CClinicalTrials.gg
CompletedNCT03820167Updated Feb 26, 2020

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

An observational study in Polycystic Ovary Syndrome and Assisted Reproduction, sponsored by Cairo University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 38 Years. Per ClinicalTrials.gov, last updated 2020-02-26.

Sponsored by Cairo University · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
90
Ages
20 Years to 38 Years
Sex
Female
01

Study 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

Read the detailed 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)

02

Conditions studied

  • Polycystic Ovary Syndrome
  • Assisted Reproduction
03

In context

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 173 are open to participants now.

This study's enrollment of 90 is below the median of 118 across 223 observational studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 38 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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).

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

Exclusion Criteria:

  • Known medical problems as diabetes mellitus, hypertension, cardiac, hepatic or renal problem.
  • Special habits of medical importance as smoking.
  • Other endocrinopathies
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
90 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. clinical pregnancy rate

    detection of intrauterine gestational sac by transvaginal ultrasound

    Time frame: 4 weeks after embryo transfer

07

Study locations

1 site
  • Ganna IVF center
    Giza, Cairo 12111, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03820167
Lead sponsor
Cairo University
Responsible party
Ahmed M Maged, MD (Principal investigator, Cairo University) — Principal investigator
First posted
Jan 29, 2019
Start date
Jan 30, 2019
Primary completion
Dec 25, 2019
Completion
Jan 14, 2020
Last update
Feb 26, 2020

Study contacts

Ahmed Maged, MD
principal investigator · Professor

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion