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Predictors of Ovarian Reserve in Infertile Women

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02896023
Recruitment Status : Recruiting
First Posted : September 12, 2016
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed M Maged, MD, Cairo University

Brief Summary:

Patients will be subjected to:

A. Clinical evaluation including history and examination

B. Ultrasonographic evaluation of Ovarian Morphometry:

  • Patients will be evaluated in early follicular phase of the menstrual flow (cycle's days 1-3) by TVS scanning; using MINDRAY DP-1100 Plus Digital Machine, 7.5MHz, China, by only one examiner to avoid inter-observer variations.
  • Ovarian images will be procured in the sagittal and coronal planes and the frozen image reflecting the largest ovarian dimensions will be utilized for the measurement of ovarian length, width, and height (cm) as per standard clinical practice. Mean values of both ovaries will be used. Ovarian volume will be calculated from ellipsoid volume formula, {Ovarian volume = Ovarian Width (D1) × Ovarian Length (D2) ×Ovarian Height (D3) × 0 .523}
  • Antral follicle count will be determined for each patient

C. Laboratory Evaluation:

Blood samples will be collected in the early follicular phase. Samples will be immediately centrifuged and serum saved at -20 degrees for measurement of:

  • Anti Mullerian Hormone (AMH)
  • Follicle Stimulating Hormone (FSH)
  • Estradiol (E2) Using electro-chemiluminescence immunoassay (ELICA)

Condition or disease Intervention/treatment Phase
Ovarian Reserve Drug: human menopausal gonadotropin Phase 4

Detailed Description:

Patients will be subjected to:

A. Clinical evaluation including history and examination

B. Ultrasonographic evaluation of Ovarian Morphometry:

  • Patients will be evaluated in early follicular phase of the menstrual flow (cycle's days 1-3) by TVS scanning; using MINDRAY DP-1100 Plus Digital Machine, 7.5MHz, China, by only one examiner to avoid inter-observer variations.
  • Ovarian images will be procured in the sagittal and coronal planes and the frozen image reflecting the largest ovarian dimensions will be utilized for the measurement of ovarian length, width, and height (cm) as per standard clinical practice. Mean values of both ovaries will be used. Ovarian volume will be calculated from ellipsoid volume formula, {Ovarian volume = Ovarian Width (D1) × Ovarian Length (D2) ×Ovarian Height (D3) × 0 .523}
  • Antral follicle count will be determined for each patient

C. Laboratory Evaluation:

Blood samples will be collected in the early follicular phase. Samples will be immediately centrifuged and serum saved at -20 degrees for measurement of:

  • Anti Mullerian Hormone (AMH)
  • Follicle Stimulating Hormone (FSH)
  • Estradiol (E2) Using electro-chemiluminescence immunoassay (ELICA)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Sonographic and Laboratory Predictors of Ovarian Reserve in Infertile Women
Study Start Date : September 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Active Comparator: pregnant
women with positive pregnancy test after induction of ovulation and ICSI
Drug: human menopausal gonadotropin
Induction of ovulation followed by ICSI
Other Name: menogon

Active Comparator: Not pregnant
women with negative pregnancy test after induction of ovulation and ICSI
Drug: human menopausal gonadotropin
Induction of ovulation followed by ICSI
Other Name: menogon




Primary Outcome Measures :
  1. positive pregnancy test [ Time Frame: 14 days after embryo transfer ]


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.


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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • less than 39 years old,
  • normal menstrual cycle with a range of 24 to 35 days
  • normal seum prolactin.
  • normal uterine cavity determined by previous hysterosalpingography or hysteroscopy

Exclusion Criteria:

  • smokers
  • endometriosis
  • Women with endometriosis;
  • abnormal endocrine functions such as diabetes mellitus, thyroid disorders, and adrenal abnormalities; general diseases, those with ovarian cysts, or those who have azospermia partners.

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): NCT02896023


Contacts
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Contact: Ahmed Maged, MD 01005227404 prof.ahmedmaged@gmail.com

Locations
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Egypt
Kasr Alainy medical school Recruiting
Cairo, Egypt, 12151
Contact: Ahmed Maged, MD    01005227404    prof.ahmedmaged@gmail.com   
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ahmed Maged, MD Kasr Alainy medical school

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Responsible Party: Ahmed M Maged, MD, Assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT02896023    
Other Study ID Numbers: 154
First Posted: September 12, 2016    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Ahmed M Maged, MD, Cairo University:
predictors
ovarian reserve
infertile women
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Menotropins
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs