Receptivity Assessment of Homogeneous Endometrium in Late Follicle Phase

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wen-Jie Zhu, Shen-Zhen City Maternity and Child Healthcare Hospital
ClinicalTrials.gov Identifier:
NCT01533350
First received: February 3, 2012
Last updated: February 15, 2012
Last verified: February 2012
  Purpose

Twenty eight infertile women undergoing ultrasonographic endometrial assessment in the late follicle phase, fourteen of them with homogeneous echo endometrium (group 1) and other fourteen with trilaminar endometrium (group 2), were included from our Department. The endometrial tissues were collected and Four biomarkers for endometrial receptivity and ultrastructure were assessed before and 6-7 days after ovulation.


Condition Phase
Infertile
Phase 1

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Receptivity Assessment of Homogeneous Endometrium in Late Follicle Phase of Infertile Women With Natural Cycles

Resource links provided by NLM:


Further study details as provided by Shen-Zhen City Maternity and Child Healthcare Hospital:

Primary Outcome Measures:
  • vascular endothelial growth factor(VEGF) [ Time Frame: 2 month ] [ Designated as safety issue: No ]
    The expression analyzed by Immunohistochemistry.The stainings were graded semiquantitatively and the H-score was calculated using the following equation: H-score =∑Pi (i + 1), where i = intensity of staining with a value of 1, 2 or 3 (weak,moderate or strong, respectively) and Pi is the percentage of stained epithelial cells for each intensity, varying from 0 to 100%.

  • pinopodes [ Time Frame: 2month ] [ Designated as safety issue: No ]
    The specimens were mounted, coated with platinum, and examined by using a scanning electron microscope ( S-3000N, Hitachi, Tokyo, Japan). The pinopodes morphology evaluation was defined as: no pinopodes,developing pinopodes,fully developed pinopodes and regressing pinopodes. The semi-quantitative evaluation was defined as following:- (0%), + (<20%), ++ (20-50%) and +++(>50%).

  • Ultrastructure [ Time Frame: 2 month ] [ Designated as safety issue: No ]
    Ultrastructure was observed by transmission electron microscopy

  • leukemia inhibitory factor(LIF) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    The expression analyzed by Immunohistochemistry.The stainings were graded semiquantitatively and the H-score was calculated using the following equation: H-score =∑Pi (i + 1), where i = intensity of staining with a value of 1, 2 or 3 (weak,moderate or strong, respectively) and Pi is the percentage of stained epithelial cells for each intensity, varying from 0 to 100%.

  • integrin ɑvβ3 [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    The expression analyzed by Immunohistochemistry.The stainings were graded semiquantitatively and the H-score was calculated using the following equation: H-score =∑Pi (i + 1), where i = intensity of staining with a value of 1, 2 or 3 (weak,moderate or strong, respectively) and Pi is the percentage of stained epithelial cells for each intensity, varying from 0 to 100%.

  • matrix metalloproteinase-9(MM-9) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    The expression analyzed by Immunohistochemistry.The stainings were graded semiquantitatively and the H-score was calculated using the following equation: H-score =∑Pi (i + 1), where i = intensity of staining with a value of 1, 2 or 3 (weak,moderate or strong, respectively) and Pi is the percentage of stained epithelial cells for each intensity, varying from 0 to 100%.


Biospecimen Retention:   Samples Without DNA

The specimen was divided into three parts after washing with sterilized saline, and one was fixed by 2.5% glutaraldehyde solution immediately ,then coated with palladium gold for electron microscopic examination;one was fixed by 2.5% glutaraldehyde arsenate ,then embedded in Epon for transmission electron microscopy ; one was fixed by 4% formalin, then embedded in paraffin for immunohistochemical analysis.


Enrollment: 28
Study Start Date: September 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
group1
women with a ultrasonographic homogeneous echo endometrium in the late follicle phase
group2
women with a ultrasonographic " triple-line" endometrium in the late follicle phase

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   26 Years to 39 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The mean age of the women were 31.9±3.7 years ( range, 26-39 years). The mean body mass index was 20.96±2.46 kg/m2 (range, 17.58-26.04 kg/m2).With a regular menstral cycle (25-35days) and 2-11 years infertile history, all subjects had signed the proper consent forms.

Criteria

Inclusion Criteria:

  • infertile
  • ≤ 40 years of age
  • regular menstrual cycles (25-35 days)
  • without use of an intrauterine devices or oral contraceptive at least 3 months before the study.

Exclusion Criteria:

  • polycystic ovarian syndrome (PCOS)
  • endometriosis
  • premature ovarian failure (POF)
  • an abortion within 1 year
  • pelvic inflammatory disease history
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01533350

Locations
China, Guang-Dong
Department of Reproductive Healthcare, Shen-Zhen Maternity and Child Healthcare Hospital
Shen-Zhen, Guang-Dong, China, 518000
Sponsors and Collaborators
Shen-Zhen City Maternity and Child Healthcare Hospital
Investigators
Study Chair: Wen-Jie Zhu, M.D ShenZhen Maternity and Child Healthcare Hospital
  More Information

No publications provided

Responsible Party: Wen-Jie Zhu, Clinical Professor, Shen-Zhen City Maternity and Child Healthcare Hospital
ClinicalTrials.gov Identifier: NCT01533350     History of Changes
Other Study ID Numbers: 201002089
Study First Received: February 3, 2012
Last Updated: February 15, 2012
Health Authority: China: Ministry of Health

Keywords provided by Shen-Zhen City Maternity and Child Healthcare Hospital:
Ultrasonography
late follicle phase
homogeneous endometrium
receptivity
biochemical factor
ultrastructure
endometrial echo pattern

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 16, 2014