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

NCT ID: NCT02855632

Last Updated: 2018-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2019-12-31

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.

Conditions

Intrauterine Adhesion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

G-CSF

G-CSF(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis.

Group Type: EXPERIMENTAL

G-CSF

Intervention Type: DRUG

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

hormone therapy

Intervention Type: 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.

Cook balloon

Intervention Type: 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.

Normal saline

equal volume of normal saline(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis.

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

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

hormone therapy

Intervention Type: 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.

Cook balloon

Intervention Type: 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.

Interventions

G-CSF

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

Intervention Type: DRUG

Normal saline

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

Intervention Type: DRUG

hormone therapy

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.

Intervention Type: DRUG

Cook balloon

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.

Intervention Type: OTHER

Other Intervention Names

granulocyte colony-stimulating factor; 0.9% NaCl; 0.9% sodium chloride; Artificial cycle; Artificial menstrual cycle; Estrogen and Progesterone Sequential Therapy

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Wenzhou people's hospital，zhejiang province,China

UNKNOWN

Sponsor Role: collaborator

Ningbo Women & Children's Hospital

OTHER

Sponsor Role: collaborator

Sir Run Run Shaw Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiaona Lin

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaona Lin, Doctor

Role: STUDY_DIRECTOR

Sir Run Run Shaw Hospital

Locations

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaona Lin, Doctor

Role: CONTACT

linna73@263.net

+8657186006252

Facility Contacts

Yamei Xue, Master

Role: primary

yaya7450@sina.com

+8657186002222

References

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.

Reference Type: DERIVED

PMID: 35147195 (View on PubMed)

Other Identifiers

SRRSHRMC2016001

Identifier Type: -

Identifier Source: org_study_id