InfertilityNCT04733235
the Effect of Endometrial Compaction Caused by Progesterone Effect on Pregnancy Outcomes
An observational study of Infertility and Female Infertility, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this prospective cohort study is to assess the effect of endometrial compaction caused by progesterone effect on pregnancy outcomes Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female Infertility, Frozen-thawed Embryo Transfer
- What is being tested?
- Progesterone
- How many people
- 205 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2020to 15 Jul 2021
- 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
- Healthy volunteers accepted
- Adult
Study population: Women underwent frozen embryo transfer
Who may be able to join
- Woman aged 18-40 years
- Presence of high quality (>2BB) blastocyst
- Hormonal(estrogen and progesterone) frozen- thawed embryo transfer cycles
- presence of high quality blastocyst cryopreserved by vitrification method.
- A single embryo transfer
Who cannot join
- Presence of uterine pathology
- Participants whose optimal endometrial image cannot be obtained due to uterine position
- Participants whose treatments were canceled for any reason before embryo transfer
- Participants which had embryo transfer on the day 2 or 3 (at the cleavage stage)
- Participants who had 2 embryo transfer
- Presence of low quality (<2BB) blastocyst
- > 15% loss of viability in the embryo during embryo thawing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Progesterone Induced Endometrial Compaction on Pregnancy Outcomes in Frozen-thawed Embryo Transfer at the Blastocyst Stage
The purpose of this prospective cohort study is to assess the effect of endometrial compaction caused by progesterone effect on pregnancy outcomes
Read the detailed description
For a pregnancy to occur, the embryo must implant in a receptive endometrium during the window of implantation, which is thought to occur from day 22 to 24 of an idealized 28-day cycle. Early studies have suggested that assessing endometrial thickness with the use of ultrasound may be an alternative to invasive techniques such as endometrial biopsy for attempting to determine a receptive endometrium for frozen-thawed embryo transfer (FET).
A preovulatory endometrial thickness of 7 mm or more is considered to be the cutoff for endometrial receptivity, below which many physicians would cancel an embryo transfer. However, in most studies in the literature, endometrial thickness was measured either on the day of hCG in fresh embryo transfer cases or on the last day of estrogen treatment in thawed embryo transfers. There are a limited number of studies evaluating the luteal period, embryo transfer day and endometrial thickness.
Accordingly, in this prospective cohort study is to assess the effect of endometrial compaction caused by progesterone effect on pregnancy outcomes
- Being tested
- Progesterone
- Keywords
- infertility, female infertility, frozen- thawed embryo transfer, female
- Medical subject headings
- Infertility, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProgesteroneDrug
Also called Diagnostic Test: Blood test Measurement of E2, P4, LH, FSH hormones Diagnostic Test: Transvaginal
ultrasound measurements of endometrial thickness at the end of the estrogen phase and the day of embryo transfer.
| Study group | Role | What they receive |
|---|---|---|
| with endometrial compaction | Participants who have endometrial compaction caused by progesterone effects on undergoing frozen embryo transfer with artificial hormone replacement Receives: Drug: Progesterone | |
| without endometrial compaction | Participants who have not endometrial compaction caused by progesterone effects on undergoing frozen embryo transfer with artificial hormone replacement Receives: Drug: Progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in endometrial thickness
changing in millimeters of endometrial thickness at the end of the estrogen phase and the day of embryo transfer.
Measured: 1 year
ongoing pregnancy rates.
pregnancy beyond 12 weeks of gestational age.
Measured: 1 year
Secondary outcomes (4)
The Correlation of Serum Progesterone Levels With the Degree of Endometrial Compaction on the Day of Frozen Embryo Transfer
comparison of progesterone levels and endometrial thickness
Measured: On the day of frozen embryo transfer
Clinical pregnancy rate
6th week gestational age
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
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 posted2 Feb 2021
- Study start1 Jul 2020
- Primary completion15 Apr 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Akdeniz 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
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ŞAFAK OLGAN, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733235
- Sponsor's protocol ID
- AkdenizUKD
- Status last verified
- Dec 2022
- First submitted
- 17 Jan 2021
- Last updated
- 3 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Haas J, Smith R, Zilberberg E, Nayot D, Meriano J, Barzilay E, Casper RF. Endometrial compaction (decreased thickness) in response to progesterone results in optimal pregnancy outcome in frozen-thawed embryo transfers. Fertil Steril. 2019 Sep;112(3):503-509.e1. doi: 10.1016/j.fertnstert.2019.05.001. Epub 2019 Jun 24.
