Ignite Creation Date:
2024-05-06 @ 2:06 AM
Last Modification Date:
2024-10-26 @ 11:14 AM
Study NCT ID:
NCT01977976
Status:
COMPLETED
Last Update Posted:
2014-12-03
First Post:
2013-10-31
Brief Title:
RCT on the Effect of Endometrial Injury on Ongoing Pregnancy Rate in Subfertile Women Undergoing IVF
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
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
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 IUL Women randomized into the study group will have endometrial biopsy performed by pipelle 7 days after the LH surge LH7 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
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 IUL Women randomized into the study group will have endometrial biopsy performed by pipelle 7 days after the LH surge LH7 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None