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InfertileNCT01533350

Receptivity Assessment of Homogeneous Endometrium in Late Follicle Phase

An observational study of Infertile, run by Shen-Zhen City Maternity and Child Healthcare Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 26 to 39 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infertile
How many people
28 participants
Where
1 siteChina
Study dates
Sep 2010to Jan 2012
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 26 to 39 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site
  • Department of Reproductive Healthcare, Shen-Zhen Maternity and Child Healthcare Hospital

    Shenzhen, Guangdong, 518000

Other trials in China

About this study

Official title: Receptivity Assessment of Homogeneous Endometrium in Late Follicle Phase of Infertile Women With Natural Cycles

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.

Read the detailed description

Subjects Twenty eight apparently healthy women, fourteen of them with a ultrasonographic homogeneous echo(group 1) and other fourteen with a " triple-line"(group 2) endometrium in the late follicle phase, were involved in our Department for the study between September 2010 and November 2011. The included criteria for both groups of women were ≤40 years of age, with a regular menstrual cycles (25-35 days), without use of an intrauterine devices or oral contraceptive at least 3 months before the study. Exclusion criteria were women with polycystic ovarian syndrome (PCOS), endometriosis, premature ovarian failure (POF) and an abortion within 1 year or a history of pelvic inflammatory disease. 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 menstrual cycle (25-35days) and 2-11 years infertile history, all subjects had signed the proper consent forms. The study was approved by our Institutional Ethics committee.

Ovulation monitoring The women were followed for one cycle by obtaining blood samples and urine samples. The ovulation was monitored with vaginal ultrasonography (aloka-1000, UST-985, 5 MHz transvaginal probe, aloka Co. Ltd, Tokyo, Japan). The thickness of two endometrial layers was measured. The endometrial pattern was assessed according to the classification proposed by Gonen and Casper as follows: an endometrium that was entirely homogeneously hyperechoic without a central echogenic line was considered as a homogeneous echo pattern and triple-line pattern consisted of a central hyperechoic line surrounded by two hypoechoic layers. The growth of follicles, ovulation and the development of corpus luteum were monitored by using two-plane scans. Participants identified the day of the LH surge by testing the morning urine (David ovulation test, Rubio Biotech Co. Ltd., Shantou, China). The day of the LH surge was determined in urine samples when LH surge reached its highest value on which the blood samples were collected as well. The cycle day referred to the first day of menstrual bleeding. Women who have normal ovulatory cycles with intervals of 25-35 days are expected to ovulate on day 11 at the earliest and day 21at the latest. The peripheral blood samples were obtained by vein puncture on the day of the LH surge and 6-7 days after ovulation. Blood was separated by centrifugation within 1 hour, and the serum was stored at -20℃ until the concentrations of LH, FSH, estradiol (E2) and progesterone were assayed.

Endometrial biopsy Two endometrial biopsies were performed during a single menstrual cycle in each subject. The early biopsy was performed on the pre-ovulatory day (late follicle phase) and the endometrial tissues were collected from the anterior wall of the uterine cavity. Whereas the late biopsy was performed on ovulation day +7 (midluteal phase or implantation widow phase), and the endometrial sample was collected from the posterior wall of the uterine cavity with or without dilatation of the cervix by using an endometrial curette (#4164 prebet, Genetics, pommel, Belgium). Each sample was divided into three pieces and immediately fixed. Samples for scanning electron microscopy for fixed in a solution containing 2.5% (wt/vol) glutaraldehyde, 0.5% paraformaldehyde, 0.1 mol/L of sucrose, 0.1 mol/L of sodiumcacodylate, and 3 mmol/L of calciumchloride (pH, 7.4). Samples for immunohistochemistry were fixed in 4% formalin . Samples for transmission electron microscopy was fixed by 2.5% glutaraldehyde arsenate ;

Scanning electron microscopy Samples were washed twice in a buffer containing 0.15 mol/L of sodiumcacodylate and 3 mmol/L of calcium chloride (PH, 7.4) and once in distilled water. The specimens were dehydrated first in increasing concentrations of ethanol (70%,95%,and 99.5%) and then in acetone; they were dried in a critical-point dryer by using carbon dioxide. The specimens were mounted, coated with platinum, and examined by using a scanning electron microscope ( S-3000N, Hitachi, Tokyo, Japan). The developmental phase of the pinopode were classified. Because the pinopodes on the endometrial surface do not develop at exactly the same time the pinopodes were not evenly distributed over the endometrial surface, thus, in our study, we examined five fields each biopsy sample and analyzed the development and distribution of pinopodes. The 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%).

