Hysteroscopy With Fundus Uterus Scratching Incision VS Office Hysteroscopy Before ET With Donor Eggs
Oocyte Recipients Before Embryo Transfer Randomization: Hysteroscopy With Fundus Uterus Scratching VS Hysteroscopy Without Fundus Uterus Scratching
1 other identifier
observational
120
1 country
1
Brief Summary
A prospective randomised control trial of the impact of the fundus edometrial incision during hysteroscopy in oocyte recipients.
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 Jan 2020
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
January 1, 2020
CompletedFirst Submitted
Initial submission to the registry
October 2, 2020
CompletedFirst Posted
Study publicly available on registry
October 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedOctober 8, 2020
October 1, 2020
2 years
October 2, 2020
October 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Implantation Rate
Implantation rate
6 weeks to 42 weeks after embryo transfer]
Delivery Rate
Delivery Rate
6 weeks to 42 weeks after embryo transfer]
Study Arms (2)
Incision Group
Women following IVF treatment with donor oocytes who underwent during hysteroscopy fundus endometrial scratching by incision, before embryo transfer.
No incision Group
Women following IVF treatment with donor oocytes who underwent office hysteroscopy without fundus endometrial scratching by incision, before embryo transfer.
Interventions
Uterine fundus endometrial scratching during hysteroscopy by incision
Eligibility Criteria
Women 30-50 years old with infertility undergoing IVF treatment with donor oocytes. 1-2 blastocysts are transferred per cycle with endometrium preparation with Hormone Replacement Therapy.The study population has underwent hysteroscopy with fundus endometrial incision before the embryo transfer.
You may qualify if:
- oocyte acceptors
- age 30-50
- embryo transfer with Hormone Replacement Therapy
- embryo transfer within 6 months of hysteroscopy
You may not qualify if:
- previous uterine pathology
- sperm sample \<1mil/ml
- leiomyoma
- septate uterus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assisting Naturelead
- Aristotle University Of Thessalonikicollaborator
Study Sites (1)
Assisting Nature
Thessaloniki, 57001, Greece
Related Publications (1)
Peitsidis N, Tsakiridis I, Najdecki R, Michos G, Kalogiannidis I, Athanasiadis A, Papanikolaou E. Hysteroscopic Endometrial Fundal Incision versus Hysteroscopy Only in Oocyte Recipients: A Randomized Controlled Trial Assessing The Reproductive Outcomes. Int J Fertil Steril. 2024 Jul 13;18(Suppl 1):3-9. doi: 10.22074/ijfs.2024.2009369.1523.
PMID: 39033364DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Evangelos Papanikolaou, PhD
Assisting Nature, 3rd Department of Obstetrics and Gynaecology, Aristotle University of Thessaloniki
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof Dr Papanikolaou G. Evangelos
Study Record Dates
First Submitted
October 2, 2020
First Posted
October 8, 2020
Study Start
January 1, 2020
Primary Completion
January 1, 2022
Study Completion
January 1, 2022
Last Updated
October 8, 2020
Record last verified: 2020-10