Effect of Endometrial Injury Before Frozen Embryo Transfer on Pregnancy Rate
1 other identifier
interventional
50
1 country
1
Brief Summary
Research Question: In women undergoing frozen embryo transfer, does routine endometrial injury before frozen embryo transfer increase clinical pregnancy rate? Research Hypothesis: (Null Hypothesis) In women undergoing frozen embryo transfer Routine endometrial injury before frozen embryo transfer does not increase clinical pregnancy rate. (Alternative Hypothesis) In women undergoing frozen embryo transfer, endometrial injury before the transfer may increase pregnancy rate.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2017
Shorter than P25 for phase_4
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
Study Start
First participant enrolled
March 8, 2017
CompletedFirst Submitted
Initial submission to the registry
June 15, 2017
CompletedFirst Posted
Study publicly available on registry
July 18, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedJuly 18, 2017
July 1, 2017
6 months
June 15, 2017
July 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Chemical pregnancy rate
serum Beta -Human Chorionic Gonadotropin positive
two weeks after frozen embryo transfer
Secondary Outcomes (1)
Clinical pregnancy rate
four weeks after frozen embryo transfer
Study Arms (2)
Group (A)
EXPERIMENTALconsists of 25 patients will receive frozen embryo with endometrial scratching on day 7 of transfer cycle.
Group (B)
NO INTERVENTIONconsists of 25 patients will receive frozen embryo without endometrial scratching as control group.
Interventions
single induced injury will be done on the posterior endometrium on day 7 of the transfer cycle by using modified Cook catheter.
Eligibility Criteria
You may qualify if:
- All infertile women have high quality frozen embryos.
You may not qualify if:
- History of endocrine disease such as: diabetes; Hyperthyroidism and Hyperprolactinemia.
- History of hysteroscopic surgery due to intrauterine adhesions.
- History of cardiovascular, renal or liver disease .
- History of stroke or myocardial infarction.
- Poor quality embryos.
- Alcohol or Substance abuse.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ART unit - Ain Shams university Matrnity Hospital
Cairo, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Adel Sh Salah El-Din, Ass. Prof.
Ain Shams University
- STUDY DIRECTOR
Mohammed A Faris, Lecturer
Ain Shams University
- STUDY DIRECTOR
Mohamed E Shawky, Lecturer
Ain Shams University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 15, 2017
First Posted
July 18, 2017
Study Start
March 8, 2017
Primary Completion
September 9, 2017
Study Completion
October 1, 2017
Last Updated
July 18, 2017
Record last verified: 2017-07