Immunohistochemistry 56 biopsy samples of 28 patients were used for immunohistochemical analysis. For LIF, integrin αv, VEGF and MMP-9 studies 4 um paraffin-embedded sections were deparaffinized 20 min in acetone at 70℃. Endogenous peroxidase was blocked with 3% H2O2 for 10 min. Antigen retrieval was boiling by heating for 5 min in 0.01 M citrate buffer at pH 6.0,and then the sections were incubated overnight at 4℃ with the specific antibodies which were diluted at 1:50. The antibodies used in this study were polyclonal antibodies (PAB) LIF, integrin αv, VEGF and MMP-9 (BA 1239, BA0957,BA0407 and BA0573, Booster Co Ltd, Wuhan, China). The sections were rinsed in phosphate-buffered saline (PBS), blocked with 10% normal goat serum for 30 min and then incubated with goat anti-rabbit biotinylated immunoglobulins (IgG)(SV0002, Booster Co Ltd, Wuhan, China) at 37℃ for 30 min. For integrin β3 study, the sections were incubated with 3% hydrogen peroxide for 10 min after hot repair of antigen by boiling at 95℃ of 0.01M citrate buffer(pH6.0), then incubated with polyclonal antibodies integrin β3 (sc-6626, santa, USA) diluted at 1:100 overnight at 4℃. Polymer Helper (PV-9003, Zhong-Shang Co Ltd, Beijing, China) was added at room temperature and with a interval of 20 min, Poly Peroxidase-anti-goat IgG (PV-9003, Zhong-Shang Co Ltd, Beijing, China) was added. The slides were then washed in PBS and colored by 3,3-diaminobenzidine in H2O2 (DAB, vitrogen, California, USA). The sections were finally washed in water. In every case a negative control was performed by omission of incubation with the primary specific antibody. The reactivity of each polyclonal antibody with endometrial glands and surface epithelium, stromal cells was assessed. Staining was evaluated semiquantitatively by using a grading system. Staining intensity and the number of stained cells were graded on a scale of 0=no staining, +/- = few stained cells, + = faint staining, ++ = moderate staining, and +++ = strong staining. The formula of H-score=ΣPi(i+1) was used to calculation. One observer who was blinded to identify of the slides performed all the assessments. After completion of the study, the same observer reexamined the slides to ensure reproducibility of the semiquantitative assessment.

Transmission electron microscopy Specimens for transmission electron microscopy were fixed in 2.5% glutaraldehyde in PBS (pH 7.4) and post-fixed in 1% osmium tetroxide. After dehydration in a graded ethanol series, specimens were placed in propylene oxide and embedded in Epon, stained with uranyl acetate and lead citrate and examined in transmission electron microscope .

Statistical Analysis The Statistics Package for Social Science (SPSS 13.0; SPSS Inc., Chicago, IL) was used for statistical analyses. The mean±S.D was evaluated using analysis of student's t-test ,ranked data was analyzed with the Rank Sum Test (Mann-Whitney test) and qualitative data was analyzed with chi-square test . Statistical significance was set at P<0.05(two tailed).

Conditions
Infertile
Keywords
Ultrasonography, late follicle phase, homogeneous endometrium, receptivity, biochemical factor, ultrastructure, endometrial echo pattern
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01533350
Study groupRoleWhat they receive
group1women with a ultrasonographic homogeneous echo endometrium in the late follicle phase
group2women with a ultrasonographic " triple-line" endometrium in the late follicle phase

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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%.

    Measured: 2 month

  2. 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%).

    Measured: 2month

  3. Ultrastructure

    Ultrastructure was observed by transmission electron microscopy

    Measured: 2 month

  4. 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%.

    Measured: 2 months

  5. 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%.

    Measured: 2 months

  6. 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%.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Feb 2012 (estimated)
  2. Study startSep 2010
  3. Primary completionJan 2012
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01533350
Sponsor's protocol ID
201002089
Status last verified
Feb 2012
First submitted
3 Feb 2012
Last updated
17 Feb 2012
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Infertile, run by Shen-Zhen City Maternity and Child Healthcare Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

vascular endothelial growth factor(VEGF) (time frame: 2 month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2012.

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