Reproductive Outcome in Assisted Conception Cycles

Infertility Clinical Trial

Official title:

Prediction Of Reproductive Outcome in Assisted Conception Cycles in Women With Unexplained Infertility

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03846388
• Other study ID #: ACC
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: January 31, 2022

Study information

• Verified date: July 2023
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 292
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility

Intervention

Diagnostic Test:
• follicular stimulating hormone
in the serum of our patients
• Anti-mullerian hormone
in the serum of our patients

Radiation:
• Basal antral follicle count
by ultrasound

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	live birth rate		12 months
Secondary	Number of fertilized oocytes		3 days