Intrauterine AdhesionNCT02855632
The Efficacy of G-CSF Against Adhesion Reformation After Hysteroscopic Adhesiolysis
A study testing G-CSF, Normal saline and hormone therapy in people with Intrauterine Adhesion, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Intrauterine Adhesion
- What is being tested?
- G-CSF, Normal saline and hormone therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310018
Yamei Xue, Master, +8657186002222, yaya7450@sina.com
About this study
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.
Read the 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
- Being tested
- G-CSF, Normal saline, hormone therapy, Cook balloon
- Keywords
- G-CSF, adhesion reformation, Asherman syndrome
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G-CSFDrug
Also called granulocyte colony-stimulating factor
7 days after first hysteroscopic adhesiolysis, G-CSF will be injected into the uterine cavity after balloon removing.
Normal salineDrug
Also called 0.9% NaCl, 0.9% sodium chloride
7 days after first hysteroscopic adhesiolysis, normal saline will be injected into the uterine cavity after balloon removing.
hormone therapyDrug
Also called Artificial cycle, Artificial menstrual cycle, Estrogen and Progesterone Sequential 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.
Cook balloonOther
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.
| Study group | Role | What they receive |
|---|---|---|
| G-CSF | Experimental | G-CSF(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis. Receives: 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. Receives: Drug: Normal saline; Drug: hormone therapy; Other: Cook balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adhesion reformation rate
Adhesion reformation rate after first adhesiolysis
Measured: 2 months after first surgery
Secondary outcomes (2)
Pregnancy rate
pregnancy rate after adhesiolysis
Measured: 3 years after first surgery
Live birth rate
live birth rate after adhesiolysis
Measured: 4 years after first surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intrauterine AdhesionStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wenzhou people's hospital，zhejiang province,China, Ningbo Women & Children's Hospital
- Responsible party
- Principal investigator, Xiaona Lin, Sir Run Run Shaw Hospital
- Investigators
- Xiaona Lin, Doctor, Study director, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02855632
- Sponsor's protocol ID
- SRRSHRMC2016001
- Status last verified
- Jan 2018
- First submitted
- 3 Apr 2016
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 35147195
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of G-CSF Against Adhesion Reformation After Hysteroscopic Adhesiolysis
- ClinicalTrials.gov ID
- NCT02855632
- Acronym / sponsor ID
- SRRSHRMC2016001
- Conditions
- Intrauterine Adhesion
- Keywords
- G-CSF, adhesion reformation, Asherman syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Collaborators
- Wenzhou people's hospital，zhejiang province,China, Ningbo Women & Children's Hospital
- Study start
- Aug 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 4 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G-CSF | Experimental | Drug: G-CSF, Drug: hormone therapy, Other: Cook balloonG-CSF(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis. |
| Normal saline | Placebo comparator | Drug: Normal saline, Drug: hormone therapy, Other: Cook balloonequal volume of normal saline(1.8ml) will be injected into the uterine cavity by insemination catheter 7 days after first hysteroscopic adhesiolysis. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Mild adhesion patients
- uterine shape can't be restored in the end of surgery
- abnormal chromosome phenotype
- systemic disease
- no fertility desire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G-CSFAlso: granulocyte colony-stimulating factor7 days after first hysteroscopic adhesiolysis, G-CSF will be injected into the uterine cavity after balloon removing. | Drug | G-CSF |
| Normal salineAlso: 0.9% NaCl, 0.9% sodium chloride7 days after first hysteroscopic adhesiolysis, normal saline will be injected into the uterine cavity after balloon removing. | Drug | Normal saline |
| hormone therapyAlso: Artificial cycle, Artificial menstrual cycle, Estrogen and Progesterone Sequential TherapyIn 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. | Drug | G-CSF, Normal saline |
| Cook balloonAt the end of the procedure, the Cook balloon were placed in the uterine cavity of each patient.the device was removed after 7 days. | Other | G-CSF, Normal saline |
Primary outcome
Adhesion reformation rate
Time frame: 2 months after first surgery
Adhesion reformation rate after first adhesiolysis
2 secondary outcomes
Pregnancy rate
Time frame: 3 years after first surgery
Live birth rate
Time frame: 4 years after first surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
- Derived from this study: PubMed 35147195Zhang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaona Lin, Doctor study director
Sir Run Run Shaw Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G-CSF, Normal saline and hormone therapy in people with Intrauterine Adhesion, run by Sir Run Run Shaw Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaona Lin, Doctor (+8657186006252, linna73@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adhesion reformation rate (time frame: 2 months after first surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02855632, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2018.