Multi-factorial Analysis of the Follicular Fluid Milieu to Explore the Discrepant Effect of Follicular Fluid Endometrial Flushing on Outcome of Assisted Reproduction Trial
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Patients \& Methods: Eighty infertile women were randomly categorized into: Group EF (n=40) had EF after oocyte retrieval and Control group (n=40) did not have EF. All women were subjecte to the standard down-regulation regimen followed by controlled ovarian hyper stimulation . Oocytes were retrieved 34-36 h after hCG administration and aspirated FF was collected and centrifuged at 600 rpm for 10 min and 5-ml sample of supernatant was obtained for ELISA estimation of tumor necrosis factor-α (TNF-α), granulocyte colony-stimulating factor (G-CSF), leptin and anti-Mullerian Hormone (AMH) levels in both groups. The remaining amount was used for EF in EF group and was discarded in control group. Pregnancy was diagnosed by measurement of β-HCG level and confirmed by transvaginal sonography as clinical pregnancy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2013
Typical duration for phase_2
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 6, 2015
CompletedFirst Posted
Study publicly available on registry
June 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedSeptember 20, 2016
September 1, 2016
4.4 years
June 6, 2015
September 16, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
pregnancy rates.
after retriveal by 14 days
Study Arms (2)
endometrial flushing (A)
ACTIVE COMPARATOROocytes were retrieved 34-36 h after hCG administration and aspirated FF was collected in a sterile container and was centrifuged at 600 rpm for 10 min at room temperature and a 5-ml sample of the supernatant was obtained for laboratory workup, while the remaining amount of supernatant was used to flush the endometrium through an applied uterine catheter in FF group and was discarded in the other group.
B
NO INTERVENTIONno intervention Control group included 40 women would not have FF endometrial flushing.
Interventions
Oocytes were retrieved 34-36 h after hCG administration and aspirated FF was collected and centrifuged at 600 rpm for 10 min and 5-ml sample of supernatant was obtained for ELISA estimation of tumor necrosis factor-α (TNF-α), granulocyte colony-stimulating factor (G-CSF), leptin and anti-Mullerian Hormone (AMH) levels in both groups. The remaining amount was used for endometrial flushing
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Benha Universitylead
Study Sites (1)
Banha Universty
Banhā, El Qalubia, 13518, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ahmed saad, MD
Benha University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecutrer
Study Record Dates
First Submitted
June 6, 2015
First Posted
June 10, 2015
Study Start
January 1, 2013
Primary Completion
June 1, 2017
Study Completion
July 1, 2017
Last Updated
September 20, 2016
Record last verified: 2016-09