Preimplantation Genetic ScreeningNCT05220995
The Effects of Miminal Stimulation Protocol on Preimplantation Genetic Screening
An observational study of Preimplantation Genetic Screening, run by Gokalp Oner at 2 sites in Turkey (Türkiye).
Trial summary
PGS has been the most effective method for embryo selection in IVF cycles. Euploidy rates decrease significantly with advancing maternal age (AMA). The dosage of gonadotropins also may be increased to recruit an adequate number of follicles in AMA women, minimal Stimulation Protocol (MSP) with the new combination of… Read more about this study
- Who is it for?
- Ages 38 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preimplantation Genetic Screening
- What is being tested?
- protocol
- How many people
- 200 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 May 2021to 25 Jan 2022
- 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 38 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: 200 advanced maternal aged women
Who may be able to join
- Exclusion Criteria: Severe male factor, endometriosis, and absolute tubal factor were excluded in this study.
- -
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Not yet recruiting
Gokalp Oner
Kayseri, Gevher Nesibe, 38039
Gokalp Oner, 905339268238, onerg@yahoo.com
- Recruiting
Gokalp Oner
Kayseri, Gevher Nesibe, 38039
Gokalp Oner, 0905062346822, onerg@yahoo.com
About this study
Official title: The Effects of Miminal Stimulation Protocol on Clinical Outcomes of Advanced Maternal Aged Women With Preimplantation Genetic Screening
PGS has been the most effective method for embryo selection in IVF cycles. Euploidy rates decrease significantly with advancing maternal age (AMA). The dosage of gonadotropins also may be increased to recruit an adequate number of follicles in AMA women, minimal Stimulation Protocol (MSP) with the new combination of human menopausal gonadotrophin (hMG) and clomiphene citrate (CC) for controlled ovarian hyperstimulation is defined for poor ovarian response women. The aim of this study is to show minimal stimulation protocol affect euploidy and pregnancy rates in preimplatation genetic screening (PGS) cycles with single embryo transfer.
- Conditions
- Preimplantation Genetic Screening
- Being tested
- protocol
- Keywords
- preimplantation genetic screening, gonadotropin dosage, euploidy rates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protocolGenetic
ovarian stimulation protocols on euploid rates were compared.
| Study group | Role | What they receive |
|---|---|---|
| 100 patients with minimal | In advancing maternal age (AMA) women, minimal stimulation protocol (MSP) with the new combination of human menopausal gonadotrophin (hMG) and clomiphene citrate (CC) were performed for controlled ovarian hyperstimulation is defined for poor ovarian response women. Receives: Genetic: protocol | |
| 100 patients with recombinant FSH antagonist protocol | In advancing maternal age (AMA) women, flexible antagonist protocol with recombinant FSH were performed for controlled ovarian hyperstimulation is defined for poor ovarian response women. Receives: Genetic: protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
euploid rates
the effects of different stimulation protocols on euploid rates
Measured: 3 months
Secondary outcomes (1)
pregnancy rates
the effects of different stimulation protocols on pregnancy rates
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start15 May 2021
- Primary completion23 Jan 2022 (estimated)
- Study completion25 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preimplantation Genetic ScreeningStudies 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gokalp Oner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gokalp Oner, Nigde Omer Halisdemir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220995
- Sponsor's protocol ID
- 31.01.2022
- Status last verified
- Jan 2022
- First submitted
- 31 Jan 2022
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We can not share.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Miminal Stimulation Protocol on Clinical Outcomes of Advanced Maternal Aged Women With Preimplantation Genetic Screening
- ClinicalTrials.gov ID
- NCT05220995
- Acronym / sponsor ID
- 31.01.2022
- Conditions
- Preimplantation Genetic Screening
- Keywords
- preimplantation genetic screening, gonadotropin dosage, euploidy rates
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Gokalp OnerUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 23 Jan 2022 (estimated)
- Study completion
- 25 Jan 2022 (estimated)
- First posted
- 2 Feb 2022 (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.
PGS has been the most effective method for embryo selection in IVF cycles. Euploidy rates decrease significantly with advancing maternal age (AMA). The dosage of gonadotropins also may be increased to recruit an adequate number of follicles in AMA women, minimal Stimulation Protocol (MSP) with the new combination of human menopausal gonadotrophin (hMG) and clomiphene citrate (CC) for controlled ovarian hyperstimulation is defined for poor ovarian response women. The aim of this study is to show minimal stimulation protocol affect euploidy and pregnancy rates in preimplatation genetic screening (PGS) cycles with single embryo transfer.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100 patients with minimal | – | Genetic: protocolIn advancing maternal age (AMA) women, minimal stimulation protocol (MSP) with the new combination of human menopausal gonadotrophin (hMG) and clomiphene citrate (CC) were performed for controlled ovarian hyperstimulation is defined for poor ovarian response women. |
| 100 patients with recombinant FSH antagonist protocol | – | Genetic: protocolIn advancing maternal age (AMA) women, flexible antagonist protocol with recombinant FSH were performed for controlled ovarian hyperstimulation is defined for poor ovarian response women. |
Who may qualify
- Ages
- 38 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 200 advanced maternal aged women
Key inclusion criteria (2 listed)
- Exclusion Criteria: Severe male factor, endometriosis, and absolute tubal factor were excluded in this study.
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| protocolovarian stimulation protocols on euploid rates were compared. | Genetic | 100 patients with minimal, 100 patients with recombinant FSH antagonist protocol |
Primary outcome
euploid rates
Time frame: 3 months
the effects of different stimulation protocols on euploid rates
1 secondary outcome
pregnancy rates
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
- Individual participant dataSharing planned: No. We can not share.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preimplantation Genetic Screening, run by Gokalp Oner at 2 sites in Turkey (Türkiye).
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 2 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
euploid rates (time frame: 3 months). 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 2 Feb 2022.