RCT on the Effect of Endometrial Injury on Ongoing Pregnancy Rate in Subfertile Women Undergoing IVF

NCT01977976 | Completed DMC

• 1 other identifier: TY03
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Implantation failure remains one of the major factors limiting success in IVF treatment. It was postulated that the local injury to endometrium induces secretions of cytokines and growth factors such as leukemia inhibitory factor, interleukin-11, and heparin-binding EGF-like growth factor which enhance decidualisation and facilitate implantation. It may also up-regulate the gene expressions related to endometrial receptivity and optimize the endometrial development. In stimulated cycles, local injury to the proliferative endometrium has been postulated to delay endometrial development thereby inducing synchronicity between endometrium and embryo stage and facilitate implantation (Zhou et al, 2008; Almog et al, 2010; Gnainsky et al, 2010) The aim of the study is to determine whether endometrial injury by endometrial biopsy in mid-secretory phase of the preceding cycle would improve the on-going pregnancy rate in subfertile women undergoing IVF treatment.

Conditions

Subfertility

Keywords

Endometrial injury; Pipelle; Implantation; Ongoing pregnancy rate; IVF

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy rate

  Ongoing pregnancy rate per fresh embryo transfer

  10-12 weeks gestation

Secondary Outcomes (1)

• implantation rate

  4 weeks after embryo transfer

Other Outcomes (1)

• Clinical pregnancy rate

  4 weeks after embryo transfer

Study Arms (2)

Endometrial Aspirate (EA) group

EXPERIMENTAL

Endometrial aspirate by pipelle

Procedure: Endometrial aspiration by pipelle

Control group

NO INTERVENTION

No intervention prior to scheduled IVF

Interventions

Endometrial aspiration by pipelle PROCEDURE

Endometrial aspiration by pipelle is to be performed on LH+7 in the cycle preceding scheduled IVF treatment

Endometrial Aspirate (EA) group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Undergoing IVF for tubal, unexplained or male factor subfertility
• Normal uterine cavity as shown on saline sonogram / hysteroscopy done at baseline

You may not qualify if:

• Presence of hydrosalpinx
• Presence of endometrial polyp or fibroid distorting uterine cavity
• IVF cycles carried out for preimplantation genetic diagnosis
• Use of donor gametes

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

• Yeung TW, Chai J, Li RH, Lee VC, Ho PC, Ng EH. The effect of endometrial injury on ongoing pregnancy rate in unselected subfertile women undergoing in vitro fertilization: a randomized controlled trial. Hum Reprod. 2014 Nov;29(11):2474-81. doi: 10.1093/humrep/deu213. Epub 2014 Sep 8.

  PMID: 25205759 DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Tracy Yeung, MRCOG

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: November 7, 2013
• Study Start: April 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: April 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

HK (1)