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

October 2, 2020 updated by: Papanikolaou Evaggelos, Assisting Nature

Oocyte Recipients Before Embryo Transfer Randomization: Hysteroscopy With Fundus Uterus Scratching VS Hysteroscopy Without Fundus Uterus Scratching

A prospective randomised control trial of the impact of the fundus edometrial incision during hysteroscopy in oocyte recipients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloníki, Greece, 57001
        • Assisting Nature

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implantation Rate
Time Frame: 6 weeks to 42 weeks after embryo transfer]
Implantation rate
6 weeks to 42 weeks after embryo transfer]
Delivery Rate
Time Frame: 6 weeks to 42 weeks after embryo transfer]
Delivery Rate
6 weeks to 42 weeks after embryo transfer]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assisting Nature

Collaborators

3rd Department of Obstetrics and Gynaecology, Aristotle University of Thessaloniki

Investigators

  • Principal Investigator: Evangelos Papanikolaou, PhD, Assisting Nature, 3rd Department of Obstetrics and Gynaecology, Aristotle University of Thessaloniki

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2020

Primary Completion (ANTICIPATED)

January 1, 2022

Study Completion (ANTICIPATED)

January 1, 2022

Study Registration Dates

First Submitted

October 2, 2020

First Submitted That Met QC Criteria

October 2, 2020

First Posted (ACTUAL)

October 8, 2020

Study Record Updates

Last Update Posted (ACTUAL)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 2, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Uterus Incision- Don

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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