Effect of Endometrial Biopsy on in Vitro Fertilization Pregnancy Rates - a Multicenter Study

NCT01983423 | Terminated DMC

• 1 other identifier: EndoBx- IVF
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Infertility; Pregnancy

Keywords

Endometrial Biopsy; Endometrial Sampling; In Vitro Fertilization; Pregnancy; Implantation

Outcome Measures

Primary Outcomes (1)

• Clinical Pregnancy Rate

  Clinical pregnancy rate, defined as transvaginal ultrasound documentation of fetal heartbeat at five weeks gestation.

  Five weeks gestation, as dated from the egg retrieval

Secondary Outcomes (8)

• Implantation Rate

  Five weeks gestation, as dated from the egg retrieval

• Live Birth Delivery Rate

  Within twelve months of the cycle start date

• Fertilization Rate

  24 hours after egg retrieval

• Normal Fertilization Rate

  24 Hours from egg retrieval

• Endometrial Thickness

  Day of administration of human chorionic gonadotropin (8-12 days into ovarian stimulation)

Study Arms (2)

Endometrial Biopsy

EXPERIMENTAL

Endometrial biopsy performed within 5-10 days prior to starting controlled ovarian stimulation, as part of in vitro fertilization treatment.

Device: Endometrial Biopsy

Without Biopsy

NO INTERVENTION

Those proceeding with in vitro fertilization routinely, without an endometrial biopsy.

Interventions

Endometrial Biopsy DEVICE

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.

Also known as: Endometrial pipelle biopsy, Endometrial sampling

Endometrial Biopsy

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women undergoing first or second IVF cycle, with or without ICSI
• Age 18-39
• BMI 18-35 kg/m2
• Uterine cavity evaluation (hysterosalpingogram, sonohysterogram, hysteroscopy) in the preceding 24 months
• Early follicular phase (Day 2 or Day 3) serum FSH, evaluated in the preceding 6 months
• ONE of the following:
• Non- oral contraceptive pill (non-OCP) subjects: Documented LH surge 9-11 days prior to enrollment
• Current OCP subjects: OCP use for ≥ 10 days
• Use of long GnRH agonist or GnRH antagonist protocol
• Subject able to give informed consent

You may not qualify if:

• Prior enrolment in this study
• Any prior early follicular phase serum FSH level ≥12 IU/L
• Previous poor ovarian response, defined as prior IVF cycle cancelled for poor response, or ≤4 oocytes retrieved
• IVF for pre-implantation genetic diagnosis (PGD) or fertility preservation
• Diabetes mellitus or uncontrolled thyroid disease
• Abnormal uterine cavity, such as unresected submucosal fibroids, uterine septum, Mullerian anomaly such as bicornuate or unicornuate uterus or intrauterine adhesions
• Hydrosalpinx that has not been removed or surgically ligated
• Any contraindication to endometrial biopsy
• Office hysteroscopy or other uterine procedure planned or performed during cycle preceding IVF stimulation
• Use of surgically retrieved sperm

Sponsors & Collaborators

• Jon Havelock: lead

Study Sites (2)

Pacific Centre for Reproductive Medicine

Vancouver, British Columbia, V5G 4X7, Canada

Location

Mt. Sinai Hospital Centre for Fertility and Reproductive Health

Toronto, Ontario, M5T 2Z5, Canada

Location

Related Publications (10)

• Lejeune B, Lecocq R, Lamy F, Leroy F. Changes in the pattern of endometrial protein synthesis during decidualization in the rat. J Reprod Fertil. 1982 Nov;66(2):519-23. doi: 10.1530/jrf.0.0660519.

  PMID: 7175806 BACKGROUND

• Humphrey KW. The effects of some anti-oestrogens on the deciduoma reaction and delayed implantation in the mouse. J Reprod Fertil. 1968 Jul;16(2):201-9. doi: 10.1530/jrf.0.0160201. No abstract available.

  PMID: 4298258 BACKGROUND

• Gnainsky Y, Granot I, Aldo PB, Barash A, Or Y, Schechtman E, Mor G, Dekel N. Local injury of the endometrium induces an inflammatory response that promotes successful implantation. Fertil Steril. 2010 Nov;94(6):2030-6. doi: 10.1016/j.fertnstert.2010.02.022. Epub 2010 Mar 24.

  PMID: 20338560 BACKGROUND

• Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.

  PMID: 12798877 BACKGROUND

• Raziel A, Schachter M, Strassburger D, Bern O, Ron-El R, Friedler S. Favorable influence of local injury to the endometrium in intracytoplasmic sperm injection patients with high-order implantation failure. Fertil Steril. 2007 Jan;87(1):198-201. doi: 10.1016/j.fertnstert.2006.05.062.

  PMID: 17197286 BACKGROUND

• Karimzadeh MA, Ayazi Rozbahani M, Tabibnejad N. Endometrial local injury improves the pregnancy rate among recurrent implantation failure patients undergoing in vitro fertilisation/intra cytoplasmic sperm injection: a randomised clinical trial. Aust N Z J Obstet Gynaecol. 2009 Dec;49(6):677-80. doi: 10.1111/j.1479-828X.2009.01076.x.

  PMID: 20070722 BACKGROUND

• Zhou L, Li R, Wang R, Huang HX, Zhong K. Local injury to the endometrium in controlled ovarian hyperstimulation cycles improves implantation rates. Fertil Steril. 2008 May;89(5):1166-1176. doi: 10.1016/j.fertnstert.2007.05.064. Epub 2007 Aug 6.

  PMID: 17681303 BACKGROUND

• Karimzade MA, Oskouian H, Ahmadi S, Oskouian L. Local injury to the endometrium on the day of oocyte retrieval has a negative impact on implantation in assisted reproductive cycles: a randomized controlled trial. Arch Gynecol Obstet. 2010 Mar;281(3):499-503. doi: 10.1007/s00404-009-1166-1. Epub 2009 Jul 1.

  PMID: 19568761 BACKGROUND

• Katz VL. Diagnostic procedures. Imaging, endometrial sampling, endoscopy: indications and contraindications, complications. In: Katz VL, Lentz GM, Lobo RA, Gershenson DM, eds. Comprehensive Gynecology . 5th ed. Philadelphia, Pa: Mosby; 2007.

  BACKGROUND

• Hilton J, Liu KE, Laskin CA, Havelock J. Effect of endometrial injury on in vitro fertilization pregnancy rates: a randomized, multicentre study. Arch Gynecol Obstet. 2019 Apr;299(4):1159-1164. doi: 10.1007/s00404-019-05044-9. Epub 2019 Jan 19.

  PMID: 30661093 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Jon C Havelock, MD

  Pacific Centre for Reproductive Medicine and University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 12, 2013
• First Posted: November 14, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: April 1, 2016
• Last Updated: November 28, 2017

Record last verified: 2017-11

Locations

CA (2)