Reproductive Techniques, AssistedNCT02381821
Endometrial Volume and Sub-endometrial Vascularity as Predictors of In-vitro Fertilization Success
An observational study of Reproductive Techniques, Assisted, run by Cairo University.
Trial summary
100 patients aged 21-40 years old, diagnosed as primary or secondary infertility These patients are then assigned to receive ICSI treatment (ovulation induction, . They undergo a 3D vaginal ultrasound before treatment to measure the junctional zone thickness and followed up after treatment to determine the rate of… Read more about this study
- Who is it for?
- Ages 19 to 39 years, women only
- Conditions the study is for
- Reproductive Techniques, Assisted
- What is being tested?
- 3 D ultrasound and Doppler examination and GnRH agonist
- Type of treatment
- Injection or infusion
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2017
- 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 19 to 39 years
- Women only
- No healthy volunteers
- Adult
Study population: women with primary or secondary infertility and were scheduled for a first IVF/ICSI treatment cycle due to Pelvic Inflammatory disease, ovulatory dysfunction, tubal infertility, unexplained infertility , combined infertility with normal transvaginal ultrasound.
Who may be able to join
- A normal transvaginal ultrasound is defined as having no visible intracavitary pathology (e.g. submucous myomas, polyps or septa) and was be performed in the follicular phase of the menstrual cycle. Intramural myomas without impression or deformation of the uterine cavity were incorporated in the definition of a normal ultrasound
Who cannot join
- Exclusion criteria included Females aged above 40 years old , patients with endometriosis, abnormal endocrine functions as Diabetes mellitus, thyroid disorders and adrenal abnormalities ,general diseases, those with ovarian cysts or have azospermic partners
About this study
Official title: The Measurement of Endometrial Volume and Sub-endometrial Vascularity to Replace the Traditional Endometrial Thickness as Predictors of In-vitro Fertilization Success
100 patients aged 21-40 years old, diagnosed as primary or secondary infertility These patients are then assigned to receive ICSI treatment (ovulation induction, . They undergo a 3D vaginal ultrasound before treatment to measure the junctional zone thickness and followed up after treatment to determine the rate of implantation.
Intervention(s) All patients will undergo 3D ultrasound to measure the thickness of the junctional zone at day 21 of the cycle.
Read the detailed description
100 patients aged 21-40 years old, diagnosed as primary or secondary infertility due to the following causes of infertility; ( Pelvic Inflammatory disease, dysovulation , tubal infertility, unexplained infertility, combined infertility or due to male factor ). These patients are then assigned to receive fertility treatment (ICSI) They undergo a 3D vaginal ultrasound before treatment to measure the junctional zone thickness and followed up after treatment to determine the rate of implantation.
Intervention(s) All patients will undergo 3D ultrasound to measure the thickness of the junctional zone at day 21 of the cycle.
- Conditions
- Reproductive Techniques, Assisted
- Being tested
- 3 D ultrasound and Doppler examination, GnRH agonist
- Keywords
- junctional zone, Implantation, Intracytoplasmic sperm injection
- Medical subject headings
- Helping Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 D ultrasound and Doppler examinationOther
Endometrial thickness was measured in the longitudinal plane at the widest anteroposterior diameter with a trans-vaginal 2D ultrasound, and then 3D mode was then activated with power Doppler setting for this study standardized using a frequency at 4-9 MHZ pulse repetition frequency at 0.5KHz gain at-3.0 and wall motion filter at 1. The sub-endometrial region was considered to be within 3 mm of the originally defined myometrial-endometrial contour. The endometrial volume (EV) and 3D power Doppler indices below the endometrium were measured using the automated VOCAL™ for the 3D power Doppler histogram analysis
GnRH agonistDrug
All women received daily subcutaneous 0.1 mg triptorelin injection started from day 21) of the cycle preceding stimulation. Downregulation of the pituitary gonadotropins was confirmed after 12 days , gonadotropin (Gn) induction was started using Human menopausal gonadotropins for ovarian stimulation. The starting dose was 225 to 300 IU . Ultrasound Folliculometry was done every other day . When two or more follicles reached a minimum mean diameter of 18 mm, triggering of ovulation trigger was done using Human chorionic gonadotropin (hCG) 10,000 IU and ovum pick up was scheduled 36 hours later
| Study group | Role | What they receive |
|---|---|---|
| pregnant | women undergoing ICSI who became pregnant Receives: Other: 3 D ultrasound and Doppler examination; Drug: GnRH agonist | |
| Not pregnant | women undergoing ICSI who fail to achieve pregnancy Receives: Other: 3 D ultrasound and Doppler examination; Drug: GnRH agonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rate
Measured: 14 days after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study start1 Jan 2016
- Primary completion3 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reproductive Techniques, AssistedStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381821
- Sponsor's protocol ID
- 127
- Status last verified
- Jan 2018
- First submitted
- 3 Mar 2015
- Last updated
- 3 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Measurement of Endometrial Volume and Sub-endometrial Vascularity to Replace the Traditional Endometrial Thickness as Predictors of In-vitro Fertilization Success
- ClinicalTrials.gov ID
- NCT02381821
- Acronym / sponsor ID
- 127
- Conditions
- Reproductive Techniques, Assisted
- Keywords
- junctional zone, Implantation, Intracytoplasmic sperm injection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 3 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 6 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
100 patients aged 21-40 years old, diagnosed as primary or secondary infertility These patients are then assigned to receive ICSI treatment (ovulation induction, . They undergo a 3D vaginal ultrasound before treatment to measure the junctional zone thickness and followed up after treatment to determine the rate of implantation.
