Uterine Lesions and Their Association to Invitro Fertilization(IVF) or Intracytoplasmic Sperm Injection(ICSI) Outcome
Association Between Uterine , Intracavitary , Cervical and Cervical Canal Lesions With in Vitro Fertilization/Intracytoplasmic Sperm Injection(IVF/ICSI) Outcome.
1 other identifier
observational
122
0 countries
N/A
Brief Summary
- 1.To study the effect of uterine wall , intracavitary , cervical as well as cervical canal lesion on the outcome of IVF/ICSI cycle.
- 2.To establish a score for prediction of IVF/ICSI cycle success .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2021
Typical duration for all trials
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
June 17, 2021
CompletedFirst Posted
Study publicly available on registry
June 25, 2021
CompletedStudy Start
First participant enrolled
July 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedJune 30, 2021
June 1, 2021
2.7 years
June 17, 2021
June 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Pregnancy rate
Pregnancy rate with IVF/ICSI with uterine lesions
Baseline
Study Arms (2)
Group A
Women with hysteroscopically or ultrasonographic detected uterine anomalies(adenomyosis,fibroid) intracavitary lesions ( like polyp, adhesion or septum) and those with detected endometrial abnormalities (like hypervascularization,pale endometrium) ,cervical lesion and cervical canal lesion or pelvic lesion
Group B
Matched women (eg. Age,parity, BMI, ovarian reserve….) with no uterine or ovarian abnormalities assessed by hysteroscopy or ultrasonography.
Interventions
Eligibility Criteria
Women between 18 and 38 years old. * An indication for IVF/ICSI.. * Women with BMI between 18.5 : 29.9 .
You may qualify if:
- Women between 18 and 38 years old.
- An indication for IVF/ICSI..
- Women with BMI between 18.5 : 29.9 .
- Women with normal antimullerian hormone(AMH), antral follicle count(AFC) (good responders).
You may not qualify if:
- Refusal to join the study.
- Women with age less than 18 and more than 38 .
- Women with BMI less than 18.5 and more than 30 .
- Untreated tubal hydrosalpinges.
- Poor responders as assessed by AFC 4 or less ,AMH O.8 ng/dl (nice 2013).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
Rai R, Regan L. Recurrent miscarriage. Lancet. 2006 Aug 12;368(9535):601-11. doi: 10.1016/S0140-6736(06)69204-0.
PMID: 16905025BACKGROUNDDicker D, Ashkenazi J, Feldberg D, Farhi J, Shalev J, Ben-Rafael Z. The value of repeat hysteroscopic evaluation in patients with failed in vitro fertilization transfer cycles. Fertil Steril. 1992 Oct;58(4):833-5. doi: 10.1016/s0015-0282(16)55338-2.
PMID: 1426335BACKGROUNDLevi Setti PE, Colombo GV, Savasi V, Bulletti C, Albani E, Ferrazzi E. Implantation failure in assisted reproduction technology and a critical approach to treatment. Ann N Y Acad Sci. 2004 Dec;1034:184-99. doi: 10.1196/annals.1335.021.
PMID: 15731311BACKGROUND
Study Officials
- STUDY DIRECTOR
Momen Kamel, Prof.dr
Assiut University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- doctor
Study Record Dates
First Submitted
June 17, 2021
First Posted
June 25, 2021
Study Start
July 1, 2021
Primary Completion
March 1, 2024
Study Completion
April 1, 2024
Last Updated
June 30, 2021
Record last verified: 2021-06