NCT03846388

Brief Summary

Infertility is the failure to conceive after regular unprotected sexual intercourse for one year. Primary infertility refers woman who has never conceived, and secondary infertility to one who has had a previous pregnancy.The most frequent causes for infertility are ovulatory disorder or anovulation (27-30%) , tubal factor(20-22%), abnormal semen parameters(45-50%). Unexplained infertility refers to infertile couples in whom standard investigations, including tests of ovulation, tubal patency tests and semen analysis are normal. incidence 15-17% of infertile couples. New guidelines on infertility recommend that women with unexplained infertility should be advised for expectant management for 2 years .If pregnancy is not achieved after this period In vitro fertilization Should be considered. The Fast Track and Standard Treatment trial demonstrated A shorter time to pregnancy and higher per cycle pregnancy rates for In vitro fertilization compared with treatment with oral agents or gonadotropins in Patients with unexplained infertility. Successful pregnancy after assisted reproductive technology is influenced by numerous predictors that have been investigated in the previous years. The central predictors of success are the sperm, oocyte quality and endometrial receptivity. Oocyte quality depends mainly on the age of the woman , and her ovarian reserve. Parameters most commonly studied are the woman's age , her antral follicle count , and laboratory tests including serum randomly done during the menstrual cycle levels at day 3 of the cycle.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
292

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2019

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 19, 2019

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

3 years

First QC Date

February 17, 2019

Last Update Submit

July 24, 2023

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • live birth rate

    12 months

Secondary Outcomes (1)

  • Number of fertilized oocytes

    3 days

Study Arms (2)

Patients with unexplained infertility

OTHER
Diagnostic Test: follicular stimulating hormoneDiagnostic Test: Anti-mullerian hormoneRadiation: Basal antral follicle count

patients with tubal, male factor or polycystic ovary syndrome

OTHER
Diagnostic Test: follicular stimulating hormoneDiagnostic Test: Anti-mullerian hormoneRadiation: Basal antral follicle count

Interventions

follicular stimulating hormoneDIAGNOSTIC_TEST

in the serum of our patients

Patients with unexplained infertilitypatients with tubal, male factor or polycystic ovary syndrome
Anti-mullerian hormoneDIAGNOSTIC_TEST

in the serum of our patients

Patients with unexplained infertilitypatients with tubal, male factor or polycystic ovary syndrome
Basal antral follicle countRADIATION

by ultrasound

Patients with unexplained infertilitypatients with tubal, male factor or polycystic ovary syndrome

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • in vitro fertilization treatment due to many factors including tubal, male, and unexplained factors.
  • body mass index (BMI) (18-35)kg/m2

You may not qualify if:

  • patient age less than 20 and more than 40 years.
  • body mass index less than 18 and more than 35 kg/m2.
  • period of infertility less than 2 years..
  • untreated hyperthyroidism, hypothyroidism, diabetes, hypertension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

February 17, 2019

First Posted

February 19, 2019

Study Start

February 1, 2019

Primary Completion

January 31, 2022

Study Completion

January 31, 2022

Last Updated

July 25, 2023

Record last verified: 2023-07

Locations

EG(1)