- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01977976
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
Study Overview
Status
Conditions
Intervention / 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Hong Kong, Hong Kong
- University of Hong Kong
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Endometrial Aspirate (EA) group
Endometrial aspirate by pipelle
|
Endometrial aspiration by pipelle is to be performed on LH+7 in the cycle preceding scheduled IVF treatment
|
No Intervention: Control group
No intervention prior to scheduled IVF
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ongoing pregnancy rate
Time Frame: 10-12 weeks gestation
|
Ongoing pregnancy rate per fresh embryo transfer
|
10-12 weeks gestation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
implantation rate
Time Frame: 4 weeks after embryo transfer
|
number of gestation sac on pelvic scan per number of embryo transferred
|
4 weeks after embryo transfer
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
4 weeks after embryo transfer
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tracy Yeung, MRCOG, The University of Hong Kong
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TY03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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