Infertility, FemaleNCT04554654
Progesterone Levels and Endometrial Compaction in Frozen-Thawed Embryo Transfer Cycles
An observational study of Infertility, Female and Infertility of Uterine Origin, run by Cem Demirel at 1 site in Turkey (Türkiye).
Trial summary
This study is intended to determine whether there is a correlation between endometrial compaction and serum progesterone levels on the day of frozen embryo transfers by using transvaginal sonography for the endometrial assessment. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female, Infertility of Uterine Origin, Implantation; Placenta
- What is being tested?
- transvaginal ultrasound,
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2020to 15 Feb 2021
- How long will I take part?
- 5 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
- Healthy volunteers accepted
- Adult
Study population: Women underwent frozen embryo transfer
Who may be able to join
- Woman aged 20-40 years
- Hormonal(estrogen and progesterone) frozen- thawed embryo transfer cycles
- Having available blastocyst(s) cryopreserved by vitrification method.
Who cannot join
- Recurrent implantation failure
- Recurrent pregnancy loss
- Presence of uterine pathology
- Requirement for fresh embryo(s);
- Presence of any clinically relevant systemic disease contraindicated for assisted reproduction or pregnancy
- Allergy history for relevant drugs
Show all 10Show fewer
- Body mass index of <18 or >38 kg/m2 at screening
- Current breastfeeding or pregnancy
- Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic visits and laboratory tests
- Natural or modified natural cycles
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ataşehir Memorial Hospital IVF Department
Istanbul, 34758
Fırat Tulek, MD, +905306084874, firattulek@yahoo.com
About this study
Official title: The Correlation of Serum Progesterone Levels With the Degree of Endometrial Compaction on the Day of Frozen Embryo Transfer
This study is intended to determine whether there is a correlation between endometrial compaction and serum progesterone levels on the day of frozen embryo transfers by using transvaginal sonography for the endometrial assessment.
Read the detailed description
This study is planned to be conducted by prospectively evaluating approximately 200 frozen embryo transfers within 6 months in a single center. Patients planned to be included in the study are started estrodiol 6 mg / day on day2-3 of mensturation. 12 days after the start of estrogen, patients who have endometrial thickness over 7 mm are then started vaginal progesterone supplementation as per routine practice and are eventually proceeded to embryo transfer either on day 4 or 6 of progesterone supplementation. In this study investigators are intended to measure endometrial thickness transvaginally on the day of embryo transfer to accurately determine the presence of endometrial compaction, assess serum progesterone levels, evaluate any possible correlations between endometrial compaction, serum progesterone levels and pregnancy rates.
- Being tested
- transvaginal ultrasound,
- Keywords
- frozen-thawed embryo transfer, endometrial compaction, progesterone
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transvaginal ultrasound,Diagnostic test
Also called serum progesterone level measurement
transvaginal ultrasound performed on day of the start of progesterone supplementation and on the day of frozen embryo transfer; serum progesterone level measurement on day of frozen embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| frozen embryo transfer cycles | patients undergoing frozen embryo transfer with artificial hormone replacement Receives: Diagnostic Test: transvaginal ultrasound, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rates
Presence of at least one live fetus at the end of the 12th gestational week in patients with endometrial compaction compared to patients without endometrial compaction after frozen embryo transfer
Measured: 12 weeks after the last menstrual period of the patient
Secondary outcomes (4)
The Correlation of Serum Progesterone Levels With the Degree of Endometrial Compaction on the Day of Frozen Embryo Transfer
endometrium compacted (became thinner) after the administration of progesterone
Measured: On the day of frozen embryo transfer
Clinical pregnancy rate
Presence of an intrauterine gestational sac with fetal heart beat at 7th week of gestation
Measured: 6-7 weeks after the last menstrual period of the patient
Implantation rate
Percentage of gestational sacs compared to the number of embryos transferred
Measured: 5 weeks after the last menstrual period of the patient
Clinical miscarriage rate
pregnancy loss after ultrasonographic detection of an intrauterine gestational sac
Measured: after 5th gestational week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start15 Jun 2020
- Primary completion15 Jan 2021 (estimated)
- Study completion15 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, 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
- 200 participants (estimated)
- Target duration
- 5 Months
Sponsor and investigators
- Lead sponsor
- Cem Demirel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cem Demirel, Memorial Ataşehir Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554654
- Sponsor's protocol ID
- 9995381
- Status last verified
- Jan 2021
- First submitted
- 4 Sep 2020
- Last updated
- 11 Jan 2021
- 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 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation of Serum Progesterone Levels With the Degree of Endometrial Compaction on the Day of Frozen Embryo Transfer
- ClinicalTrials.gov ID
- NCT04554654
- Acronym / sponsor ID
- 9995381
- Keywords
- frozen-thawed embryo transfer, endometrial compaction, progesterone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cem DemirelUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 15 Jan 2021 (estimated)
- Study completion
- 15 Feb 2021 (estimated)
- First posted
- 18 Sep 2020 (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.
