The Mechanism of Modified Utral-long Protocol in Improving Endometrial Receptivity in Patients With PCOS and IR

Sponsor
Reproductive & Genetic Hospital of CITIC-Xiangya (Other)
Overall Status
Terminated
CT.gov ID
NCT03100240
Collaborator
(none)
6
1
2
13.1
0.5

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase
  • Procedure: Modified Supper Long Protocol
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Preliminary Mechanism Study of Modified Utral-long Protocol in Improving Endometrial Receptivity in Patients With PCOS and Insulin Resistance
Actual Study Start Date :
Aug 28, 2017
Actual Primary Completion Date :
Sep 15, 2018
Actual Study Completion Date :
Sep 30, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. clinical pregnancy rate [28 days after transplantation]

    a beating heart tube was 99 detected by ultrasound examination

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 35 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Reproductive & Genetic Hospital of CITIC-XIANGYA Changsha Hunan China 410008

Sponsors and Collaborators

  • Reproductive & Genetic Hospital of CITIC-Xiangya

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Reproductive & Genetic Hospital of CITIC-Xiangya
ClinicalTrials.gov Identifier:
NCT03100240
Other Study ID Numbers:
  • 81501328
First Posted:
Apr 4, 2017
Last Update Posted:
Jan 11, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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

Study Results

No Results Posted as of Jan 11, 2022