Receptivity Assessment of Homogeneous Endometrium in Late Follicle Phase

NCT01533350 | Completed DMC

• 1 other identifier: 201002089
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infertile

Keywords

Ultrasonography; late follicle phase; homogeneous endometrium; receptivity; biochemical factor; ultrastructure; endometrial echo pattern

Outcome Measures

Primary Outcomes (6)

• vascular endothelial growth factor（VEGF)

  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%.

  2 month

• pinopodes

  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%).

  2month

• Ultrastructure

  Ultrastructure was observed by transmission electron microscopy

  2 month

• leukemia inhibitory factor(LIF)

  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%.

  2 months

• integrin ɑvβ3

  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%.

  2 months

• matrix metalloproteinase-9(MM-9)

  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%.

  2 months

Study Arms (2)

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

Eligibility Criteria

• Age: 26 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• polycystic ovarian syndrome (PCOS)
• endometriosis
• premature ovarian failure (POF)
• an abortion within 1 year
• pelvic inflammatory disease history

Sponsors & Collaborators

• Shen-Zhen City Maternity and Child Healthcare Hospital: lead

Study Sites (1)

Department of Reproductive Healthcare, Shen-Zhen Maternity and Child Healthcare Hospital

Shenzhen, Guangdong, 518000, China

Location

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.

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Wen-Jie Zhu, M.D

  Shenzhen Maternity and Child Healthcare Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 3, 2012
• First Posted: February 15, 2012
• Study Start: September 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: February 17, 2012

Record last verified: 2012-02

Locations

CN (1)