Subfertility, FemaleNCT05211583
Serial Progesterone Level Measurements During the Menstrual Cycle in Subfertile Women
An observational study of Subfertility, Female and Ovulation Disorder, run by Turgut Aydın at 1 site in Turkey (Türkiye).
Trial summary
Ovulatory dysfunction is identified in 15% of all infertile couples and it accounts for 40% of female infertility. Ovulatory dysfunction may be more subtle in women with regular menses. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Subfertility, Female, Ovulation Disorder
- What is being tested?
- Serum progesterone levels
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Dec 2021to Apr 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population will be selected from women who attended to Acıbadem University Atakent Hospital Infertility Clinic for evaluation of infertility.
Who may be able to join
- women that have regular menses (menstrual cycle length 21-35 days)
- women who will come visits regularly
- women that are trying to conceive more than 1 year if women age is less than 35 years or more than 6 months if women age is >35 years
Who cannot join
- women who do not menstruate regularly
- women that use hormonal contraception
- women who take drugs that will interfere with steroid hormone metabolism
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Acibadem University
Istanbul, 34357
Turgut Aydin, +905323722713, turgut.aydin@acibadem.com
About this study
Official title: Evaluation of Serum Hormone Levels Referenced to Ovulation in Subfertile Women With Regular Menses
Ovulatory dysfunction is identified in 15% of all infertile couples and it accounts for 40% of female infertility. Ovulatory dysfunction may be more subtle in women with regular menses. Detecting the day of ovulation is necessary for optimizing natural conception, diagnosis of cycle disturbances and also timing for embryo transfer in natural cycle frozen-thawed embryo transfers. In order to diagnose ovulatory dysfunction, ovulation physiology and change of reproductive hormones during the menstrual cycle should be understood. In the present study we aimed to evaluate serial serum hormonal cut-off levels referenced to ovulation in subfertile women with regular menses.
- Conditions
- Subfertility, Female, Ovulation Disorder
- Being tested
- Serum progesterone levels
- Keywords
- ovulation, progesterone, ovulatory dysfunction, subfertility
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum progesterone levelsDiagnostic test
In order to show change of serum progesterone levels, serial venous blood sampling will be done and also transvaginal ultrasonography will be performed to show ovulation.
| Study group | Role | What they receive |
|---|---|---|
| subfertile women | Subfertile women with regular menses (menstrual cycle length range from 21 to 35 days) will be examined by transvaginal ultrasonography at menstruation, before the anticipated date of ovulation and after ovulation. Serum hormone levels will be measured at menstruation, before ovulation and after ovulation with a serial manner. Receives: Diagnostic Test: Serum progesterone levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of serum progesterone levels referenced to ovulation
Serum progesterone levels will be measured when dominant follicule is 17 mm in diameter and then serial measurements of hormones will be done and ovulation will be detected both hormonally and ultrasonographically. The range of serum progesterone will be reported referenced to ovulation.
Measured: Progesterone levels will be measured serially when dominant follicule reaches 17 mm in diameter and after that 1-2 days interval until to ovulation; 1 week after ultrasound and hormone-detected ovulation
Change of reproductive hormone levels referenced to ovulation
Serum estradiol and luteinising hormone (LH) levels will be measured when dominant folicule is 17 mm in diameter and then serial measurements of hormones will be done and ovulation will be detected both hormonally and ultrasonographically. The ranges for serum hormones will be reported.
Measured: Estradiol and LH levels will be measured serially when dominant follicule reaches 17 mm in diameter and after that 1-2 days interval until to ovulation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start10 Dec 2021
- Primary completionMar 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subfertility, FemaleStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turgut Aydın
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Turgut Aydın, Acibadem University
- Investigators
- Turgut Aydın, Principal investigator, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211583
- Sponsor's protocol ID
- Progesterone
- Status last verified
- Jan 2022
- First submitted
- 14 Jan 2022
- Last updated
- 27 Jan 2022
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Serum Hormone Levels Referenced to Ovulation in Subfertile Women With Regular Menses
- ClinicalTrials.gov ID
- NCT05211583
- Acronym / sponsor ID
- Progesterone
- Conditions
- Subfertility, Female, Ovulation Disorder
- Keywords
- ovulation, progesterone, ovulatory dysfunction, subfertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Turgut AydınUniversity, hospital or other
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 27 Jan 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.
Ovulatory dysfunction is identified in 15% of all infertile couples and it accounts for 40% of female infertility. Ovulatory dysfunction may be more subtle in women with regular menses. Detecting the day of ovulation is necessary for optimizing natural conception, diagnosis of cycle disturbances and also timing for embryo transfer in natural cycle frozen-thawed embryo transfers. In order to diagnose ovulatory dysfunction, ovulation physiology and change of reproductive hormones during the menstrual cycle should be understood. In the present study we aimed to evaluate serial serum hormonal cut-off levels referenced to ovulation in subfertile women with regular menses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subfertile women | – | Diagnostic Test: Serum progesterone levelsSubfertile women with regular menses (menstrual cycle length range from 21 to 35 days) will be examined by transvaginal ultrasonography at menstruation, before the anticipated date of ovulation and after ovulation. Serum hormone levels will be measured at menstruation, before ovulation and after ovulation with a serial manner. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population will be selected from women who attended to Acıbadem University Atakent Hospital Infertility Clinic for evaluation of infertility.
Key inclusion criteria (3 listed)
- women that have regular menses (menstrual cycle length 21-35 days)
- women who will come visits regularly
- women that are trying to conceive more than 1 year if women age is less than 35 years or more than 6 months if women age is >35 years
Key exclusion criteria (3 listed)
- women who do not menstruate regularly
- women that use hormonal contraception
- women who take drugs that will interfere with steroid hormone metabolism
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 |
|---|---|---|
| Serum progesterone levelsIn order to show change of serum progesterone levels, serial venous blood sampling will be done and also transvaginal ultrasonography will be performed to show ovulation. | Diagnostic test | subfertile women |
Primary outcome
Change of serum progesterone levels referenced to ovulation
Time frame: Progesterone levels will be measured serially when dominant follicule reaches 17 mm in diameter and after that 1-2 days interval until to ovulation; 1 week after ultrasound and hormone-detected ovulation
Serum progesterone levels will be measured when dominant follicule is 17 mm in diameter and then serial measurements of hormones will be done and ovulation will be detected both hormonally and ultrasonographically. The range of serum progesterone will be reported referenced to ovulation.
Change of reproductive hormone levels referenced to ovulation
Time frame: Estradiol and LH levels will be measured serially when dominant follicule reaches 17 mm in diameter and after that 1-2 days interval until to ovulation.
Serum estradiol and luteinising hormone (LH) levels will be measured when dominant folicule is 17 mm in diameter and then serial measurements of hormones will be done and ovulation will be detected both hormonally and ultrasonographically. The ranges for serum hormones will be reported.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- 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.
Turgut Aydın principal investigator
Acibadem University
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 Subfertility, Female and Ovulation Disorder, run by Turgut Aydın 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 3 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 27 Jan 2022. 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 Aydın (+905323722713, turgut.aydin@acibadem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of serum progesterone levels referenced to ovulation (time frame: Progesterone levels will be measured serially when dominant follicule reaches 17 mm in diameter and after that 1-2 days interval until to ovulation; 1 week after ultrasound and hormone-detected ovulation). 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 27 Jan 2022.