search
Back to results

Reproductive Outcome in Assisted Conception Cycles

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
follicular stimulating hormone
Anti-mullerian hormone
Basal antral follicle count
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infertility

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria

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

Sites / Locations

  • Assiut university

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patients with unexplained infertility

patients with tubal, male factor or polycystic ovary syndrome

Arm Description

Outcomes

Primary Outcome Measures

live birth rate

Secondary Outcome Measures

Number of fertilized oocytes

Full Information

First Posted
February 17, 2019
Last Updated
July 24, 2023
Sponsor
Assiut University
search

1. Study Identification

Unique Protocol Identification Number
NCT03846388
Brief Title
Reproductive Outcome in Assisted Conception Cycles
Official Title
Prediction Of Reproductive Outcome in Assisted Conception Cycles in Women With Unexplained Infertility
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
292 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with unexplained infertility
Arm Type
Other
Arm Title
patients with tubal, male factor or polycystic ovary syndrome
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
follicular stimulating hormone
Intervention Description
in the serum of our patients
Intervention Type
Diagnostic Test
Intervention Name(s)
Anti-mullerian hormone
Intervention Description
in the serum of our patients
Intervention Type
Radiation
Intervention Name(s)
Basal antral follicle count
Intervention Description
by ultrasound
Primary Outcome Measure Information:
Title
live birth rate
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of fertilized oocytes
Time Frame
3 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: in vitro fertilization treatment due to many factors including tubal, male, and unexplained factors. body mass index (BMI) (18-35)kg/m2 Exclusion Criteria 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.
Facility Information:
Facility Name
Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Reproductive Outcome in Assisted Conception Cycles

We'll reach out to this number within 24 hrs