Intrauterine Autologous PRP Infusion Compared to HRT for Enhancing Endometrial Thickness in Patients Undergoing ICSI

NCT ID: NCT02660294

Last Updated: 2016-03-22

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

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-04-30

Brief Summary

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Successful embryo implantation needs an optimum embryonic development with a receptive endometrium. Endometrial thickness is an independant factor for endometrial receiptivity. The aim of that trial is to assess the benefecial effect of platelt rich plasma in copmarison with standard hormonal therapy.

Detailed Description

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This is a single blinded randomized trial comparing the effect of of platlet rich plasma versus hormonal therapy on endometrial thickness and consequently endometrial receptivity. The primary endpoint of this trial is clinical pregnancy rate.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Platlet rich plasma

For those with endometrial thickness less than 7 mm intrauterine injection of platlet rich plasma (PRP) for enhancing endometrial thickness and receptivity

Group Type EXPERIMENTAL

platlet rich plasma

Intervention Type BIOLOGICAL

Platelet-rich plasma (PRP) is prepared from fresh whole blood which is collected from a peripheral vein, stored in acid citrate dextrose solution A (ACD-A) anticoagulant and processed to increase platelets by separating various components of blood

Hormone replacement therapy

Oral intake of estradiol valerate for those with endometrial thickness less than 7 mm will improve endometrial receptivity

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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platlet rich plasma

Platelet-rich plasma (PRP) is prepared from fresh whole blood which is collected from a peripheral vein, stored in acid citrate dextrose solution A (ACD-A) anticoagulant and processed to increase platelets by separating various components of blood

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* patients undergoing ICSI
* endometrial thickness less than 7 mm on early follicular phase

Exclusion Criteria

\-
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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rasha medhat abdul-hady

DR. Rasha Medhat Abdul-hady

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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RASHA DR MEDHAT, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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Rasha

Cairo, Cairo Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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rasha Dr medhat, MD

Role: CONTACT

1224448449 ext. 0020

ahmed DR kotb, MD

Role: CONTACT

1008681999 ext. 0020

Facility Contacts

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Rasha M Abdul-hady, MD

Role: primary

1224448449 ext. 0020

ahmed M kotb, MD

Role: backup

1004711414 ext. 0020

Other Identifiers

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PRP-IVF

Identifier Type: -

Identifier Source: org_study_id

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