Predictors of Ovarian Reserve in Infertile Women

September 20, 2019 updated by: Ahmed M Maged, MD, Cairo University

Sonographic and Laboratory Predictors of Ovarian Reserve in Infertile Women

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12151
        • Recruiting
        • Kasr Alainy medical school

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • menogon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
positive pregnancy test
Time Frame: 14 days after embryo transfer
14 days after embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

January 1, 2020

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

August 29, 2016

First Submitted That Met QC Criteria

September 6, 2016

First Posted (Estimate)

September 12, 2016

Study Record Updates

Last Update Posted (Actual)

September 23, 2019

Last Update Submitted That Met QC Criteria

September 20, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 154

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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