This study is intended to determine whether there is a correlation between endometrial compaction and serum progesterone levels on the day of frozen embryo transfers by using transvaginal sonography for the endometrial assessment.
Detailed description
This study is planned to be conducted by prospectively evaluating approximately 200 frozen embryo transfers within 6 months in a single center. Patients planned to be included in the study are started estrodiol 6 mg / day on day2-3 of mensturation. 12 days after the start of estrogen, patients who have endometrial thickness over 7 mm are then started vaginal progesterone supplementation as per routine practice and are eventually proceeded to embryo transfer either on day 4 or 6 of progesterone supplementation. In this study investigators are intended to measure endometrial thickness transvaginally on the day of embryo transfer to accurately determine the presence of endometrial compaction, assess serum progesterone levels, evaluate any possible correlations between endometrial compaction, serum progesterone levels and pregnancy rates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| frozen embryo transfer cycles | – | Diagnostic Test: transvaginal ultrasound,patients undergoing frozen embryo transfer with artificial hormone replacement |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women underwent frozen embryo transfer
Key inclusion criteria (3 listed)
- Woman aged 20-40 years
- Hormonal(estrogen and progesterone) frozen- thawed embryo transfer cycles
- Having available blastocyst(s) cryopreserved by vitrification method.
Key exclusion criteria (10 listed)
- Recurrent implantation failure
- Recurrent pregnancy loss
- Presence of uterine pathology
- Requirement for fresh embryo(s);
- Presence of any clinically relevant systemic disease contraindicated for assisted reproduction or pregnancy
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 |
|---|---|---|
| transvaginal ultrasound,Also: serum progesterone level measurementtransvaginal ultrasound performed on day of the start of progesterone supplementation and on the day of frozen embryo transfer; serum progesterone level measurement on day of frozen embryo transfer | Diagnostic test | frozen embryo transfer cycles |
Primary outcome
Ongoing pregnancy rates
Time frame: 12 weeks after the last menstrual period of the patient
Presence of at least one live fetus at the end of the 12th gestational week in patients with endometrial compaction compared to patients without endometrial compaction after frozen embryo transfer
4 secondary outcomes
The Correlation of Serum Progesterone Levels With the Degree of Endometrial Compaction on the Day of Frozen Embryo Transfer
Time frame: On the day of frozen embryo transfer
Clinical pregnancy rate
Time frame: 6-7 weeks after the last menstrual period of the patient
Implantation rate
Time frame: 5 weeks after the last menstrual period of the patient
Clinical miscarriage rate
Time frame: after 5th gestational week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
- 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.
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, Female and Infertility of Uterine Origin, run by Cem Demirel 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 10 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 11 Jan 2021. 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 Cem Demirel, MD (+905333229039, cemdemirel@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rates (time frame: 12 weeks after the last menstrual period of the patient). 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 11 Jan 2021.