Predictors of Ovarian Reserve in Infertile Women

Cairo University (CU)

Status and phase: Unknown; Phase 4

Conditions: Ovarian Reserve

Treatments: Drug: human menopausal gonadotropin

Study type: Interventional

Funder types: Other

Identifiers

NCT02896023

154

Details and patient eligibility

About

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)

Full 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)

Enrollment: 100 estimated patients

Sex: Female

Ages: 20 to 39 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

100 participants in 2 patient groups

pregnant

Active Comparator group

Description:

women with positive pregnancy test after induction of ovulation and ICSI

Treatment:

Drug: human menopausal gonadotropin

Not pregnant

Active Comparator group

Description:

women with negative pregnancy test after induction of ovulation and ICSI

Treatment:

Drug: human menopausal gonadotropin