Female InfertilityNCT03565107
Characterization of Methylation Pattern in Human Germ Cells of Patients Undergoing ICSI Treatment
An observational study of Female Infertility and Gene Deregulation, run by Infertility Treatment Center Dortmund at 1 site in Germany.
Trial summary
There is increasing evidence that exposure to environmental factors in early development is associated with an increased risk of metabolic and other common diseases. These increased disease risks are likely due to environmental-induced epigenetic changes leading to dysregulation of genes and signaling cascades. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Infertility, Gene Deregulation
- How many people
- 156 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jul 2018to 31 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: female patients seeking ICSI treatment because of male subfertility
Who may be able to join
- healthy females without sterility factors
Who cannot join
- Endometriosis
- Polycystic ovary syndrome (PCO)
- Neoplasia (ovary, Uterus, breast)
- Anti-Müllerian hormone (AMH) <1 ng/ml
Trial locations and contacts
1 site in 1 country.
Germany1 site
Infertility treatment center Dortmund
Dortmund, North Rhine-Westphalia, 44135
About this study
Official title: Characterization of Methylation Pattern in Human Germ Cells of Patients with the Desire to Have Children Undergoing Intracytoplasmic Sperm Injection Treatment
There is increasing evidence that exposure to environmental factors in early development is associated with an increased risk of metabolic and other common diseases. These increased disease risks are likely due to environmental-induced epigenetic changes leading to dysregulation of genes and signaling cascades. The best studied epigenetic modification in this context is DNA methylation. Preliminary studies have already shown that an increased father age or intracytoplasmic sperm injection affects methylation pattern in sperm or umbilical cord blood of children. Unlike sperm, less is known about the methylation of human oocytes and their susceptibility to environmental factors. The aim of this study is to analyze the methylation pattern of immature oocytes of women with decreased fertility. Based on the results of a large number of oocytes from different women, risk assessments could be made for individual factors such as the age of the patient, as well as correlations between the occurrence of changes in gene expression and the unfulfilled desire to have children. In addition, the methylation patterns in sperm from 20 patients are to be examined as reference patterns.
Read the detailed description
Although more than five million children have been conceived worldwide through Assisted Reproduction Techniques (ARTs), little is known about potential effects of ART in later life. So far, the focus of reproductive research is based on the success rate of infertility treatment. There is increasing evidence that exposure to environmental substances, age of the patient or in vitro culture conditions in early development is associated with a life-long increased risk of metabolic and other common diseases. These increased disease risks are likely due to environmental-induced epigenetic changes leading to dysregulation of genes and signaling cascades. These include Beckwith-Wiedemann and Angelman syndrome.
The best studied epigenetic modification in this context is DNA methylation, which regulates the gene expression in a temporally and highly coordinated manner. Preliminary studies have already shown that an increased father age influences the pattern of methylation in the sperm and umbilical cord blood of children. Moreover, intracytoplasmic sperm injection (ICSI) also leaves epigenetic signatures in umbilical cord blood. Unlike sperm, little is known about the methylation of human oocytes and their susceptibility to environmental factors. The main reason for this is the difficulty of collecting human oocytes in sufficient numbers for genome-wide analysis. The aim of this study is to analyze the methylation pattern of immature oocytes, which are not suitable for further ICSI treatment, of women with decreased fertility. The products of gene expression and also the methylation of the DNA itself can be investigated using newly developed DNA sequencing methods. Based on the results of a large number of oocytes from different women, risk assessments could be made for individual factors such as the age of the patient, as well as correlations between the occurrence of changes in gene expression and the unfulfilled desire to have children. In addition, the methylation patterns in sperms from 20 patients are to be examined as reference.
- Conditions
- Female Infertility, Gene Deregulation
- Keywords
- Epigenetic, Female age, Gene regulation, Methylation pattern
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Female Patients | ICSI treatment because of male subfertility |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methylation pattern
Analysis of methylation pattern in immature oocytes (not suitable for further ICSI treatment). Methylation will be pointed out as number of methylated gene loci in comparison to the overall amount of analyzed gene loci.
Measured: 1 day (Directly after oocyte pick-up)
Gene expression
Analysis of gene expression in immature oocytes (not suitable for further ICSI treatment) will be done by quantification of selected gene transcripts (in picogram).
