Accuracy of Ultrasound Markers Versus Biochemical Markers in Prediction of

Status Not yet recruiting

Clinical Trial Summary

After detailed history and examination, long luteal protocol will be used for controlled ovarian hyperstimulation, so the patient will start treatment in day 21 of previous cycle, then in the early follicular phase of next cycle day 2-3 will have transvaginal sonography for assessment of total ovarian volume and number of antral follicles measuring (2-10mm) in diameter. On the same day a venous sample will be obtained for the measurement of AMH, basal FSH and E2 levels

Clinical Trial Description

After detailed history and examination,A transvaginal ultrasound will be done using a transvaginal transducer with 7.5 MHz.

Each ovary will be measured in 3 planes maximal longitudinal, antero-posterior and transverse diameters, D1, D2 and D3 respectively. And ovarian volume will be calculated using the ellipsoid formula:

V = D1× D2 × D3 × 0.523 The volume of both ovaries will be added for the total basal ovarian volume (BOV).

The mean diameter of the antral follicles will be used by measuring the diameter of the follicle in two perpendicular directions.

The total AFC is calculated by counting the follicles with mean diameter 2-10mm in both ovaries.

• Ovulation induction protocol:- Long luteal phase agonist protocol will be used in all patients. Pituitary suppression will be done using daily subcutaneous injection of triptorelin acetate ( Decapeptyl 0.1mg, Ferring, Germany). Starting from day 21 of the previous cycle.

Controlled ovarian hyperstimulation will be done using daily intramuscular injection of highly purified Human Menopausal Gonadotrophins (Merional 75 IU/ml, IBSA, Switzerland), starting from day 2-3 of the stimulated cycle, total dose will be adjusted according to patient response.

Induction of oocyte maturation will be done using human chorionic gonadotrophins as an intramuscular injection of 10000 IU hCG (Choriomon 5000 i.u, IBSA, Switzerland). When there was sufficient ovarian response that defined as the presence of three or more ovarian follicles with mean diameter 18mm or more. [15]

• Monitoring of the cycle: The response to ovarian stimulation will be monitored by serial transvaginal ultrasound starting on day 6 of stimulation and onwards assessing the ovarian follicles number and diameter, as well as serum E2 level as indicated.

• Oocyte Retriveal: Oocyte retrieval will done (34-36 hours) after hCG injection, by transvaginal guided vacuumed oocyte aspiration using double lumen oocyte aspiration needle for flushing of the follicles.

• Measurement of FSH and E2 Levels: A blood sample will be withdrawn on day (2 - 3) of the menstrual cycle in which the patient will undergo stimulation, for estimation the basal FSH (mIU/ml) , E2 (pg/ml) and AMH (ng/ml) levels.

Both FSH and E2 will be tested using VIDAS equipment, both the FSH and E2 were measured by automated quantitative testing, using the ELFA technique (Enzyme Linked Fluorescent Assay). In the same way, AMH will be tested by Beckman Coulter, using GenII ELISA, USA. ;

Study Design

Related Conditions & MeSH terms

Invitro Fertilization

Clinical Trial Details

NCT number	NCT03684824
Study type	Interventional
Source	Cairo University
Contact	Ahmed maged, MD
Phone	+2001005227404
Email	prof.ahmedmaged@gmail.com
Status	Not yet recruiting
Phase	N/A
Start date	September 2018
Completion date	October 2019

View Details

See also
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Completed	`NCT02764255` - Embryoscope and Reproductive Outcome	N/A
Recruiting	`NCT02084940` - Long Acting GnRH Antagonist in PCOS Women Undergoing IVF	N/A
Completed	`NCT02674178` - FSH/LH Ratio as a Predictor of IVF Outcome in Young and Older Women	Phase 4
Completed	`NCT01576991` - Telomeres and Reproduction in Women	N/A
Recruiting	`NCT03457233` - The Impact of Body Weight on Reproductive Outcomes in Poor Ovarian Responders in ICSI Cycles	N/A
Completed	`NCT02660125` - Endometrial Injury and Implantation Rates Before First ICSI Cycle	N/A
Completed	`NCT03402620` - Poor Responders Infertile Patients -A Great Clinical Challenge	N/A
Completed	`NCT03831542` - Effect of Follicular Flushing in Patients With Mono-follicular Growth Undergoing In Vitro Fertilization
Not yet recruiting	`NCT03263299` - Value of Cabergoline and Low Dose Aspirin in Poor Responders Undergoing ICSI-ET With GnRH Agonist Flare-Up-Protocol	Phase 4
Completed	`NCT03118830` - Long Protocol and Freeze All Embryos vs Antagonist Protocol With Fresh Embryo Transfer in PCOS Patients Undergoing ICSI	Phase 4
Recruiting	`NCT02383394` - Factors Associated With Pregnancy Loss in IVF Women	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Accuracy of Ultrasound Markers Versus Biochemical Markers in Prediction of Ovarian Response in Obese Women Undergoing IVF/ICSI Treatment

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms