Accuracy of Ultrasound Markers Versus Biochemical Markers in Prediction of Ovarian Response in Obese Women Undergoing IVF/ICSI Treatment
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|ClinicalTrials.gov Identifier: NCT03684824|
Recruitment Status : Not yet recruiting
First Posted : September 26, 2018
Last Update Posted : September 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Invitro Fertilization||Drug: Long luteal phase GnRH agonist protocol Drug: Gonadotropins||Not Applicable|
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. 
• 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Accuracy of Ultrasound Markers Versus Biochemical Markers in Prediction of Ovarian Response in Obese Women Undergoing IVF/ICSI Treatment|
|Estimated Study Start Date :||September 2018|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||October 2019|
100 obese patients with BMI between 30 and 35 who are undergoing IVF/ICSI treatment for infertility
Drug: Long luteal phase GnRH agonist protocol
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
Other Name: Decapeptyl 0.1mg amp
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
Other Name: Merional 75 IU/ml, IBSA, Switzerland
- number of retrieved oocytes [ Time Frame: 34 hours after HCG triggering of ovulation ]number of oocytes retrieved at day of ovum pick up
- Clinical pregnancy rate [ Time Frame: 14 days after embryo transfer ]Ultrasound detection of intrauterine gestational sac
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): NCT03684824
|Contact: Ahmed maged, MDfirstname.lastname@example.org|
|Contact: Ameer Elsherief, MDemail@example.com|
|Ameer Elsherief||Not yet recruiting|
|Contact: Ahmed Maged, MD 01005227404 firstname.lastname@example.org|
|Contact: Ameer elsherief, MD 00201001204427 email@example.com|
|Principal Investigator:||Ahmed maged||Professor|