Does Local Injury of the Endometrium Improve Controlled Ovarian Hyperstimulation (COH) + Intrauterine Insemination (IUI) Outcome?
Exploration of the Possibility That Local Injury of the Endometrium Has the Same Beneficial Effect on IUI Outcome as Demonstrated in IVF Treatment
1 other identifier
interventional
600
1 country
1
Brief Summary
It was previously demonstrated in in vitro fertilization (IVF) patients that local injury of the endometrium during a spontaneous menstrual cycle that precedes IVF treatment doubled the rates of implantation and pregnancy. The hypothesis of our present study is that the endometrial injury procedure will have the same beneficial effect in patients undergoing controlled ovarian hyperstimulation (COH) combined with intrauterine insemination (IUI).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2010
CompletedFirst Posted
Study publicly available on registry
April 28, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedMarch 16, 2012
March 1, 2012
2.3 years
April 21, 2010
March 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Clinical Pregnancy rate
1 year
Secondary Outcomes (1)
Live birth
2 years
Study Arms (6)
Clomiphene citrate + IUI + endometrial biopsy
EXPERIMENTALClomiphene citrate + IUI + endometrial biopsy
Clomiphene citrate + IUI
NO INTERVENTIONgonadotrophines + IUI + endometrial biopsy
EXPERIMENTALtwo endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.
gonadotrophines + IUI
NO INTERVENTIONnatural cycle + IUI + endometrail biopsy
EXPERIMENTALtwo endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.
natural cycle + IUI
NO INTERVENTIONInterventions
two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.
two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.
Eligibility Criteria
You may qualify if:
- age 18-38.
- infertility.
- patients undergoing IUI treatment.
- at least one failed IUI cycle.
You may not qualify if:
- indication for IVF treatment.
- Known Pelvic inflammatory disease(PID).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Remez women medical center
Rehovot, Israel
Related Publications (1)
Barash A, Dekel N, Fieldust S, Segal I, Schechtman E, Granot I. Local injury to the endometrium doubles the incidence of successful pregnancies in patients undergoing in vitro fertilization. Fertil Steril. 2003 Jun;79(6):1317-22. doi: 10.1016/s0015-0282(03)00345-5.
PMID: 12798877BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yuval Or, MD
Clalit health service
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 21, 2010
First Posted
April 28, 2010
Study Start
June 1, 2010
Primary Completion
September 1, 2012
Study Completion
October 1, 2012
Last Updated
March 16, 2012
Record last verified: 2012-03