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

NCT02855632 | Unknown DMC

• 1 other identifier: SRRSHRMC2016001
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Intrauterine Adhesion

Keywords

G-CSF; adhesion reformation; Asherman syndrome

Outcome Measures

Primary Outcomes (1)

• Adhesion reformation rate

  Adhesion reformation rate after first adhesiolysis

  2 months after first surgery

Secondary Outcomes (2)

• Pregnancy rate

  3 years after first surgery

• Live birth rate

  4 years after first surgery

Other Outcomes (1)

• Endometrial thickness

  1 months after G-CSF injection

Study Arms (2)

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

G-CSF DRUG

7 days after first hysteroscopic adhesiolysis, G-CSF will be injected into the uterine cavity after balloon removing.

Also known as: granulocyte colony-stimulating factor

G-CSF

Normal saline DRUG

7 days after first hysteroscopic adhesiolysis, normal saline will be injected into the uterine cavity after balloon removing.

Also known as: 0.9% NaCl, 0.9% sodium chloride

Normal saline

hormone therapy DRUG

In all cases hormone therapy was commenced shortly after the operation, consisting of oestradiol valerate at a dose of 6 mg per day for 21-28 days with the addition of medroxyprogesterone acetate at a dose of 6 mg per day for the last 7-10 days of the oestrogen therapy. Following the withdrawal bleed, the hormone therapy was repeated for another cycle.

Also known as: Artificial cycle, Artificial menstrual cycle, Estrogen and Progesterone Sequential Therapy

G-CSF; Normal saline

Cook balloon OTHER

At the end of the procedure, the Cook balloon were placed in the uterine cavity of each patient.the device was removed after 7 days.

G-CSF; Normal saline

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead
• Wenzhou people's hospital，zhejiang province,China: collaborator
• Ningbo Women & Children's Hospital: collaborator

Study Sites (1)

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310018, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 35147195 DERIVED

MeSH Terms

Conditions

Gynatresia

Interventions

Granulocyte Colony-Stimulating Factor; Saline Solution; Sodium Chloride; Estrogens

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Xiaona Lin, Doctor

  Sir Run Run Shaw Hospital

  STUDY DIRECTOR

Central Study Contacts

Xiaona Lin, Doctor

CONTACT

+8657186006252; linna73@263.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 3, 2016
• First Posted: August 4, 2016
• Study Start: August 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: January 5, 2018

Record last verified: 2018-01

Locations

CN (1)