PubMed 31248618
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progesterone Induced Endometrial Compaction on Pregnancy Outcomes in Frozen-thawed Embryo Transfer at the Blastocyst Stage
- ClinicalTrials.gov ID
- NCT04733235
- Acronym / sponsor ID
- AkdenizUKD
- Keywords
- infertility, female infertility, frozen- thawed embryo transfer, female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 2 Feb 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 purpose of this prospective cohort study is to assess the effect of endometrial compaction caused by progesterone effect on pregnancy outcomes
Detailed description
For a pregnancy to occur, the embryo must implant in a receptive endometrium during the window of implantation, which is thought to occur from day 22 to 24 of an idealized 28-day cycle. Early studies have suggested that assessing endometrial thickness with the use of ultrasound may be an alternative to invasive techniques such as endometrial biopsy for attempting to determine a receptive endometrium for frozen-thawed embryo transfer (FET).
A preovulatory endometrial thickness of 7 mm or more is considered to be the cutoff for endometrial receptivity, below which many physicians would cancel an embryo transfer. However, in most studies in the literature, endometrial thickness was measured either on the day of hCG in fresh embryo transfer cases or on the last day of estrogen treatment in thawed embryo transfers. There are a limited number of studies evaluating the luteal period, embryo transfer day and endometrial thickness.
Accordingly, in this prospective cohort study is to assess the effect of endometrial compaction caused by progesterone effect on pregnancy outcomes
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with endometrial compaction | – | Drug: ProgesteroneParticipants who have endometrial compaction caused by progesterone effects on undergoing frozen embryo transfer with artificial hormone replacement |
| without endometrial compaction | – | Drug: ProgesteroneParticipants who have not endometrial compaction caused by progesterone effects on undergoing frozen embryo transfer with artificial hormone replacement |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women underwent frozen embryo transfer
Key inclusion criteria (5 listed)
- Woman aged 18-40 years
- Presence of high quality (>2BB) blastocyst
- Hormonal(estrogen and progesterone) frozen- thawed embryo transfer cycles
- presence of high quality blastocyst cryopreserved by vitrification method.
- A single embryo transfer
Key exclusion criteria (7 listed)
- Presence of uterine pathology
- Participants whose optimal endometrial image cannot be obtained due to uterine position
- Participants whose treatments were canceled for any reason before embryo transfer
- Participants which had embryo transfer on the day 2 or 3 (at the cleavage stage)
- Participants who had 2 embryo transfer
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 |
|---|---|---|
| ProgesteroneAlso: Diagnostic Test: Blood test Measurement of E2, P4, LH, FSH hormones Diagnostic Test: Transvaginalultrasound measurements of endometrial thickness at the end of the estrogen phase and the day of embryo transfer. | Drug | with endometrial compaction, without endometrial compaction |
Primary outcome
The change in endometrial thickness
Time frame: 1 year
changing in millimeters of endometrial thickness at the end of the estrogen phase and the day of embryo transfer.
ongoing pregnancy rates.
Time frame: 1 year
pregnancy beyond 12 weeks of gestational age.
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
Time frame: after 5th gestational week
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 3 Jan 2023.
- Results publication: PubMed 31248618Haas J, Smith R, Zilberberg E, Nayot D, Meriano J, Barzilay E, Casper RF. Endometrial compaction (decreased thickness) in response to progesterone results in optimal pregnancy outcome in frozen-thawed embryo transfers. Fertil Steril. 2019 Sep;112(3):503-509.e1. doi: 10.1016/j.fertnstert.2019.05.001. Epub 2019 Jun 24.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Female Infertility, run by Akdeniz 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 5 inclusion and 7 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 3 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?
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 change in endometrial thickness (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT04733235, which also lists 1 linked publication.
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 3 Jan 2023; AzTrials last refreshed its copy on 6 Nov 2026.