Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03397693
Other study ID # 17200152
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 3, 2018
Est. completion date May 20, 2019

Study information

Verified date June 2019
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

• Background Infertility is a frustrating disease that affects many couples around the world. Although there are many etiologies responsible for infertility , there are about 15-30 % of couples who suffer from what is called "Unexplained Infertility". About 25% of infertility is caused by ovulatory disorders. The World Health Organization (WHO) classifies these ovulatory disorders into 3 groups. Group II includes women with hypothalamic-pituitary-ovarian dysfunction (predominately polycystic ovary syndrome (PCOS)) In unexplained infertility, basic investigations that are done first to reveal the cause of infertility reveal normal findings. These basic investigations should provide evidence of ovulation, adequate sperm production and patency of the fallopian tubes.

However, with these routine investigations and even with other more sophisticated investigations it is hard to reveal all possible abnormalities. Therefore, unexplained infertility appears to represent either the lower extreme of the normal distribution of fertility, or it arises from a defect in fecundity that cannot be detected by the routine infertility evaluation. Couples with unexplained infertility suffer from both diminished and delayed fecundity.

Due to absence of specific abnormality in cases with unexplained infertility, the management is usually empiric. Suggested treatment regimens include intrauterine insemination (IUI), ovulation induction with oral or injectable medications, combination of IUI with ovulation induction, and assisted reproductive technologies (ART).

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder affecting young women of reproductive age with the prevalence ranging between 2% to 18% according to different population and diagnostic criteria. It has been suggested that uterine blood flow is impaired in women with PCOS.

Ovulation induction (OI) is by far the most commonly used treatment for women with WHO group II anovulation and clomiphene citrate (CC) has historically been the most used drug In many fertility guidelines, CC is recommended as the first-line treatment for women with group II anovulation or PCOS who wish to conceive. However, other guidelines recommend both CC and letrozole as first-line treatments. It is hypothesized that CC resistance and failure are related to anti-estrogenic effects of CC on the endometrium, cervical mucus, and uterine blood flow.

Each month, the human endometrium undergoes a series of distinct cyclical changes in preparation to receive the developing blastocyst. Such changes necessitate well-controlled dynamic remodeling of the endometrial microvasculature through the processes of angiogenesis and arteriogenesis. Abnormalities of endometrial blood perfusion have been associated with several menstrual disorders including: dysmenorrhea, menorrhagia, intermenstrual bleeding and endometriosis. So, adequate blood perfusion of the endometrium is considered an important factor for what is called "endometrial receptivity". So it is possible that women with unexplained infertility have decreased uterine and endometrial blood perfusion.

Following implantation, there are certain changes that occur in the endometrium and its vasculature. These changes occur simultaneously with the trophoblastic invasion of the spiral arteries, and any kind of abnormalities in these changes has been associated with complications during pregnancy like: recurrent miscarriage, preterm delivery, intrauterine growth restriction and pre-eclampsia. So, the condition of the endometrium is very essential for successful implantation of the gestational sac and one of the most important factors affecting the endometrium is its blood perfusion.

The usual methods of assessment of endometrium like measurement of its thickness and description of its appearance are considered poor indicators of successful implantation and pregnancy.Other tools of investigations include: uterine artery Doppler and pulsed wave Doppler. It was found that information revealed from uterine artery Doppler alone may not represent the perfusion of the endometrium. Also, pulsed wave Doppler is used to examine the smaller downstream radial and spiral arteries and this reveals information from single vessels rather than from the endometrium as a whole. On the other hand, 3D Power Doppler is claimed to be the best investigatory tool for the study of endometrial blood perfusion as it is more sensitive to low flow and thus overcomes the problems of angle dependence and background noise associated with both color and pulsed wave Doppler. In addition, whereas color Doppler provides qualitative information, the 3D Power Doppler signal can be subsequently analyzed to produce quantitative information through one of several computer software packages.

• Hypothesis: Null hypothesis: There is no difference in endometrial thickness, 2D and 3D Power Doppler indices between normal fertile women, women with unexplained infertility and women with PCOS.

