Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03684824
Recruitment Status : Unknown
Verified September 2018 by Ahmed Maged, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : September 26, 2018
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Maged, Cairo University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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

Condition or disease Intervention/treatment Phase
Invitro Fertilization Drug: Long luteal phase GnRH agonist protocol Drug: Gonadotropins Not Applicable

Detailed 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
obese group
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

Drug: Gonadotropins
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. number of retrieved oocytes [ Time Frame: 34 hours after HCG triggering of ovulation ]
    number of oocytes retrieved at day of ovum pick up


Secondary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: 14 days after embryo transfer ]
    Ultrasound detection of intrauterine gestational sac


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women between 20 and 35 age.
  • BMI: 30 -35

Exclusion Criteria:

  • Women less than 19 years or more than 35 years.
  • BMI less than 30 or more than 35
  • Women with Hypothyroidism.
  • Women receiving any treatment may reduce their fertility e.g: chemotherapy.
  • Women with recurrent IVF failure
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Ahmed maged, MD +2001005227404 prof.ahmedmaged@gmail.com
Contact: Ameer Elsherief, MD ameerelsherief@yahoo.com

Locations
Layout table for location information
Egypt
Ameer Elsherief
Minya, Egypt
Contact: Ahmed Maged, MD    01005227404    prof.ahmedmaged@gmail.com   
Contact: Ameer elsherief, MD    00201001204427    ameerelsherief@yahoo.com   
Sponsors and Collaborators
Cairo University
Investigators
Layout table for investigator information
Principal Investigator: Ahmed maged Professor
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Ahmed Maged, professor, Cairo University
ClinicalTrials.gov Identifier: NCT03684824    
Other Study ID Numbers: 39
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Triptorelin Pamoate
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
 Physiological Effects of Drugs
Contraceptive Agents, Hormonal
Antineoplastic Agents, Hormonal
Antineoplastic Agents