Embryo TransferNCT03518528
Comparison of Vaginal and Transdermal Oestrogen Before Frozen Thawed Embryo Transfer
An observational study of Embryo Transfer and Infertility, run by University Hospital, Angers at 1 site in France.
Trial summary
The purpose of this study is to compare pregnancy outcomes of frozen-thawed embryo transfer after endometrial preparation with vaginal estradiol or transdermal estradiol and to evaluate women's satisfaction Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Embryo Transfer, Infertility
- What is being tested?
- Estradiol 2 MG and Estradiol 100 µg
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 30 Aug 2018to Dec 2018
- How long will I take part?
- 1 Year
- 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 43 years
- Women only
- No healthy volunteers
- Adult
Study population: patients follow in our assisted reprodution unit, requesting frozen-thawed embryo transfer after ivf or icsi
Who may be able to join
- age ≥ 18 and <43
- frozen-thawed embryo transfer after exogenously administered estrogen in either way transdermal or vaginal
- patients who accepted being included and signed the consent forms.
Who cannot join
- patient who refuse to participate
- frozen-thawed embryotransfer after stimulated or natural cycle
- oocyte or sperm donation
- endometrial thickness after 21 days <6mm
- non-french speaking patients
- women under legal guardianship
- women with no health or social security coverage
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Angers
Angers, 49100
CORROENNE ROMAIN, 0650678034 ext. 33, corroenne.ROMAIN@gmail.com
BOUET PIERRE EMMANUEL, 0241353647, PierreEmmanuel.BOUET@chu-angers.fr
About this study
Official title: Endometrial Estrogen Preparation Before Frozen-thawed Embryo Transfer : Comparison of Vaginal and Transdermal Administration
The purpose of this study is to compare pregnancy outcomes of frozen-thawed embryo transfer after endometrial preparation with vaginal estradiol or transdermal estradiol and to evaluate women's satisfaction
Read the detailed description
Frozen-thawed transfer embryo are more and more frequent but to date, there is no consensus on the ideal management of the adequate endometrial preparation.
Artificial preparation of endometrium is commonly used in assisted reproduction center because it is more easy to schedule.
Estradiol could be administrate by oral, vaginal or transdermal, but no protocol seems to improve clinical pregnancy rates.
To investigator's knowledge, transdermal estradiol has never been compare to vaginal administration before frozen-thawed embryo transfer.
Because transdermal administration could improve satisfaction of patients and reduce duration of treatment (when compare to oral administration), the investigators conduct a prospective study to compare clinical pregnancy rate after transdermal or vaginal estradiol administration to prepare the endometrium before frozen-thawed embryo transfer.
The investigator also evaluate side effects and patients satisfaction in both protocol.
The patients choose if they prefer vaginal or transdermal protocol after receiving sufficient information during medical consultation.
- Conditions
- Embryo Transfer, Infertility
- Being tested
- Estradiol 2 MG, Estradiol 100 µg
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol 2 MGDrug
Also called provames 2mg
Vaginal estradiol (Provames, Sanofi) 4mg per day from day 3 to first pregnancy test. If pregnancy test is positive, treatment is to continue until 8 weeks
Estradiol 100 µgDrug
Also called vivelledot 100 µg
transdermal estradiol (Vivelledot, Novartis) 100 µg on day 3, then 200 µg day 7 and every 4 days, until first pregnancy test. If pregnancy test is positive, treatment is to continue until 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| transdermal | transdermal estradiol (Vivelledot, Novartis) 100 µg on day 3, then 200 µg day 7 and every 4 days, until first pregnancy test. If pregnancy test is positive, treatment is to continue until 8 weeks. Receives: Drug: Estradiol 100 µg | |
| vaginal | Vaginal estradiol (Provames, Sanofi) 4mg per day from day 3 to first pregnancy test. If pregnancy test is positive, treatment is to continue until 8 weeks Receives: Drug: Estradiol 2 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy
defined as fetal cardiac activity at 12 weeks of gestation
Measured: 12 weeks
Secondary outcomes (9)
chemical pregnancy
Defined as serum HCG levels >10 IU/L, 14 days after the embryo transfer, followed by a rapid decrease until being undetectable
Measured: 6 weeks
spontaneous pregnancy loss
Including early and late pregnancy losses
Measured: 12 weeks
plasmatic estradiol concentration on the day of transfer
plasmatic estradiol concentration on the day of transfer
Measured: 21 days
plasmatic lh concentration on the day of transfer
plasmatic lh concentration on the day of transfer
Measured: 21 days
plasmatic progesterone concentration on the day of transfer
plasmatic progesterone concentration on the day of transfer
Measured: 21 days
endometrial thickness
sonographic measurement of endometrial thickness on the day of transfer
Measured: 21 days
annulation
defined when transfer is cancel if endometrial thickness is too thick (>6-7mm), when spontaneous ovulation is found with progesterone plasmatic increase and corpus luteum is seen by sonography or when unpredictable events occur (infections, ZIKA suspicion, endometriosis crisis, bad observance…). Annulation could be decided by biologist in case of embryo's lysis or bad quality seen after thawing.
