Duration of Estrogen AdministrationNCT05825885
The Impact of Estrogen Administration Duration in Hormonally Prepared Frozen Embryo Transfer Cycles
An observational study of Duration of Estrogen Administration, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
This prospective controlled study aimed to investigate the effect of the duration of estrogen (E2) administration prior to progesterone (P) initiation on live birth rates (LBR) in frozen embryo transfer (FET) cycles. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Duration of Estrogen Administration
- What is being tested?
- E2
- How many people
- 420 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 1 May 2023
- 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: All patients who have artificial endometrial preparation with high-quality blastocysts between January 2020 and December 2021 were included.
Who may be able to join
- Exogenous hormone preparation of the endometrial lining
- High embryo quality ((≥2BB) according to Alpha criteria
- Embryo transfer at the blastocyst stage
Who cannot join
- - Patients whose treatments were canceled for any reason before the embryo transfer procedure
- Patients who underwent embryo transfer in the cleavage stage
- Presence of low-quality (<2BB) blastocysts
- >15% loss of viability of the embryo during embryo thawing,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Estrogen Administration Duration on Live Birth Rates in Hormonally Prepared Frozen Embryo Transfer Cycles: a Prospective Controlled Study
This prospective controlled study aimed to investigate the effect of the duration of estrogen (E2) administration prior to progesterone (P) initiation on live birth rates (LBR) in frozen embryo transfer (FET) cycles.
The study was conducted at a single tertiary-care in vitro fertilization (IVF) center and included 486 patients undergoing high-quality frozen blastocyst transfer in a hormone replacement therapy (HRT) cycle. Patients scheduled for E2 therapy were administered either 5-7, 8-10, or 11-13 days of treatment, depending on their presentation day. After the E2-only phase, if the endometrial thickness was above 7mm, P was initiated (daily 300mg of vaginal micronized P tablets), and FET was performed on the 6th day of P treatment. The primary outcome measure was LBR.
Read the detailed description
The timing of P initiation in HRT cycles depends on the thickness and morphology of the endometrium, which are influenced by the duration of E2 treatment. Although numerous studies have examined the effect of E2 treatment duration on endometrial thickness and morphology, the results have been inconsistent, and the impact on live birth rates (LBR) remains unclear. Previous research has explored the impact of standard 12-day E2 therapy and prolonged periods of E2 administration on pregnancy outcomes. However, the present study aims to compare the effects of standard 12-day E2 therapy with shorter-term E2 application and evaluate their impact on treatment outcomes.
To test hypothesis, investigators conducted a prospective analysis of about 500 hormonally prepared frozen embryo transfer (FET) cycles performed between January 2020 and December 2021 at IVF center in Akdeniz University. The objective of this study was to determine the optimal duration of estrogen (E2) therapy prior to progesterone (P) initiation for FET cycles in terms of live birth rate (LBR).
In IVF center, patients with frozen embryos routinely applied to the center on weekdays (Monday, Wednesday, and Friday) as part of a predetermined treatment plan. Patients who presented to the clinic during their menstrual periods were scheduled to receive E2 therapy for a duration of either 5-7, 8-10, or 11-13 days, depending on the day they presented. After the application of micronized E2 at a daily dose of 4-6mg, transvaginal ultrasonography was performed to assess endometrial thickness. If the endometrial thickness was found to be above 7mm, daily 300mg of vaginal micronized P tablets were initiated, and FET was performed on the 6th day of P treatment. Patients whose endometrial thickness was less than 7 millimeters on transvaginal ultrasonography after the application of E2 treatment for the specified day and who had to continue estrogen therapy were not included in the study.
The duration of E2 administration prior to P initiation was categorized into three groups: 5-7 days, 8-10 days, and 11-13 days. The primary outcome of this study was LBR, which was defined as the delivery of a live-born infant after 24 weeks of gestation. Secondary outcomes included implantation rate, clinical pregnancy rate, and miscarriage rate.
- Conditions
- Duration of Estrogen Administration
- Being tested
- E2
- Keywords
- Endometrial compaction, Endometrial receptivity, Endometrial thickness, Frozen embryo transfer, HRT, Pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E2Drug
micronized E2 at a daily dose of 4-6mg,
| Study group | Role | What they receive |
|---|---|---|
| 5-7 days E2 therapy | Patient group treated with e2 for 5-7 days | |
| 8-10 days E2 therapy | Patient group treated with e2 for 5-7 days | |
| 11-13 days E2 therapy | Patient group treated with e2 for 5-7 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth rate
the birth ratio of a baby who showed any sign of life
Measured: 2 years
Secondary outcomes (3)
implantation rate
the percentage of embryos which successfully undergo implantation compared to the number of embryos transferred in a given period.