Measured: 1 day (Directly after oocyte pick-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start1 Jul 2018
- Primary completion17 Jul 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Infertility Treatment Center Dortmund
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wuerzburg
- Responsible party
- Sponsor
- Investigators
- Stefan Dieterle, MD, Principal investigator, Infertility Treatment Center Dortmund
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565107
- Sponsor's protocol ID
- Methylation in Germ cells
- Status last verified
- Oct 2024
- First submitted
- 5 Jun 2018
- Last updated
- 4 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Methylation Pattern in Human Germ Cells of Patients with the Desire to Have Children Undergoing Intracytoplasmic Sperm Injection Treatment
- ClinicalTrials.gov ID
- NCT03565107
- Acronym / sponsor ID
- Methylation in Germ cells
- Conditions
- Female Infertility, Gene Deregulation
- Keywords
- Epigenetic, Female age, Gene regulation, Methylation pattern
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Infertility Treatment Center DortmundUniversity, hospital or other
- Collaborators
- University of Wuerzburg
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 21 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is increasing evidence that exposure to environmental factors in early development is associated with an increased risk of metabolic and other common diseases. These increased disease risks are likely due to environmental-induced epigenetic changes leading to dysregulation of genes and signaling cascades. The best studied epigenetic modification in this context is DNA methylation. Preliminary studies have already shown that an increased father age or intracytoplasmic sperm injection affects methylation pattern in sperm or umbilical cord blood of children. Unlike sperm, less is known about the methylation of human oocytes and their susceptibility to environmental factors. The aim of this study is to analyze the methylation pattern of immature oocytes of women with decreased fertility. Based on the results of a large number of oocytes from different women, risk assessments could be made for individual factors such as the age of the patient, as well as correlations between the occurrence of changes in gene expression and the unfulfilled desire to have children. In addition, the methylation patterns in sperm from 20 patients are to be examined as reference patterns.
Detailed description
Although more than five million children have been conceived worldwide through Assisted Reproduction Techniques (ARTs), little is known about potential effects of ART in later life. So far, the focus of reproductive research is based on the success rate of infertility treatment. There is increasing evidence that exposure to environmental substances, age of the patient or in vitro culture conditions in early development is associated with a life-long increased risk of metabolic and other common diseases. These increased disease risks are likely due to environmental-induced epigenetic changes leading to dysregulation of genes and signaling cascades. These include Beckwith-Wiedemann and Angelman syndrome.
The best studied epigenetic modification in this context is DNA methylation, which regulates the gene expression in a temporally and highly coordinated manner. Preliminary studies have already shown that an increased father age influences the pattern of methylation in the sperm and umbilical cord blood of children. Moreover, intracytoplasmic sperm injection (ICSI) also leaves epigenetic signatures in umbilical cord blood. Unlike sperm, little is known about the methylation of human oocytes and their susceptibility to environmental factors. The main reason for this is the difficulty of collecting human oocytes in sufficient numbers for genome-wide analysis. The aim of this study is to analyze the methylation pattern of immature oocytes, which are not suitable for further ICSI treatment, of women with decreased fertility. The products of gene expression and also the methylation of the DNA itself can be investigated using newly developed DNA sequencing methods. Based on the results of a large number of oocytes from different women, risk assessments could be made for individual factors such as the age of the patient, as well as correlations between the occurrence of changes in gene expression and the unfulfilled desire to have children. In addition, the methylation patterns in sperms from 20 patients are to be examined as reference.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Female Patients | – | –ICSI treatment because of male subfertility |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- female patients seeking ICSI treatment because of male subfertility
Key inclusion criteria (1 listed)
- healthy females without sterility factors
Key exclusion criteria (4 listed)
- Endometriosis
- Polycystic ovary syndrome (PCO)
- Neoplasia (ovary, Uterus, breast)
- Anti-Müllerian hormone (AMH) <1 ng/ml
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Methylation pattern
Time frame: 1 day (Directly after oocyte pick-up)
Analysis of methylation pattern in immature oocytes (not suitable for further ICSI treatment). Methylation will be pointed out as number of methylated gene loci in comparison to the overall amount of analyzed gene loci.
Gene expression
Time frame: 1 day (Directly after oocyte pick-up)
Analysis of gene expression in immature oocytes (not suitable for further ICSI treatment) will be done by quantification of selected gene transcripts (in picogram).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefan Dieterle, MD principal investigator
Infertility Treatment Center Dortmund
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Female Infertility and Gene Deregulation, run by Infertility Treatment Center Dortmund at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Methylation pattern (time frame: 1 day (Directly after oocyte pick-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.