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

R

Reproductive & Genetic Hospital of CITIC-Xiangya

Status

Terminated

Conditions

PCOS

Treatments

Procedure: Modified Supper Long Protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT03100240
81501328

Details and patient eligibility

About

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 .

Full 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.

Enrollment

6 patients

Sex

Female

Ages

20 to 35 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

6 participants in 2 patient groups

Experimental group
Experimental group
Description:
Modified Supper Long Protocol
Treatment:
Procedure: Modified Supper Long Protocol
control group
No Intervention group
Description:
long protocol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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