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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03100240
Other study ID # 81501328
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date August 28, 2017
Est. completion date September 30, 2018

Study information

Verified date January 2022
Source Reproductive & Genetic Hospital of CITIC-Xiangya
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

NF-κB pathway activation-induced endometrial insulin resistance was one of the causes of infertility patients with PCOS and insulin resistance whose endometrial receptivity is declined .The investigators' previous findings indicated that the use of modified utral-long protocols ( GnRH-a was used twice in mid-luteal phaes) can improve clinical outcomes by improving endometrial receptivity in patients with PCOS , but the mechanism was not clear. Previous research also found that GnRH-a reduced the activity of NF-κB pathway in endometrial stromal cells and depended the dose and time.Thus, The investigators' subject will try to applicate GnRH-a to explore the influence of NF-κB pathway activity 、the state of insulin resistance and embryo implantation rate ;then we will investgate GnRH-a whether reduce NF-κB pathway activity-induced insulin resistance and ultimately improve endometrial receptivity by using GnRH-a in infertility patients with PCOS and insulin resistance.The investigators' research attempt to provide ideas for seeking inflammatory medication target in assisted reproductive technology in patients with PCOS by exploring the immune mechanism of GnRHa on improving the endometrial receptivity .


Description:

The endometrial biopsy was performed in the previous cycle of the protocol. According to the expression of NF-κB in the endometrium random group. The difference of NF - κB expression in patients with different protocol were compared.


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date September 30, 2018
Est. primary completion date September 15, 2018
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria: - age<36years, - PCOS, - Insulin resistance (HOMA-IR = fasting insulin (FINS) × fasting blood glucose (FPG) / 22.5, HOMA-IR = 2.69 ); Exclusion Criteria: - uterine abnormalities (double uterus, bicornuate uterus, unicornuate uterus and uterine mediastinum), - intrauterine adhesions, - endometriosis, adenomyosis, - Hydrosalpinx, - uterine fibroids (submucosal fibroids, non-mucosal fibroids > 4 cm and / or endometrial pressure), - Hyroid dysfunction and hyperprolactinemia.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Modified Supper Long Protocol
In Modified Supper Long Protocol, GnRH-a was used twice in mid-luteal phaes

Locations

Country Name City State
China Reproductive & Genetic Hospital of CITIC-XIANGYA Changsha Hunan

Sponsors (1)

Lead Sponsor Collaborator
Reproductive & Genetic Hospital of CITIC-Xiangya

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary clinical pregnancy rate a beating heart tube was 99 detected by ultrasound examination 28 days after transplantation
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