The Efficacy of G-CSF Against Adhesion Reformation After... | NCT02855632

Studies
The Efficacy of G-CSF Against Adhesion Reformation After Hysteroscopic Adhesiolysis

NCT02855632

Sponsor

Sir Run Run Shaw Hospital

Status

Unknown status

Last Update Posted

Jan 5, 2018Actual

Enrollment

240Estimated

Phase

Not Applicable

Conditions

Intrauterine Adhesion

Interventions

G-CSF
Normal saline
hormone therapy
Cook balloon

Countries

China

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

Jan 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2016

Primary Completion Date

Dec 2018Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Apr 3, 2016

First Submission Date that Met QC Criteria

Aug 1, 2016

First Posted Date

Aug 4, 2016Estimated

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

Jan 4, 2018

Last Update Posted Date

Jan 5, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Xiaona Lin, MD, Sir Run Run Shaw HospitalPrincipal Investigator

Lead Sponsor

Sir Run Run Shaw HospitalOTHER

Collaborators

Name	Class
Wenzhou people's hospital，zhejiang province,China	UNKNOWN
Ningbo Women & Children's Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The purpose of this study is to investigate the efficacy of Granulocyte Colony Stimulating Factor(G-CSF) on decreasing adhesion reformation and improving fertility outcomes after hysteroscopic adhesiolysis in patients with moderate to severe intrauterine adhesions.

Detailed Description

After hysteroscopic adhesiolysis, patients with moderate to severe intrauterine adhesions will be allocated into 2 groups randomly, with COOK ballon and estrogen and progesterone sequential therapy given to prevent adhesion routinely. 7 day later, G-CSF or normal saline will be injected into the uterine cavity by Tom catheter after removing the balloon respectively. A second hysteroscopic examination will be performed in 2 months to check up the adhesion reformation. In addition, the endometrial thickness after surgery and fertility outcome will be followed up.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
G-CSF	Experimental	G-CSF(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis.	Drug: G-CSF Drug: hormone therapy Other: Cook balloon
Normal saline	Placebo Comparator	equal volume of normal saline(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis.	Drug: Normal saline Drug: hormone therapy Other: Cook balloon

Interventions

Name	Type	Description	Arm Group Labels	Other Names
G-CSF	Drug	7 days after first hysteroscopic adhesiolysis, G-CSF will be injected into the uterine cavity after balloon removing.	G-CSF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adhesion reformation rate	Adhesion reformation rate after first adhesiolysis	2 months after first surgery

Secondary Outcomes

Measure	Description	Time Frame
Pregnancy rate	pregnancy rate after adhesiolysis	3 years after first surgery
Live birth rate	live birth rate after adhesiolysis	4 years after first surgery

Other Outcomes

Measure	Description	Time Frame
Endometrial thickness	Endometrial thickness in the ovulation phase after G-CSF injection	1 months after G-CSF injection

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Moderate and severe intrauterine adhesion patients(AFS score ≥5)
age 18-40
first time receiving hysteroscopic adhesiolysis
provided COOK balloon as adjuvant adhesion prevention treatment
accepting randomized trial

Exclusion Criteria:

Mild adhesion patients
uterine shape can't be restored in the end of surgery
abnormal chromosome phenotype
systemic disease
no fertility desire
contradiction of G-CSF injection.

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

Name	Role	Phone	Extension	Email
Xiaona Lin, Doctor	Contact	+8657186006252		linna73@263.net

Overall Officials

Name	Affiliation	Role
Xiaona Lin, Doctor	Sir Run Run Shaw Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sir Run Run Shaw Hospital	Recruiting	Hangzhou	Zhejiang	310018	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35147195	Derived	Zhang Y, Chen X, Chen S, Wei C, Li B, Wang Z, Shen X, Lin X. Intrauterine administration of G-CSF for promoting endometrial growth after hysteroscopic adhesiolysis: a randomized controlled trial. Hum Reprod. 2022 Apr 1;37(4):725-733. doi: 10.1093/humrep/deac023.

ID	Term
D005831	Genital Diseases, Female
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

ID	Term
D016179	Granulocyte Colony-Stimulating Factor
D000077330	Saline Solution
D012965	Sodium Chloride
D004967	Estrogens

ID	Term
D003115	Colony-Stimulating Factors
D006023	Glycoproteins
D006001	Glycoconjugates
D002241	Carbohydrates