Endometrial Injury and Implantation Rates Before First ICSI Cycle

NCT ID: NCT02660125

Last Updated: 2024-02-01

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

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-03-31

Brief Summary

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Midluteal single endometrial strip will be taken using a Novak curett under general anasthesia to avoid discomfort and cramping and to proceed to cervical dilatation in case of forbidden cervix, the step that will be beneficial to embryo transfer procedure.

Controller ovarian hyperstimulation; will be done using the long luteal phase agonist protocol and the short protocol(as judged by patient,s age ovarian reserve judged by day 3 FSH and antral follicular count and previous history of ovarian response).

Ovarian response will be monitored by vaginal ultrasound and HCG will be given when when there is \>=1 follicle \>=18 mm. and \>=3 follicles \>=16 mm. Ultasound guided oocyte retrieval will be carried out 35 hours later. Embryo transfer will be performed on day 2 or day 3 after oocyt retrieval according to number and quality of embryos.

Embryo transfer will be carried out under trans-abdominal ultrasound guidance pregnancy test will be done using qualitative blood HCG detection 2 weeks after the embryo transfer.

Detailed Description

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Conditions

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Invitro Fertilization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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endometrial scratch injury

endometrial scratch done before ICSI cycle

Group Type ACTIVE_COMPARATOR

Endometrial scratch injury

Intervention Type PROCEDURE

midluteal single endometrial strip will be taken using a Novak curett under general anasthesia to avoid discomfort and cramping and to proceed to cervical dilatation in case of forbidden cervix

control

IcSI cycle without prior endometrial injury

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Endometrial scratch injury

midluteal single endometrial strip will be taken using a Novak curett under general anasthesia to avoid discomfort and cramping and to proceed to cervical dilatation in case of forbidden cervix

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. subfertile women indicated for ICSI.
2. normal uterine cavity demonstrated by transvaginal ultrasound and hystrogram.
3. FSH\<10mIU/mL on day 3 of her cycle.

Exclusion Criteria

1. presence of endometrial polyp or fibroid distorting the uterine cavity.
2. hydrosalpinx.
3. ICSI carried out for preimplantation genetic diagnosis.
4. FSH\>10mIU\\mL.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed M Maged, MD

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Maged

Role: PRINCIPAL_INVESTIGATOR

Kasr Alainy medical school

Locations

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Kasr Alainy medical school

Cairo, , Egypt

Site Status

Countries

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Egypt

References

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Maged AM, Rashwan H, AbdelAziz S, Ramadan W, Mostafa WAI, Metwally AA, Katta M. Randomized controlled trial of the effect of endometrial injury on implantation and clinical pregnancy rates during the first ICSI cycle. Int J Gynaecol Obstet. 2018 Feb;140(2):211-216. doi: 10.1002/ijgo.12355. Epub 2017 Nov 18.

Reference Type DERIVED
PMID: 29048754 (View on PubMed)

Other Identifiers

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144

Identifier Type: -

Identifier Source: org_study_id

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