Study Stopped
It is difficult to recruit patients.
The Mechanism of Modified Utral-long Protocol in Improving Endometrial Receptivity in Patients With PCOS and IR
The Preliminary Mechanism Study of Modified Utral-long Protocol in Improving Endometrial Receptivity in Patients With PCOS and Insulin Resistance
1 other identifier
interventional
6
1 country
1
Brief 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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2017
CompletedFirst Posted
Study publicly available on registry
April 4, 2017
CompletedStudy Start
First participant enrolled
August 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2018
CompletedJanuary 11, 2022
January 1, 2022
1 year
March 20, 2017
January 9, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
clinical pregnancy rate
a beating heart tube was 99 detected by ultrasound examination
28 days after transplantation
Study Arms (2)
Experimental group
EXPERIMENTALModified Supper Long Protocol
control group
NO INTERVENTIONlong protocol
Interventions
In Modified Supper Long Protocol, GnRH-a was used twice in mid-luteal phaes
Eligibility Criteria
You may qualify if:
- age\<36years,
- PCOS,
- Insulin resistance (HOMA-IR = fasting insulin (FINS) × fasting blood glucose (FPG) / 22.5, HOMA-IR ≥ 2.69 ）;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Reproductive & Genetic Hospital of CITIC-XIANGYA
Changsha, Hunan, 410008, China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 20, 2017
First Posted
April 4, 2017
Study Start
August 28, 2017
Primary Completion
September 15, 2018
Study Completion
September 30, 2018
Last Updated
January 11, 2022
Record last verified: 2022-01