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NCT Number: NCT01977976

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

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.

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Key information

Conditions

Subfertility Genital Diseases Infertility Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Hong Kong

Hong Kong

About this study

Consecutive women attending subfertility clinic at Queen Mary Hospital, University of Hong Kong who are scheduled for IVF treatment will be recruited. Women who have normal uterine cavity will be randomized into study and control groups in 1 to 1 ratio according to a computer-generated randomization list. Patients will be stratified according to the first or repeated cycle.

For patients in the study group, in the cycle immediately preceding the scheduled IVF treatment, LH surge will be determined by daily serum LH level starting from 18 days before the next expected period. LH surge is defined as an elevation of LH to 2 times the level of the average of the previous 3 days and the absolute level of the LH should be more than or equal to 20 IU/L. Women randomized into the study group will have endometrial biopsy performed by pipelle 7 days after the LH surge (LH+7) and they will be instructed to use non-hormonal means of contraception during that cycle. All patients will then proceed to IVF treatment in the next cycle as scheduled. They will receive standard ovarian stimulation according to the departmental protocol and have a maximum of two embryos replaced 2 days after the oocyte retrieval. On-going pregnancy rates between the two groups will be compared.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Endometrial aspiration by pipelle

Procedure

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

Primary outcomes

  1. Ongoing pregnancy rate

    Time frame: 10-12 weeks gestation

    Ongoing pregnancy rate per fresh embryo transfer

Secondary outcomes

  1. implantation rate

    Time frame: 4 weeks after embryo transfer

    number of gestation sac on pelvic scan per number of embryo transferred

Other outcomes

  1. Clinical pregnancy rate

    Time frame: 4 weeks after embryo transfer

    Presence of at least one fetal heart pulsation per fresh embryo transfer 4 weeks after transfer

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

A Randomized Controlled Trial on the Effect of Endometrial Injury on Improving Ongoing Pregnancy Rate in Subfertile Women Undergoing in Vitro Fertilization Treatment

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Nov 7, 2013
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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