Measured: 21 days
treatment duration
duration of treatment before transfer
Measured: 21 days
satisfaction evaluated by anonymous survey the day of transfer
evaluated by anonymous survey the day of transfer
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start30 Aug 2018
- Primary completionSep 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embryo TransferStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- 100 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- BOUET Pierre Emmanuel, Study director, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518528
- Sponsor's protocol ID
- PATCHS2018
- Status last verified
- May 2018
- First submitted
- 24 Mar 2018
- Last updated
- 31 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometrial Estrogen Preparation Before Frozen-thawed Embryo Transfer : Comparison of Vaginal and Transdermal Administration
- ClinicalTrials.gov ID
- NCT03518528
- Acronym / sponsor ID
- PATCHS2018
- Conditions
- Embryo Transfer, Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 30 Aug 2018 (actual)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 8 May 2018 (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 study is to compare pregnancy outcomes of frozen-thawed embryo transfer after endometrial preparation with vaginal estradiol or transdermal estradiol and to evaluate women's satisfaction
Detailed description
Frozen-thawed transfer embryo are more and more frequent but to date, there is no consensus on the ideal management of the adequate endometrial preparation.
Artificial preparation of endometrium is commonly used in assisted reproduction center because it is more easy to schedule.
Estradiol could be administrate by oral, vaginal or transdermal, but no protocol seems to improve clinical pregnancy rates.
To investigator's knowledge, transdermal estradiol has never been compare to vaginal administration before frozen-thawed embryo transfer.
Because transdermal administration could improve satisfaction of patients and reduce duration of treatment (when compare to oral administration), the investigators conduct a prospective study to compare clinical pregnancy rate after transdermal or vaginal estradiol administration to prepare the endometrium before frozen-thawed embryo transfer.
The investigator also evaluate side effects and patients satisfaction in both protocol.
The patients choose if they prefer vaginal or transdermal protocol after receiving sufficient information during medical consultation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transdermal | – | Drug: Estradiol 100 µgtransdermal estradiol (Vivelledot, Novartis) 100 µg on day 3, then 200 µg day 7 and every 4 days, until first pregnancy test. If pregnancy test is positive, treatment is to continue until 8 weeks. |
| vaginal | – | Drug: Estradiol 2 MGVaginal estradiol (Provames, Sanofi) 4mg per day from day 3 to first pregnancy test. If pregnancy test is positive, treatment is to continue until 8 weeks |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- patients follow in our assisted reprodution unit, requesting frozen-thawed embryo transfer after ivf or icsi
Key inclusion criteria (3 listed)
- age ≥ 18 and <43
- frozen-thawed embryo transfer after exogenously administered estrogen in either way transdermal or vaginal
- patients who accepted being included and signed the consent forms.
Key exclusion criteria (7 listed)
- patient who refuse to participate
- frozen-thawed embryotransfer after stimulated or natural cycle
- oocyte or sperm donation
- endometrial thickness after 21 days <6mm
- non-french speaking patients
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 |
|---|---|---|
| Estradiol 2 MGAlso: provames 2mgVaginal estradiol (Provames, Sanofi) 4mg per day from day 3 to first pregnancy test. If pregnancy test is positive, treatment is to continue until 8 weeks | Drug | vaginal |
| Estradiol 100 µgAlso: vivelledot 100 µgtransdermal estradiol (Vivelledot, Novartis) 100 µg on day 3, then 200 µg day 7 and every 4 days, until first pregnancy test. If pregnancy test is positive, treatment is to continue until 8 weeks. | Drug | transdermal |
Primary outcome
clinical pregnancy
Time frame: 12 weeks
defined as fetal cardiac activity at 12 weeks of gestation
9 secondary outcomes
chemical pregnancy
Time frame: 6 weeks
spontaneous pregnancy loss
Time frame: 12 weeks
plasmatic estradiol concentration on the day of transfer
Time frame: 21 days
plasmatic lh concentration on the day of transfer
Time frame: 21 days
plasmatic progesterone concentration on the day of transfer
Time frame: 21 days
endometrial thickness
Time frame: 21 days
annulation
Time frame: 21 days
treatment duration
Time frame: 21 days
satisfaction evaluated by anonymous survey the day of transfer
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Embryo Transfer
Not yet recruiting
Cryopreserved Pre-embryo Transfer in a Cytokine-rich Medium Versus Hyaluronic Acid
Frozen Embryo Transfer (FET)
Active, not recruitingPhase 3
Human Menopausal Gonadotropin Research in Infertility Assessing Cumulative Live Birth With Frozen Embryo Transfer.
Infertility (IVF Patients)
Not yet recruitingObservational study
Linzagolix in Adenomyosis and Recurrent Implantation Failure
Adenomyosis of Uterus, Implantation Failure
RecruitingPhase 2
Effect of FB301 on Vaginal Bacterial Profile in Women With Asymptomatic Vaginal Dysbiosis Undergoing a Mock Frozen Embryo Transfer Cycle
Vaginal Dysbiosis
RecruitingPhase 2/3
Thymosin-α1 for Recurrent Implantation Failure
Recurrent Implantation Faliure
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.
BOUET Pierre Emmanuel study director
University Hospital, Angers
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 Embryo Transfer and Infertility, run by University Hospital, Angers at 1 site in France.
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 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: status not confirmed, as of the sponsor's last update on 31 Aug 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 France. 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 BOUET Pierre-Emmanuel, MD (+33241353637, pierreemmanuel.bouet@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical pregnancy (time frame: 12 weeks). 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 31 Aug 2018.