Intervention(s) All patients will undergo 3D ultrasound to measure the thickness of the junctional zone at day 21 of the cycle.
Detailed description
100 patients aged 21-40 years old, diagnosed as primary or secondary infertility due to the following causes of infertility; ( Pelvic Inflammatory disease, dysovulation , tubal infertility, unexplained infertility, combined infertility or due to male factor ). These patients are then assigned to receive fertility treatment (ICSI) They undergo a 3D vaginal ultrasound before treatment to measure the junctional zone thickness and followed up after treatment to determine the rate of implantation.
Intervention(s) All patients will undergo 3D ultrasound to measure the thickness of the junctional zone at day 21 of the cycle.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| pregnant | – | Other: 3 D ultrasound and Doppler examination, Drug: GnRH agonistwomen undergoing ICSI who became pregnant |
| Not pregnant | – | Other: 3 D ultrasound and Doppler examination, Drug: GnRH agonistwomen undergoing ICSI who fail to achieve pregnancy |
Who may qualify
- Ages
- 19 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- women with primary or secondary infertility and were scheduled for a first IVF/ICSI treatment cycle due to Pelvic Inflammatory disease, ovulatory dysfunction, tubal infertility, unexplained infertility , combined infertility with normal transvaginal ultrasound.
Key inclusion criteria (1 listed)
- A normal transvaginal ultrasound is defined as having no visible intracavitary pathology (e.g. submucous myomas, polyps or septa) and was be performed in the follicular phase of the menstrual cycle. Intramural myomas without impression or deformation of the uterine cavity were incorporated in the definition of a normal ultrasound
Key exclusion criteria (1 listed)
- Exclusion criteria included Females aged above 40 years old , patients with endometriosis, abnormal endocrine functions as Diabetes mellitus, thyroid disorders and adrenal abnormalities ,general diseases, those with ovarian cysts or have azospermic partners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3 D ultrasound and Doppler examinationEndometrial thickness was measured in the longitudinal plane at the widest anteroposterior diameter with a trans-vaginal 2D ultrasound, and then 3D mode was then activated with power Doppler setting for this study standardized using a frequency at 4-9 MHZ pulse repetition frequency at 0.5KHz gain at-3.0 and wall motion filter at 1. The sub-endometrial region was considered to be within 3 mm of the originally defined myometrial-endometrial contour. The endometrial volume (EV) and 3D power Doppler indices below the endometrium were measured using the automated VOCAL™ for the 3D power Doppler histogram analysis | Other | Not pregnant, pregnant |
| GnRH agonistAll women received daily subcutaneous 0.1 mg triptorelin injection started from day 21) of the cycle preceding stimulation. Downregulation of the pituitary gonadotropins was confirmed after 12 days , gonadotropin (Gn) induction was started using Human menopausal gonadotropins for ovarian stimulation. The starting dose was 225 to 300 IU . Ultrasound Folliculometry was done every other day . When two or more follicles reached a minimum mean diameter of 18 mm, triggering of ovulation trigger was done using Human chorionic gonadotropin (hCG) 10,000 IU and ovum pick up was scheduled 36 hours later | Drug | Not pregnant, pregnant |
Primary outcome
pregnancy rate
Time frame: 14 days after embryo transfer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
Related trials for Reproductive Techniques, Assisted
Enrolling by invitation
A Web-Based Tool to Help People With Health Conditions Make Contraceptive Decisions
Contraceptive Usage, Contraceptive Behavior
Enrolling by invitation
Multifaceted Benefits of Auricular Point Sticking for IVF Patients: Psychological Well-being, Sleep, and Treatment Outcomes
Infertility, Female, Anxiety
Recruiting
The Feasibility of taVNS on Pregnancy Outcomes of Infertility Patients Undergoing IVF
Infertility Assisted Reproductive Technology
RecruitingObservational study
Food Intake Among Women and Men in Fertility Treatment
Infertility
RecruitingObservational study
Discarded Materials Study
Infertility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Reproductive Techniques, Assisted, run by Cairo University.
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 1 inclusion and 1 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 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
pregnancy rate (time frame: 14 days after embryo transfer). 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 3 Jan 2018.