Biomarkers predictive of embryo quality and assisted reproductive treatment outcomes

Not Applicable

Recruiting

• Conditions: Reproductive health; Assisted reproduction; Subfertility; Infertility; Reproductive Health and Childbirth - Fertility including in vitro fertilisation

• Registration Number: ACTRN12621001405808
• Lead Sponsor: Drop Bio Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-18
• Last Update Posted: 3 October 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 400

Inclusion Criteria

1. Seeking and undergoing fertility treatment at one of Virtus Health’s three major Sydney clinics (Alexandria, Greenwich and Westmead)
2. Female
3. 18 - 42 years of age
4. Antagonist treatment protocol
5. Autologous oocyte
6. In vitro fertilisation (IVF)
7. Intracytoplasmic sperm injection (ICSI)
8. Scheduled for a blood collection within the first 72h of menses

Exclusion Criteria

1. Male-factor infertility defined by Australia and New Zealand Assisted Reproduction Database (ANZARD) in patient history
2. Undertaking assisted reproductive therapy (ART) and oocyte or embryo freeze all for fertility preservation
3. Body Mass Index greater than 35kg.m2 or less than 18.5kg.m2
4. Currently receiving steroid based therapy in the last two weeks
5. Recent antimicrobial treatment n the last two weeks
6. Recent iron infusion OR infusion/transfusion based therapy n the last 12 weeks
7. Genetic disorder(s) diagnosis
8. Any past history of chemotherapy
9. Autoimmune disorder(s) diagnosis
10. Recent surgery within n the last 12 weeks
11. Acute illness, such as an infection, within the last two weeks
12. Renal impairment diagnosis
13. Liver dysfunction diagnosis and or significant hypoalbuminaemic state

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Pregnancy, rate per embryo transfer. <br>Clinical pregnancy is determined by fetal heartbeat at ultrasound and number of embryos transferred are both obtained from patient records.[Six weeks gestation]