Predictors of Ovarian Reserve in Infertile Women

Phase 4

• Conditions: Ovarian Reserve
• Interventions: Drug: human menopausal gonadotropin

• Registration Number: NCT02896023
• Lead Sponsor: 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)

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 Timeline

• Study First Submitted: 2016-08-29
• Study Start: 2016-09
• Study First Submitted QC: 2016-09-06
• Study First Posted: 2016-09-12
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-20
• Last Update Posted: 2019-09-23
• Primary Completion: 2020-01
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Not pregnant	human menopausal gonadotropin	women with negative pregnancy test after induction of ovulation and ICSI
pregnant	human menopausal gonadotropin	women with positive pregnancy test after induction of ovulation and ICSI

Primary Outcome Measures

Name	Time	Method
positive pregnancy test	14 days after embryo transfer

Trial Locations

Locations (1)

Kasr Alainy medical school; 🇪🇬 Cairo, Egypt