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

NCT ID: NCT04580056

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-01-31

Brief Summary

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

Detailed Description

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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

Conditions

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Hysteroscopy, Oocyte Recipients

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Incision Group

Women following IVF treatment with donor oocytes who underwent during hysteroscopy fundus endometrial scratching by incision, before embryo transfer.

Uterine fundus endometrial incision during hysteroscopy

Intervention Type PROCEDURE

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.

No interventions assigned to this group

Interventions

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Uterine fundus endometrial incision during hysteroscopy

Uterine fundus endometrial scratching during hysteroscopy by incision

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Aristotle University Of Thessaloniki

OTHER

Sponsor Role collaborator

Assisting Nature

OTHER

Sponsor Role lead

Responsible Party

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Papanikolaou Evaggelos

Prof Dr Papanikolaou G. Evangelos

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Evangelos Papanikolaou, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Assisting Nature

Thessaloniki, , Greece

Site Status

Countries

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Greece

References

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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.

Reference Type DERIVED
PMID: 39033364 (View on PubMed)

Other Identifiers

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Uterus Incision- Don

Identifier Type: -

Identifier Source: org_study_id

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