Relationship of Progesterone Levels and PregnancyNCT04707430
The Effect of Progesterone Levels on Pregnancy
An observational study of Relationship of Progesterone Levels and Pregnancy, run by Sezcan Mumusoglu at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effect of progesterone levels on pregnancy occurrence on the 3rd and 5th days after insemination. Read more about this study
- Who is it for?
- Ages Up to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Relationship of Progesterone Levels and Pregnancy
- What is being tested?
- blood progesterone test
- How many people
- 156 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2020to 1 Aug 2021
- How long will I take part?
- 12 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 Up to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Patients admitted to Hacettepe Hospital and scheduled for insemination
Who may be able to join
- Patients who have been decided for intrauterine insemination
- Patients under the age of 40
- Patients with a BMI of less than 40 kg / m2
- Cycles triggered by rhCG
- Those who have a signed and dated informed consent document that they have been informed about the study and that their consent has been obtained
Who cannot join
- Patients over the age of 40
- Patients with BMI over 40 kg / m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Progesterone Levels on the 3rd and 5th Days After Insemination on Pregnancy
The aim of this study is to investigate the effect of progesterone levels on pregnancy occurrence on the 3rd and 5th days after insemination.
Read the detailed description
Ovarian stimulation with gonadotropins is a frequently used method in patients with unexplained infertility undergoing intrauterine insemination.
Pregnancy and live birth rates after ovarian stimulation; The number of follicles in ovulatory size and responsive to ovarian stimulation is affected by many factors such as the age of the woman and the duration of infertility. Progesterone production in the luteal phase is necessary to achieve successful treatment results by increasing the receptivity of the endometrium in the secretory phase.
In assisted reproductive techniques, exogenous progesterone support in the luteal phase is a routinely used method due to higher pregnancy rates, but there is no consensus with the use of progesterone in IUI applications. In a recent meta-analysis, a positive relationship was found between gonadotropins and progesterone support when ovulation induction and intrauterine insemination were performed, while this relationship was not found with clomiphene citrate, and although letrozole and gonadotropin were used together, no significant statistics were found.
The relationship between luteal phase hormone dynamics and pregnancy outcomes in IUI is not fully understood. Although luteal phase failure is mentioned, there is no accepted definition of luteal phase failure worldwide. In one study, progesterone concentrations in the midluteal phase and pregnancy outcomes were investigated in 188 IUI cycles, predicting that low levels could predict treatment failure. In another study, a positive relationship was found between luteal phase progesterone levels and clinical pregnancy outcomes.However, the relationship between blood progesterone levels and pregnancy rates in a small number of IUI cycles has been investigated in the literature. Considering all these studies, there is no Level 1 evidence regarding the benefit of providing progesterone support in groups where the progesterone level is below a certain threshold value. In this study, we aimed to investigate the relationship between gestational outcomes by looking at progesterone values on the 3rd and 5th days after IUI in patients who were decided to be treated with IUI. By looking at these progesterone levels, we aimed to determine a threshold value for the ideal level of progesterone in the luteal phase and to be a guide in terms of possible results and methods of shaping the treatment.
- Being tested
- blood progesterone test
- Keywords
- intrauterine insemination, progesterone, pregnancy, gonadotropins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood progesterone testOther
progesterone levels on blood sample
What is being measured
The primary outcome is the main question the study is designed to answer.
The progesterone level
the effect of progesterone levels 3rd and 5th day after insemination on ongoing pregnancy
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start1 Aug 2020
- Primary completion1 May 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relationship of Progesterone Levels and PregnancyStudies 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
- 156 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Sezcan Mumusoglu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sezcan Mumusoglu, Hacettepe University
- Investigators
- Gurkan Bozdag, Prof., Study chair, Hacettepe UniversityGalip Serdar Gunalp, Prof., Study chair, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04707430
- Sponsor's protocol ID
- HU1101
- Status last verified
- Mar 2022
- First submitted
- 12 Jan 2021
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progesterone Levels on the 3rd and 5th Days After Insemination on Pregnancy
- ClinicalTrials.gov ID
- NCT04707430
- Acronym / sponsor ID
- HU1101
- Keywords
- intrauterine insemination, progesterone, pregnancy, gonadotropins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Sezcan MumusogluUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 13 Jan 2021 (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.
The aim of this study is to investigate the effect of progesterone levels on pregnancy occurrence on the 3rd and 5th days after insemination.
Detailed description
Ovarian stimulation with gonadotropins is a frequently used method in patients with unexplained infertility undergoing intrauterine insemination.
Pregnancy and live birth rates after ovarian stimulation; The number of follicles in ovulatory size and responsive to ovarian stimulation is affected by many factors such as the age of the woman and the duration of infertility. Progesterone production in the luteal phase is necessary to achieve successful treatment results by increasing the receptivity of the endometrium in the secretory phase.
In assisted reproductive techniques, exogenous progesterone support in the luteal phase is a routinely used method due to higher pregnancy rates, but there is no consensus with the use of progesterone in IUI applications. In a recent meta-analysis, a positive relationship was found between gonadotropins and progesterone support when ovulation induction and intrauterine insemination were performed, while this relationship was not found with clomiphene citrate, and although letrozole and gonadotropin were used together, no significant statistics were found.
The relationship between luteal phase hormone dynamics and pregnancy outcomes in IUI is not fully understood. Although luteal phase failure is mentioned, there is no accepted definition of luteal phase failure worldwide. In one study, progesterone concentrations in the midluteal phase and pregnancy outcomes were investigated in 188 IUI cycles, predicting that low levels could predict treatment failure. In another study, a positive relationship was found between luteal phase progesterone levels and clinical pregnancy outcomes.However, the relationship between blood progesterone levels and pregnancy rates in a small number of IUI cycles has been investigated in the literature. Considering all these studies, there is no Level 1 evidence regarding the benefit of providing progesterone support in groups where the progesterone level is below a certain threshold value. In this study, we aimed to investigate the relationship between gestational outcomes by looking at progesterone values on the 3rd and 5th days after IUI in patients who were decided to be treated with IUI. By looking at these progesterone levels, we aimed to determine a threshold value for the ideal level of progesterone in the luteal phase and to be a guide in terms of possible results and methods of shaping the treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- Up to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients admitted to Hacettepe Hospital and scheduled for insemination
Key inclusion criteria (5 listed)
- Patients who have been decided for intrauterine insemination
- Patients under the age of 40
- Patients with a BMI of less than 40 kg / m2
- Cycles triggered by rhCG
- Those who have a signed and dated informed consent document that they have been informed about the study and that their consent has been obtained
Key exclusion criteria (2 listed)
- Patients over the age of 40
- Patients with BMI over 40 kg / m2
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 |
|---|---|---|
| blood progesterone testprogesterone levels on blood sample | Other | – |
Primary outcome
The progesterone level
Time frame: up to 12 months
the effect of progesterone levels 3rd and 5th day after insemination on ongoing pregnancy
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 17 Mar 2022.
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.
Gurkan Bozdag, Prof. study chair
Hacettepe University
Galip Serdar Gunalp, Prof. study chair
Hacettepe 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 Relationship of Progesterone Levels and Pregnancy, run by Sezcan Mumusoglu 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 5 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: finished, as of the sponsor's last update on 17 Mar 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?
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?
The progesterone level (time frame: up to 12 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 17 Mar 2022.