The Effect of the GM-CSF Gel on the Endometrial Thickness in Infertile Women With Thin Endometrium

NCT04100655 | Unknown DMC

• 1 other identifier: SRRSH20190806-19
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the efficacy of the granulocyte-macrophage colony stimulating factor(GM-CSF) gel on the endometrial thickness in infertile women with thin endometrium.

Conditions

Thin Endometrium

Keywords

GM-CSF; frozen embryo transfer

Outcome Measures

Primary Outcomes (1)

• the endometrial thickness

  the endometrial thickness following the hormonal replacement treatment evaluated based on the ultrasound

  1 months after hysteroscopy examination

Secondary Outcomes (3)

• embryo transfer cancelation rate

  2 months after hysteroscopy examination

• uterine artery blood supply markers

  1 months after hysteroscopy examination

• pregnancy rate

  3 months after hysteroscopy examination

Study Arms (2)

GM-CSF

EXPERIMENTAL

Hysteroscopy will be arranged to confirm the uterine cavity is normal and there is no significant intrauterine adhesion. 3ml GM-CSF gel will be irrigated into the uterine cavity immediately when hysteroscopy is complete. Then same dose gel will be given every other day twice.

Drug: GM-CSF; Drug: 17-ß estradiol

Control

EXPERIMENTAL

Hysteroscopy will be arranged to confirm the uterine cavity is normal and there is no significant intrauterine adhesion. After hysteroscopy examination, nothing was applied to the uterine cavity.

Drug: 17-ß estradiol

Interventions

GM-CSF DRUG

3ml GM-CSF gel will be irrigated into the uterine cavity immediately when hysteroscopy is complete. Then same dose gel will be given every other day twice

Also known as: granulocyte-macrophage colony stimulating factor

GM-CSF

17-ß estradiol DRUG

A hormone replace treatment by 17-ß estradiol (6mg per day) follows next cycle to prepare for embryo transfer

Also known as: Femoston

Control; GM-CSF

Eligibility Criteria

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

You may qualify if:

• Woman undergoes IVF treatment, 18-40 years old
• The endometrial thickness \<7mm on the day of human chorionic gonadotropin during IVF or after taking oral estradiol valerate 6mg/d for 14 days.
• Embryo transfer is cancelled because of thin endometrium
• No intrauterine adhesion according to the 3-D ultrasonography

You may not qualify if:

• Systemic diseases unable to conceive
• Chromasome abnormal
• History of G-CSF or GM-CSF allergy or untoward effect
• Thin endometrium related to clomid
• Severe or moderate uterine adhesion
• The influence factor of embryo implantation: hydrosalpinx, endometriosis, adenomyosis,myoma of uterus
• Uterine malformation, adenomyosis, uterine leiomyoma sized more than 2cm.
• Patients who is allergic to granulocyte-macrophage colony stimulating factor
• Patients with inflammation of reproductive organs, pelvic cavity inflammation, malignant tumor of reproductive organs and other systemic diseases that could cause metrorrhagia

Sponsors & Collaborators

• Sir Run Run Shaw Hospital: lead

Study Sites (1)

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310018, China

Location

MeSH Terms

Interventions

Granulocyte-Macrophage Colony-Stimulating Factor; Colony-Stimulating Factors; femoston

Intervention Hierarchy (Ancestors)

Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of gynaecology and obstetrics

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 24, 2019
• Study Start: October 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 24, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)