Mitochondrial DNA in Fresh Versus Frozen Embryo Culture Media of PCOS Women Undergoing In Vitro Fertilization

Polycystic Ovary Syndrome Clinical Trial

Official title:

Mitochondrial DNA in Fresh Versus Frozen Embryo Culture Media of Polycystic Ovarian Syndrome Patients Undergoing In Vitro Fertilization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03820167
• Other study ID #: 49
• Status: Completed
• Start date: January 30, 2019
• Est. completion date: January 14, 2020

Study information

• Verified date: February 2020
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Ninety women with PCOS candidate for ICSI were randomized to 2 groups:Group A: fresh samples of PCOS patients undergoing IVF (no= 45) and Group B: frozen samples of PCOS patients undergoing IVF (no= 45). Morphologically good embryos will be cultured in a culture dish and the supernatants will be collected freshly from culture system at day 3 and stored at -20 ̊ c until being tested. Morphologically good embryos scheduled for freezing will be cryopreserved for less than one year and thawed, the supernatant will be collected and stored at -20 ̊ c until being tested. Quantification of mtDNA in fresh and frozen culture media using qPCR technique.The template DNA prepared and the dilution standards prepared will be used for qPCR to determine the amount of MtDNA and nuclear DNA in the sample using QuantiTect SYBR Green PCR Kit

Description:

Ninety women with PCOS candidate for ICSI were randomized to 2 groups:Group A: fresh samples of PCOS patients undergoing IVF (no= 45) and Group B: frozen samples of PCOS patients undergoing IVF (no= 45). Morphologically good embryos will be cultured in a culture dish and the supernatants will be collected freshly from culture system at day 3 and stored at -20 ̊ c until being tested. Morphologically good embryos scheduled for freezing will be cryopreserved for less than one year and thawed, the supernatant will be collected and stored at -20 ̊ c until being tested. Quantification of mtDNA in fresh and frozen culture media using qPCR technique.The template DNA prepared and the dilution standards prepared will be used for qPCR to determine the amount of MtDNA and nuclear DNA in the sample using QuantiTect SYBR Green PCR Kit (Qiagen)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 14, 2020
• Est. primary completion date: December 25, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

Inclusion Criteria:

1. Age: 20-35 yrs.

2. BMI: =25.

3. PCO: diagnosed by Rotterdam criteria (at least two of the following):

1. Polycystic ovary morphology with one ovary being sufficient for diagnosis.

2. Hyperandrogenism: clinically or biochemically.

3. Anovulation or oligo-ovulation.

4. Gravidity and parity: Nulligravida.

5. Compliance: primary infertility

Exclusion Criteria:

• Known medical problems as diabetes mellitus, hypertension, cardiac, hepatic or renal problem.

• Special habits of medical importance as smoking.

• Other endocrinopathies

Related Conditions & MeSH terms

• Assisted Reproduction
• Polycystic Ovary Syndrome
• Syndrome

Locations

Country	Name	City	State
Egypt	Ganna IVF center	Giza	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pregnancy rate	detection of intrauterine gestational sac by transvaginal ultrasound	4 weeks after embryo transfer