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Assessment of Endometrial Thickness & Subendometrial Perfusion by 3D Power Doppler in Women With Unexplained Infertility and PCOS.

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ClinicalTrials.gov Identifier: NCT03397693
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
Moustafa Gadalla, Assiut University

Brief Summary:
Evaluation of the endometrial thickness and subendometrial blood perfusion in women with unexplained infertility and PCOS using 3D Power Doppler and uterine artery Doppler in comparison to a control group.

Condition or disease
Unexplained Infertility PCOS Endometrial Thickness

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 185 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Assessment of Endometrial Thickness & Subendometrial Perfusion by 3D Power Doppler in Women With Unexplained Infertility and PCOS.
Estimated Study Start Date : June 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Group/Cohort
1
Women with unexplained infertiltiy with no treatment given
2
Women with Poly Cystic Ovary Syndrome (PCOS) who are being treated with different drugs of ovulation induction.
3
Control fertile women with no treatment given.



Primary Outcome Measures :
  1. Endometrial thickness and 3d Power Doppler indices of subendometrium [ Time Frame: Mid luteal phase defined as (Day 20-23) of the menstrual cycle for each patient ]
    Thickest part of the endometrium in sagittal plane by transvaginal ultrasound

  2. Clinical pregnancy [ Time Frame: After 6 weeks from last menstrual period and positive pregnancy test ]
    Visualization of one or more gestational sacs by transvaginal ultrasound


Secondary Outcome Measures :
  1. 2D Doppler indices of both uterine arteries [ Time Frame: Mid luteal phase defined as (Day 20-23) of the menstrual cycle for each patient ]
    S/D, RI, PI of uterine arteries.

  2. Endometrial volume [ Time Frame: Mid luteal phase defined as (Day 20-23) of the menstrual cycle for each patient ]
    Using VOCAL software during transvaginal ultrasound examination



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Sampling Method:   Probability Sample
Study Population
  1. unexplained infertility (normal regular menstrual cycles and normal pelvic examination, evidence of ovulation by TV/US and normal mid-luteal serum progesterone, normal semen analysis of the husband according to WHO guidlines2010 (25), and evidence of tubal patency and normal uterine cavity by HSG and/or laparoscopy).
  2. Women with PCOS according to Rotterdam ASRM/ESHRE criteria(26)
  3. Healthy fertile women (Multipara with last delivery since ≥ 2 years with no history of abortions and not on contraception (hormonal or IUD)).
Criteria

Inclusion Criteria:

  • • Inclusion criteria of study group (1):

    1. Women with primary or secondary infertility for more than 1 year due to unexplained infertility (normal regular menstrual cycles and normal pelvic examination, evidence of ovulation by TV/US and normal mid-luteal serum progesterone, normal semen analysis of the husband according to WHO guidlines2010 (25), and evidence of tubal patency and normal uterine cavity by HSG and/or laparoscopy).
    2. Women with PCOS according to Rotterdam ASRM/ESHRE criteria(26) • Inclusion criteria for control group (2):
    1. Women with no history of menstrual dysfunction or subfertility.
    2. Normal regular cycles and normal pelvic examination.
    3. Multipara with last delivery since ≥ 2 years with no history of abortions and not on contraception (hormonal or IUD).

Exclusion Criteria:

  • • Exclusion criteria of both groups:

    1. History of pelvic surgery or pelvic inflammatory disease.
    2. Current hormonal contraception.
    3. On IUD.
    4. History of or clinical features suggesting endometriosis or pelvic pathology like uterine fibroid and ovarian cyst.
    5. General medical disorders (e.g. D.M), smoking and lactation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397693


Locations
Egypt
Department of Obstetrics and Gynecology, School of Medicine, Assiut University Recruiting
Assiut, Egypt, 71500
Contact: Moustafa Gadalla, Assistant lecturer    +201029711066    moustafaabdelhafez@yahoo.com   
Principal Investigator: Moustafa Gadalla, Assistant lecturer         
Principal Investigator: Ali Elsaman, Professor         
Principal Investigator: Sayed Abdulhameid, Professor         
Principal Investigator: Alaa Ismail, Professor         
Sponsors and Collaborators
Assiut University

Responsible Party: Moustafa Gadalla, Dr Moustafa Gadalla, Assistant lecturer and specialist of obstetrics and gynecology in school of medicine in Assiut University in Egypt, Assiut University
ClinicalTrials.gov Identifier: NCT03397693     History of Changes
Other Study ID Numbers: 17200152
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Moustafa Gadalla, Assiut University:
PCOS
Unexplained infertiltiy
3D Power Doppler
Endometrial thickness
Subendometrial blood perfusion

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