Measured: 2 years
clinical pregnancy rate
the number of clinical pregnancy divided by the number of embryo transfer cycle for each group
Measured: 2 years
miscarriage rate
rate of the spontaneous loss of a pregnancy before the 20th week
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start1 Jan 2020
- Primary completion31 Dec 2021
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Duration of Estrogen AdministrationStudies 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
- 420 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
- NCT05825885
- Sponsor's protocol ID
- 498496942
- Status last verified
- Feb 2025
- First submitted
- 11 Apr 2023
- Last updated
- 27 Feb 2025
- 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 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Estrogen Administration Duration on Live Birth Rates in Hormonally Prepared Frozen Embryo Transfer Cycles: a Prospective Controlled Study
- ClinicalTrials.gov ID
- NCT05825885
- Acronym / sponsor ID
- 498496942
- Conditions
- Duration of Estrogen Administration
- Keywords
- Endometrial compaction, Endometrial receptivity, Endometrial thickness, Frozen embryo transfer, HRT, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 420 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 24 Apr 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.
This prospective controlled study aimed to investigate the effect of the duration of estrogen (E2) administration prior to progesterone (P) initiation on live birth rates (LBR) in frozen embryo transfer (FET) cycles.
The study was conducted at a single tertiary-care in vitro fertilization (IVF) center and included 486 patients undergoing high-quality frozen blastocyst transfer in a hormone replacement therapy (HRT) cycle. Patients scheduled for E2 therapy were administered either 5-7, 8-10, or 11-13 days of treatment, depending on their presentation day. After the E2-only phase, if the endometrial thickness was above 7mm, P was initiated (daily 300mg of vaginal micronized P tablets), and FET was performed on the 6th day of P treatment. The primary outcome measure was LBR.
Detailed description
The timing of P initiation in HRT cycles depends on the thickness and morphology of the endometrium, which are influenced by the duration of E2 treatment. Although numerous studies have examined the effect of E2 treatment duration on endometrial thickness and morphology, the results have been inconsistent, and the impact on live birth rates (LBR) remains unclear. Previous research has explored the impact of standard 12-day E2 therapy and prolonged periods of E2 administration on pregnancy outcomes. However, the present study aims to compare the effects of standard 12-day E2 therapy with shorter-term E2 application and evaluate their impact on treatment outcomes.
To test hypothesis, investigators conducted a prospective analysis of about 500 hormonally prepared frozen embryo transfer (FET) cycles performed between January 2020 and December 2021 at IVF center in Akdeniz University. The objective of this study was to determine the optimal duration of estrogen (E2) therapy prior to progesterone (P) initiation for FET cycles in terms of live birth rate (LBR).
In IVF center, patients with frozen embryos routinely applied to the center on weekdays (Monday, Wednesday, and Friday) as part of a predetermined treatment plan. Patients who presented to the clinic during their menstrual periods were scheduled to receive E2 therapy for a duration of either 5-7, 8-10, or 11-13 days, depending on the day they presented. After the application of micronized E2 at a daily dose of 4-6mg, transvaginal ultrasonography was performed to assess endometrial thickness. If the endometrial thickness was found to be above 7mm, daily 300mg of vaginal micronized P tablets were initiated, and FET was performed on the 6th day of P treatment. Patients whose endometrial thickness was less than 7 millimeters on transvaginal ultrasonography after the application of E2 treatment for the specified day and who had to continue estrogen therapy were not included in the study.
The duration of E2 administration prior to P initiation was categorized into three groups: 5-7 days, 8-10 days, and 11-13 days. The primary outcome of this study was LBR, which was defined as the delivery of a live-born infant after 24 weeks of gestation. Secondary outcomes included implantation rate, clinical pregnancy rate, and miscarriage rate.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 5-7 days E2 therapy | – | –Patient group treated with e2 for 5-7 days |
| 8-10 days E2 therapy | – | –Patient group treated with e2 for 5-7 days |
| 11-13 days E2 therapy | – | –Patient group treated with e2 for 5-7 days |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- All patients who have artificial endometrial preparation with high-quality blastocysts between January 2020 and December 2021 were included.
Key inclusion criteria (3 listed)
- Exogenous hormone preparation of the endometrial lining
- High embryo quality ((≥2BB) according to Alpha criteria
- Embryo transfer at the blastocyst stage
Key exclusion criteria (4 listed)
- - Patients whose treatments were canceled for any reason before the embryo transfer procedure
- Patients who underwent embryo transfer in the cleavage stage
- Presence of low-quality (<2BB) blastocysts
- >15% loss of viability of the embryo during embryo thawing,
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 |
|---|---|---|
| E2micronized E2 at a daily dose of 4-6mg, | Drug | – |
Primary outcome
live birth rate
Time frame: 2 years
the birth ratio of a baby who showed any sign of life
3 secondary outcomes
implantation rate
Time frame: 2 years
clinical pregnancy rate
Time frame: 2 years
miscarriage rate
Time frame: 2 years
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 27 Feb 2025.
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 Duration of Estrogen Administration, 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 3 inclusion and 4 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 27 Feb 2025. 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?
live birth rate (time frame: 2 years). 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 Feb 2025.