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

NCT03820167 | Completed DMC

• 1 other identifier: 49
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Polycystic Ovary Syndrome; Assisted Reproduction

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy rate

  detection of intrauterine gestational sac by transvaginal ultrasound

  4 weeks after embryo transfer

Study Arms (2)

Fresh sample

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. Quantification of mtDNA in fresh and frozen culture media using qPCR technique.

Frozen embryos

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.

Eligibility Criteria

• Age: 20 Years - 38 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Detailed history taking with special emphasis on: 1. Personal history (name, age, marital state, parity, address). 2. Menstrual history (duration, cycle, amount, regularity, last menstrual period). 3. Medical history for acne and hirsutism. Clinical examination with special emphasis on: 1. Height and weight of the patients to calculate the BMI (weight in kg/ height in m2). 2. Examinationfor presence of acne and/ or hirsutism (patients with score \> 8 on Ferryman \& Gallawey score were considered as hirsute). 3. Ultrasound examination to confirm diagnosis of PCOS (Using the vaginal probe).

You may qualify if:

• Age: 20-35 yrs.
• BMI: ≤25.
• PCO: diagnosed by Rotterdam criteria (at least two of the following):
• Polycystic ovary morphology with one ovary being sufficient for diagnosis.
• Hyperandrogenism: clinically or biochemically.
• Anovulation or oligo-ovulation.
• Gravidity and parity: Nulligravida.
• Compliance: primary infertility

You may not qualify if:

• Known medical problems as diabetes mellitus, hypertension, cardiac, hepatic or renal problem.
• Special habits of medical importance as smoking.
• Other endocrinopathies

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ganna IVF center

Giza, Cairo Governorate, 12111, Egypt

Location

Biospecimen

Retention: SAMPLES WITH DNA

embryo culture media from day 3 morphologically good embryos will be collected after embryo transfer of fresh and thawed cycles. The media will be immediately frozen into sterile, PCR clean (free from DNA, DNase, RNase and PCR inhibitors) tubes and stored at - 20 C until nucleic acid purification

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Ahmed Maged, MD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 25, 2019
• First Posted: January 29, 2019
• Study Start: January 30, 2019
• Primary Completion: December 25, 2019
• Study Completion: January 14, 2020
• Last Updated: February 26, 2020

Record last verified: 2020-02

Locations

EG (1)