservation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01983423
|Canada, British Columbia|
|Pacific Centre for Reproductive Medicine|
|Vancouver, British Columbia, Canada, V5G 4X7|
|Mt. Sinai Hospital Centre for Fertility and Reproductive Health|
|Toronto, Ontario, Canada, M5T 2Z5|
|Principal Investigator:||Jon C Havelock, MD||Pacific Centre for Reproductive Medicine and University of British Columbia|