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Hysteroscopy With Fundus Uterus Scratching Incision VS Office Hysteroscopy Before ET With Donor Eggs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04580056
Recruitment Status : Active, not recruiting
First Posted : October 8, 2020
Last Update Posted : October 8, 2020
Sponsor:
Collaborator:
3rd Department of Obstetrics and Gynaecology, Aristotle University of Thessaloniki
Information provided by (Responsible Party):
Papanikolaou Evaggelos, Assisting Nature

Study Description
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Brief Summary:
A prospective randomised control trial of the impact of the fundus edometrial incision during hysteroscopy in oocyte recipients.

Condition or disease Intervention/treatment
Hysteroscopy, Oocyte Recipients Procedure: Uterine fundus endometrial incision during hysteroscopy

Detailed Description:

A prospective randomised control trial of the impact of the fundus edometrial incision during hysteroscopy in women without intrauterine pathology which is likely to have an adverse effect on reproductive outcomes. The study populations will be constituted by oocyte recipients.

Study group: Hysteroscopy with fundus endometrial incision Control group: Office Hysteroscopy without any endometrial injury

Study Design
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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Oocyte Recipients Before Embryo Transfer Randomization: Hysteroscopy With Fundus Uterus Scratching VS Hysteroscopy Without Fundus Uterus Scratching
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022
Groups and Cohorts
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Group/Cohort Intervention/treatment
Incision Group
Women following IVF treatment with donor oocytes who underwent during hysteroscopy fundus endometrial scratching by incision, before embryo transfer.
 Procedure: Uterine fundus endometrial incision during hysteroscopy
Uterine fundus endometrial scratching during hysteroscopy by incision
No incision Group
Women following IVF treatment with donor oocytes who underwent office hysteroscopy without fundus endometrial scratching by incision, before embryo transfer.


Outcome Measures
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Primary Outcome Measures :
  1. Implantation Rate [ Time Frame: 6 weeks to 42 weeks after embryo transfer] ]
    Implantation rate

  2. Delivery Rate [ Time Frame: 6 weeks to 42 weeks after embryo transfer] ]
    Delivery Rate


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  • oocyte acceptors
  • age 30-50
  • embryo transfer with Hormone Replacement Therapy
  • embryo transfer within 6 months of hysteroscopy

Exclusion Criteria:

  • previous uterine pathology
  • sperm sample <1mil/ml
  • leiomyoma
  • septate uterus
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04580056


Locations
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Greece
Assisting Nature
Thessaloníki, Greece, 57001
Sponsors and Collaborators
Assisting Nature
3rd Department of Obstetrics and Gynaecology, Aristotle University of Thessaloniki
Investigators
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Principal Investigator: Evangelos Papanikolaou, PhD Assisting Nature, 3rd Department of Obstetrics and Gynaecology, Aristotle University of Thessaloniki
More Information
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Responsible Party: Papanikolaou Evaggelos, Prof Dr Papanikolaou G. Evangelos, Assisting Nature
ClinicalTrials.gov Identifier: NCT04580056    
Other Study ID Numbers: Uterus Incision- Don
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Papanikolaou Evaggelos, Assisting Nature:
Hysteroscopy
Fundus Endometrial Incision
Oocyte acceptors
pregnancy outcome
uterine scratching