Alternative hypothesis: There is a difference in endometrial thickness, 2D and 3D Power Doppler indices between above-mentioned groups.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date May 20, 2019
Est. primary completion date April 20, 2019
Accepts healthy volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- • Inclusion criteria of study group (1&2):

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/or 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.

Study Design


Locations

Country Name City State
Egypt Department of Obstetrics and Gynecology, School of Medicine, Assiut University Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Endometrial thickness Thickest part of the endometrium in sagittal plane by transvaginal ultrasound Mid luteal phase defined as (Day 20-24) of the menstrual cycle for each patient
Primary Endometrial and sub-endometrial blood perfusion expressed as VI, FI VFI. Endometrial and sub-endometrial blood perfusion by 3D Power Doppler Mid luteal phase defined as (Day 20-24) of the menstrual cycle for each patient
Primary 2D Doppler indices of both uterine arteries RI, PI of uterine arteries. Mid luteal phase defined as (Day 20-24) of the menstrual cycle for each patient
Secondary Demographic characteristics of included women. Demographic characteristics of included women. Mid luteal phase defined as (Day 20-24) of the menstrual cycle for each patient
Secondary Endometrial volume Using VOCAL software during transvaginal ultrasound examination Mid luteal phase defined as (Day 20-24) of the menstrual cycle for each patient
Secondary Uterine volume Using VOCAL software during transvaginal ultrasound examination Mid luteal phase defined as (Day 20-24) of the menstrual cycle for each patient
See also
  Status Clinical Trial Phase
Recruiting NCT06101147 - Effect of Vitamin D Supplementation on Testosterone Level in Women With Polycystic Ovary Syndrome Phase 2
Completed NCT02037672 - PDE-4 Inhibitor Roflumilast and Polycystic Ovary Syndrome Phase 4
Completed NCT01833949 - Unilateral Laparoscopic Diathermy Adjusted to Ovarian Volume N/A
Completed NCT03608813 - Myo-inositol, D-chiro-inositol and Glucomannan in PCOS
Not yet recruiting NCT05298657 - The Angiotensin-Melatonin Axis in Poor and Hyper Responders for IVF Treatment
Completed NCT05951309 - Myoinositol Treatment and Asprosin Levels in PCOS N/A
Enrolling by invitation NCT04485403 - The Effect of Ibuprofen on Women With PCOS. Phase 2
Not yet recruiting NCT03978013 - Pomegranate Juice Effect on Oxidative Stress in Infertile Women During IVF Treatment N/A
Recruiting NCT03767569 - Myo-inositol as Pretreatment in Hyperandrogenic PCOS Patients Phase 3
Completed NCT05843955 - Non-alcoholic Fatty Liver Disease in Women With Polycystic Ovary Syndrome
Recruiting NCT05971849 - Dampening the Reproductive Axis With Continuous Kisspeptin Phase 1
Recruiting NCT04597099 - Androgen Blockade and Progesterone Augmentation of Gonadotropin Secretion Early Phase 1
Active, not recruiting NCT05206448 - Randomized Controlled Trial of Combined Letrozole and Clomid (CLC II) Versus Letrozole Alone for Women With Anovulation Phase 4
Recruiting NCT02358421 - Prediction of High Ovarian Response After Assisted Reproductive Techniques N/A
Completed NCT04113889 - Effects of Triple Drug Cocktail Therapy on Metabolic, Endocrine Alterations and Perceived Stress in Patients With Poly Cystic Ovary Syndrome Phase 2
Completed NCT04562883 - Single vs. Group CAPA-IVM Culture of Cumulus-oocyte Complexes N/A
Recruiting NCT03264638 - A Clinical and Biological Research of Combined Chinese and Western Medicine in the Treatment of PCOS Phase 2
Completed NCT00594217 - Determining How Quickly Progesterone Slows LH Pulse Frequency Phase 1
Recruiting NCT02024984 - Luteal Phase Versus Follicular Phase Administration of Clomiphene Citrate in PCOS, A Randomized Controlled Trial Phase 1
Completed NCT01709942 - Use of Degarelix in Controlled Ovarian Hyperstimulation (COH) Protocol for Women With PoliCystic Ovarian Syndrome (PCOS) Phase 3