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

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 .

Study Overview

• Status: Terminated
• Conditions: PCOS
• Intervention / Treatment: Procedure: Modified Supper Long Protocol

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410008
      • Reproductive & Genetic hospital Of CITIC-Xiangya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Modified Supper Long Protocol	Procedure: Modified Supper Long Protocol; In Modified Supper Long Protocol, GnRH-a was used twice in mid-luteal phaes
No Intervention: control group; long protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical pregnancy rate	a beating heart tube was 99 detected by ultrasound examination	28 days after transplantation

Collaborators and Investigators

• Sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2017
• Primary Completion (Actual): September 15, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: April 3, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 9, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 81501328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes