Predictors of Ovarian Reserve in Infertile Women

NCT ID: NCT02896023

Last Updated: 2019-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2020-03-31

Brief Summary

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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)

Detailed Description

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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)

Conditions

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Ovarian Reserve

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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pregnant

women with positive pregnancy test after induction of ovulation and ICSI

Group Type ACTIVE_COMPARATOR

human menopausal gonadotropin

Intervention Type DRUG

Induction of ovulation followed by ICSI

Not pregnant

women with negative pregnancy test after induction of ovulation and ICSI

Group Type ACTIVE_COMPARATOR

human menopausal gonadotropin

Intervention Type DRUG

Induction of ovulation followed by ICSI

Interventions

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human menopausal gonadotropin

Induction of ovulation followed by ICSI

Intervention Type DRUG

Other Intervention Names

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menogon

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed M Maged, MD

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Maged, MD

Role: PRINCIPAL_INVESTIGATOR

Kasr Alainy medical school

Locations

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Kasr Alainy medical school

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed Maged, MD

Role: CONTACT

01005227404

Facility Contacts

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Ahmed Maged, MD

Role: primary

01005227404

Other Identifiers

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154

Identifier Type: -

Identifier Source: org_study_id

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