Concentrate of Autologous Rich Plasma in Growth Factors i... | NCT03387501

Studies
Concentrate of Autologous Rich Plasma in Growth Factors in the Treatment of the Thin Endometrium

NCT03387501

Sponsor

Sara Rafael Fernandez

Status

Completed

Last Update Posted

Sep 8, 2022Actual

Enrollment

13Actual

Phase

Phase 2

Conditions

Infertility
Infertility, Female

Interventions

Plasma rich in growth factors (PRGF-Endoret)

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 27, 2019Actual

Primary Completion Date

Jul 26, 2022Actual

Completion Date

Jul 26, 2022Actual

First Submitted Date

Dec 22, 2017

First Submission Date that Met QC Criteria

Dec 22, 2017

First Posted Date

Jan 2, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 7, 2022

Last Update Posted Date

Sep 8, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sara Rafael Fernandez, Head of Assisted Reproduction Laboratory, Hospital San Carlos, MadridSponsor-Investigator

Lead Sponsor

Sara Rafael FernandezOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study evaluate the percentage of women with thin endometrium who achieve an endometrial thickness equal to or greater than 7 mm after administration of PRGF (plasma rich in growth factors)

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PRGF	Experimental	Plasma rich in growth factors (PRGF) administration	Drug: Plasma rich in growth factors (PRGF-Endoret)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Plasma rich in growth factors (PRGF-Endoret)	Drug	Intrauterine administration of PRGF	PRGF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of women who achieve an endometrial thickness equal to or greater than 7 mm	Measurement of the endometrial thickness by ultrasonography.	3 days after administration of PRGF

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women who signed informed consent.
Women who understand the Spanish language.
Women under 42 years

Exclusion Criteria:

Thrombopenia.
Congenital or acquired uterine malformations that reduce embryo implantation or term gestation.
Ovarian tumors.
Benign uterine tumors require surgical treatment
Local acute inflammatory diseases
Patients with malignant tumors requiring chemotherapy.
Patients with acute or chronic infectious or inflammatory diseases requiring active treatment with drugs that may interfere with implantation and gestation.
Chronic treatment with NSAIDs (Nonsteroidal anti-inflammatory drugs)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sara Rafael, PhD	Hospital Clinico San Carlos	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Clinico San Carlos		Madrid		28040	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility
D007247	Infertility, Female

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D036341	Intercellular Signaling Peptides and Proteins

Ancestor Terms

ID	Term
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011506	Proteins
D001685	Biological Factors

Browse Leaves

Not provided

Browse Branches

Not provided