InfertilityNCT05690360
Pregnancy Outcomes of Patients Having NC-FET Regarding the Progesterone Levels
An observational study of Infertility, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial summary
We recently identify in our previous study 'NCT052115832' the progesterone levels for the embryo transfer in natural thaw cycles. Since it is shown that progesterone levels work better than LH levels in order to detect the time to transfer, we aimed to show the pregnancy outcomes of the natural thaw cycles which had… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Infertility
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2022to 15 Aug 2023
- How long will I take part?
- 3 Months
- 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 20 to 40 years
- Women only
- Adult
Study population: Participants are going to be selected from the patients who applied to infertility clinic, and are pregnant with in vitro fertilization natural cycle- frozen embryo transfer.
Who may be able to join
- patients with regular menstrual cycle
- patients aged btw 20-40
- patients with pregnancy with NC-FET by using the progesterone for the detection of ovulation
Who cannot join
- Spontenous pregnancies
- Multiple pregnancies
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acibadem University Atakent Hospital
Istanbul, 34303
NAZLI ALBAYRAK, MD, 00905054111626, albayraknazli@gmail.com
TURGUT AYDIN, MD, 00905323722713, turgut.aydin@acibadem.com
About this study
Official title: Evaluation of the Pregnancy Outcomes and Time to Embryo Transfer Regarding the Progesterone Levels of Natural Cycle-FETs
We recently identify in our previous study 'NCT052115832' the progesterone levels for the embryo transfer in natural thaw cycles. Since it is shown that progesterone levels work better than LH levels in order to detect the time to transfer, we aimed to show the pregnancy outcomes of the natural thaw cycles which had the transfer date regarding the progesterone levels.
- Conditions
- Infertility
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Cummulative Live Birth Rate
Live birth rates of Patient with NC-FET followed up with progesterone levels
Measured: 10 months
Biochemical pregnancy results
Biochemical pregnancy results of patients with NC-FET followed up with progesterone levels
Measured: 2 months
Pregnancy complications
Obstetric Complications of Patient with NC-FET followed up with progesterone levels
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start15 Nov 2022
- Primary completion15 Apr 2023 (estimated)
- Study completion15 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazli Albayrak, Acibadem University
- Investigators
- NAZLI ALBAYRAK, MD, Principal investigator, Acıbadem University School of MedicineTURGUT AYDIN, MD, Principal investigator, Acıbadem University School of MedicineNADIYE KOROGLU, MD, Principal investigator, Acıbadem University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690360
- Sponsor's protocol ID
- 2022-17/60
- Status last verified
- Jan 2023
- First submitted
- 10 Jan 2023
- Last updated
- 19 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Pregnancy Outcomes and Time to Embryo Transfer Regarding the Progesterone Levels of Natural Cycle-FETs
- ClinicalTrials.gov ID
- NCT05690360
- Acronym / sponsor ID
- 2022-17/60
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 15 Apr 2023 (estimated)
- Study completion
- 15 Aug 2023 (estimated)
- First posted
- 19 Jan 2023 (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.
We recently identify in our previous study 'NCT052115832' the progesterone levels for the embryo transfer in natural thaw cycles. Since it is shown that progesterone levels work better than LH levels in order to detect the time to transfer, we aimed to show the pregnancy outcomes of the natural thaw cycles which had the transfer date regarding the progesterone levels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Participants are going to be selected from the patients who applied to infertility clinic, and are pregnant with in vitro fertilization natural cycle- frozen embryo transfer.
Key inclusion criteria (3 listed)
- patients with regular menstrual cycle
- patients aged btw 20-40
- patients with pregnancy with NC-FET by using the progesterone for the detection of ovulation
Key exclusion criteria (2 listed)
- Spontenous pregnancies
- Multiple pregnancies
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
Cummulative Live Birth Rate
Time frame: 10 months
Live birth rates of Patient with NC-FET followed up with progesterone levels
Biochemical pregnancy results
Time frame: 2 months
Biochemical pregnancy results of patients with NC-FET followed up with progesterone levels
Pregnancy complications
Time frame: 10 months
Obstetric Complications of Patient with NC-FET followed up with progesterone levels
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2023.
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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.
NAZLI ALBAYRAK, MD principal investigator
Acıbadem University School of Medicine
TURGUT AYDIN, MD principal investigator
Acıbadem University School of Medicine
NADIYE KOROGLU, MD principal investigator
Acıbadem University School of Medicine
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 Infertility, run by Acibadem University at 1 site 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 3 inclusion and 2 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 19 Jan 2023. 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 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?
Contact Turgut Aydin, MD (00905323722713, turgut.aydin@acibadem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cummulative Live Birth Rate (time frame: 10 months). The study lists 3 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 19 Jan 2023.