InfertilityNCT03155048
The Effects of Estrogen on Artificial Endometrium
A study testing oral estrogen replacement therapy and Estradiol transdermal patch in people with Infertility, run by Memorial Sisli Hospital, Istanbul at 1 site in Turkey (Türkiye).
Trial summary
In this prospective randomized trial, the parameters of the frozen-thawed embryo transfer (FET) cycles were analyzed. This study was undertaken in the Department of Assisted Reproductive Technologies and Reproductive Genetics Center at Istanbul Memorial Hospital with approval of the local ethics committee. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- oral estrogen replacement therapy and Estradiol transdermal patch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2017to 1 Sep 2018
- Phase
- Interventional
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All the women with at least one day 5 or 6 blastocyst
- Appropriate endometrial thickness is more than 7 millimeters on the 14th day of artificial endometrial preparation cycle
- Age under 38 years
- Follicle stimulating hormone less than 12 IU/Liter
- No more than 2 previous treatment cycles
- No history of recurrent spontaneous abortions
Who cannot join
- Polycystic ovarian syndrome (> 30 cumulus oocyte complexes retrieved at the pick-up)
- Endocrine or metabolic disorder
- Endometriosis
- Embryos derived from donated gametes
- Any underlying diseases (kidney, liver or heart diseases)
- Bad-quality embryos
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- Uterine malformation
- Endometrial polyp
- Severe male factor (Azoospermia)
- Body mass index more than 30
- Thrombophilia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Memorial Sisli Hospital ART and Genetics Center
Istanbul
About this study
Official title: The Effects of Transdermal Estradiol and Oral Estradiol Valerate on Clinical Outcomes of Frozen-thawed Embryo Transfer Cycles: A Randomized Clinical Trial
In this prospective randomized trial, the parameters of the frozen-thawed embryo transfer (FET) cycles were analyzed. This study was undertaken in the Department of Assisted Reproductive Technologies and Reproductive Genetics Center at Istanbul Memorial Hospital with approval of the local ethics committee. The aim of this prospective randomized clinical trial was to compare two methods of endometrial preparation for FET, oral estradiol and estradiol transdermal patch.
Read the detailed description
In this prospective randomized trial, the parameters of the frozen-thawed embryo transfer (FET) cycles were analyzed. This study was undertaken in the Department of Assisted Reproductive Technologies and Reproductive Genetics Center at Istanbul Memorial Hospital with approval of the local ethics committee. The aim of this prospective randomized clinical trial was to compare two methods of endometrial preparation for FET, oral estradiol and estradiol transdermal patch.
A total number of 317 patients who underwent frozen -thawed embryo transfer cycles were enrolled in this study and randomized to two groups including 160 patients with the usage of 6 milligrams/day oral estradiol and 154 patients with the usage of 3.9 milligrams estradiol transdermal patch. Randomization was done with http://www.randomization.com. The patients were given sufficient information to provide written informed consent. All the women underwent intracytoplasmic sperm injection (ICSI).
Treatment protocols: All the patients selected for the research were primed for a frozen transfer using two different ways of exogenous steroid therapy.
In the study group with transdermal route (n=154), 3.9 milligrams of estradiol transdermal patch was applied every other day from the second day of menstruation cycle, and each patch was removed after day. In the control group with oral route (n=160), at the time of cycle, 6 milligrams of oral estradiol valerate was started daily. In both groups, clinical monitoring was done by transvaginal ultrasound from the 11th day of the cycle to measure endometrial thickness. If endometrial thickness was more than 7 millimeter, 90 milligrams vaginal natural progesterone was added. Embryo transfer was done after 5 days.
The primary outcome measure was endometrial thickness on the day of progesterone administration. The secondary outcome measures were chemical and clinical pregnancy, implantation rates, abortion rates, live birth rates, and cycle cancellation rate.
- Conditions
- Infertility
- Being tested
- oral estrogen replacement therapy, Estradiol transdermal patch
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral estrogen replacement therapyDrug
oral estradiol group for endometrial preparation
Estradiol transdermal patchDrug
transdermal estradiol group for endometrial preparation
| Study group | Role | What they receive |
|---|---|---|
| oral estradiol group | Active comparator | patients with the usage of 6 milligrams/day oral estradiol Receives: Drug: oral estrogen replacement therapy |
| estradiol transdermal patch group | Active comparator | patients with the usage of 3.9 milligrams estradiol transdermal patch Receives: Drug: Estradiol transdermal patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endometrial thickness on the day of progesterone administration
In frozen thawed embryo transfer cycles, endometrial preparation with estrogen was performed. Estrogen was applied from the second day of menstruation cycle to 11th day of cycle. Endometrial thickness was measured by transvaginal ultrasound. If endometrial thickness was more than 7 millimeters, endometrial thickness was ready for embryo transfer on the day of progesterone administration.
