Predictors of Ovarian Reserve in Infertile Women

NCT02896023 | Unknown Phase 4 DMC

• 1 other identifier: 154
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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)

Conditions

Ovarian Reserve

Keywords

predictors; ovarian reserve; infertile women

Outcome Measures

Primary Outcomes (1)

• positive pregnancy test

  14 days after embryo transfer

Study Arms (2)

pregnant

ACTIVE COMPARATOR

women with positive pregnancy test after induction of ovulation and ICSI

Drug: human menopausal gonadotropin

Not pregnant

ACTIVE COMPARATOR

women with negative pregnancy test after induction of ovulation and ICSI

Drug: human menopausal gonadotropin

Interventions

human menopausal gonadotropin DRUG

Induction of ovulation followed by ICSI

Also known as: menogon

Not pregnant; pregnant

Eligibility Criteria

• Age: 20 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

RECRUITING

MeSH Terms

Interventions

Menotropins

Intervention Hierarchy (Ancestors)

Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins; Biological Products; Complex Mixtures

Study Officials

• Ahmed Maged, MD

  Kasr Alainy medical school

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed Maged, MD

CONTACT

01005227404; prof.ahmedmaged@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 12, 2016
• Study Start: September 1, 2016
• Primary Completion: January 1, 2020
• Study Completion: March 1, 2020
• Last Updated: September 23, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)