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

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ClinicalTrials.gov Identifier: NCT03820167
Recruitment Status : Completed
First Posted : January 29, 2019
Last Update Posted : February 26, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed M Maged, MD, Cairo University

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

Condition or disease
Polycystic Ovary Syndrome Assisted Reproduction

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)

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Study Type : Observational
Actual Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Mitochondrial DNA in Fresh Versus Frozen Embryo Culture Media of Polycystic Ovarian Syndrome Patients Undergoing In Vitro Fertilization
Actual Study Start Date : January 30, 2019
Actual Primary Completion Date : December 25, 2019
Actual Study Completion Date : January 14, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. clinical pregnancy rate [ Time Frame: 4 weeks after embryo transfer ]
    detection of intrauterine gestational sac by transvaginal ultrasound


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


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
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).
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03820167


Locations
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Egypt
Ganna IVF center
Giza, Cairo, Egypt, 12111
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ahmed Maged, MD Professor
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Responsible Party: Ahmed M Maged, MD, Principal investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03820167    
Other Study ID Numbers: 49
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases