Endometrial Volume and Sub-endometrial Vascularity as Predictors of In-vitro Fertilization Success

NCT02381821 | Completed

• 1 other identifier: 127
• Study Type: observational
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Keywords

junctional zone; Implantation; Intracytoplasmic sperm injection

Outcome Measures

Primary Outcomes (1)

• pregnancy rate

  14 days after embryo transfer

Study Arms (2)

pregnant

women undergoing ICSI who became pregnant

Other: 3 D ultrasound and Doppler examination; Drug: GnRH agonist

Not pregnant

women undergoing ICSI who fail to achieve pregnancy

Other: 3 D ultrasound and Doppler examination; Drug: GnRH agonist

Interventions

3 D ultrasound and Doppler examination OTHER

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

Not pregnant; pregnant

GnRH agonist DRUG

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

Not pregnant; pregnant

Eligibility Criteria

• Age: 19 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Helping Behavior

Interventions

Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 3, 2015
• First Posted: March 6, 2015
• Study Start: January 1, 2016
• Primary Completion: December 3, 2017
• Study Completion: December 31, 2017
• Last Updated: January 3, 2018

Record last verified: 2018-01