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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01977976
Enrollment
300
Registered
2013-11-07
Start date
2011-04-30
Completion date
2014-04-30
Last updated
2014-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subfertility

Keywords

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

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.

Detailed description

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.

Interventions

PROCEDUREEndometrial aspiration by pipelle

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

Sponsors

The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Ongoing pregnancy rate10-12 weeks gestationOngoing pregnancy rate per fresh embryo transfer

Secondary

MeasureTime frameDescription
implantation rate4 weeks after embryo transfernumber of gestation sac on pelvic scan per number of embryo transferred

Other

MeasureTime frameDescription
Clinical pregnancy rate4 weeks after embryo transferPresence of at least one fetal heart pulsation per fresh embryo transfer 4 weeks after transfer

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 20, 2026