Measured: 6 months
Secondary outcomes (1)
Implantation rate
The effects of transdermal estradiol and oral estradiol valerate on implantation rates were evaluated. Implantation rates are described as gestational sacs seen by transvaginal ultrasound per embryo transfer.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study start1 May 2017
- Primary completion1 Oct 2017
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sisli Hospital, Istanbul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Semra Kahraman, Memorial Sisli Hospital, Istanbul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155048
- Sponsor's protocol ID
- EndometrialpreparingSK002
- Status last verified
- Nov 2018
- First submitted
- 10 May 2017
- Last updated
- 6 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Transdermal Estradiol and Oral Estradiol Valerate on Clinical Outcomes of Frozen-thawed Embryo Transfer Cycles: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03155048
- Acronym / sponsor ID
- EndometrialpreparingSK002
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Memorial Sisli Hospital, IstanbulUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 16 May 2017 (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.
In this prospective randomized trial, the parameters of the frozen-thawed embryo transfer (FET) cycles were analyzed. This study was undertaken in the Department of Assisted Reproductive Technologies and Reproductive Genetics Center at Istanbul Memorial Hospital with approval of the local ethics committee. The aim of this prospective randomized clinical trial was to compare two methods of endometrial preparation for FET, oral estradiol and estradiol transdermal patch.
Detailed description
In this prospective randomized trial, the parameters of the frozen-thawed embryo transfer (FET) cycles were analyzed. This study was undertaken in the Department of Assisted Reproductive Technologies and Reproductive Genetics Center at Istanbul Memorial Hospital with approval of the local ethics committee. The aim of this prospective randomized clinical trial was to compare two methods of endometrial preparation for FET, oral estradiol and estradiol transdermal patch.
A total number of 317 patients who underwent frozen -thawed embryo transfer cycles were enrolled in this study and randomized to two groups including 160 patients with the usage of 6 milligrams/day oral estradiol and 154 patients with the usage of 3.9 milligrams estradiol transdermal patch. Randomization was done with http://www.randomization.com. The patients were given sufficient information to provide written informed consent. All the women underwent intracytoplasmic sperm injection (ICSI).
Treatment protocols: All the patients selected for the research were primed for a frozen transfer using two different ways of exogenous steroid therapy.
In the study group with transdermal route (n=154), 3.9 milligrams of estradiol transdermal patch was applied every other day from the second day of menstruation cycle, and each patch was removed after day. In the control group with oral route (n=160), at the time of cycle, 6 milligrams of oral estradiol valerate was started daily. In both groups, clinical monitoring was done by transvaginal ultrasound from the 11th day of the cycle to measure endometrial thickness. If endometrial thickness was more than 7 millimeter, 90 milligrams vaginal natural progesterone was added. Embryo transfer was done after 5 days.
The primary outcome measure was endometrial thickness on the day of progesterone administration. The secondary outcome measures were chemical and clinical pregnancy, implantation rates, abortion rates, live birth rates, and cycle cancellation rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oral estradiol group | Active comparator | Drug: oral estrogen replacement therapypatients with the usage of 6 milligrams/day oral estradiol |
| estradiol transdermal patch group | Active comparator | Drug: Estradiol transdermal patchpatients with the usage of 3.9 milligrams estradiol transdermal patch |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- All the women with at least one day 5 or 6 blastocyst
- Appropriate endometrial thickness is more than 7 millimeters on the 14th day of artificial endometrial preparation cycle
- Age under 38 years
- Follicle stimulating hormone less than 12 IU/Liter
- No more than 2 previous treatment cycles
Key exclusion criteria (11 listed)
- Polycystic ovarian syndrome (> 30 cumulus oocyte complexes retrieved at the pick-up)
- Endocrine or metabolic disorder
- Endometriosis
- Embryos derived from donated gametes
- Any underlying diseases (kidney, liver or heart diseases)
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 |
|---|---|---|
| oral estrogen replacement therapyoral estradiol group for endometrial preparation | Drug | oral estradiol group |
| Estradiol transdermal patchtransdermal estradiol group for endometrial preparation | Drug | estradiol transdermal patch group |
Primary outcome
Endometrial thickness on the day of progesterone administration
Time frame: 6 months
In frozen thawed embryo transfer cycles, endometrial preparation with estrogen was performed. Estrogen was applied from the second day of menstruation cycle to 11th day of cycle. Endometrial thickness was measured by transvaginal ultrasound. If endometrial thickness was more than 7 millimeters, endometrial thickness was ready for embryo transfer on the day of progesterone administration.
1 secondary outcome
Implantation rate
Time frame: 12 months
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 6 Nov 2018.
- 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.
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?
A study testing oral estrogen replacement therapy and Estradiol transdermal patch in people with Infertility, run by Memorial Sisli Hospital, Istanbul 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 6 inclusion and 11 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 6 Nov 2018. 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?
Endometrial thickness on the day of progesterone administration (time frame: 6 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 6 Nov 2018.