InfertilityNCT02378584
Natural Cycle Versus Endometrial Preparation for Healthy Blastocyst Transfer
A study testing embryo transfer in people with Infertility, run by European Hospital at 2 sites in Italy.
Trial summary
This study evaluates the difference in pregnancy rate transferring a healthy blastocyst in natural or artificial cycle. Read more about this study
- Who is it for?
- Ages 20 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- embryo transfer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 2 sitesItaly
- Study dates
- Feb 2015to Sep 2015
- 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 20 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- frozen-thawed healthy blastocyst
Who cannot join
- post thawed not survival healthy blastocyst
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
European Hospital
Rome, RM, 00149
European Hospital
Rome, Roma, 00149
About this study
Official title: The Clinical Results After Frozen-thawed Healthy Blastocyst Transfer in Natural Cycle Versus Cycle With Endometrial Preparation
This study evaluates the difference in pregnancy rate transferring a healthy blastocyst in natural or artificial cycle.
Read the detailed description
The aim of the study was to verify the implantation capacity and ongoing pregnancy rate of vitrified warmed euploid blastocyst in natural cycle versus endometrial artificial cycle with gonadotropin-releasing hormone (GnRH-agonist) pituitary suppression.
- Conditions
- Infertility
- Being tested
- embryo transfer
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
embryo transferOther
Also called drug adminstration, clinical controls
healthy blastocyst transfer in natural and hormonal cycle
| Study group | Role | What they receive |
|---|---|---|
| natural cycle | Other | Ultrasound controls and endocrine blood test to asses the day of ovulation for embryo transfer Receives: Other: embryo transfer |
| hormonal cycle | Active comparator | Ultrasound controls and endocrine blood test to asses the endometrium thickness for embryo transfer Receives: Other: embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical pregnancy rate confirmed by ultrasound evidence of fetal heart activity
Measured: 12 weeks after embryo transfer
Secondary outcomes (3)
live-birth rate confirmed by the number of born
Measured: term pregnancy delivery
cost-benefit of two endometrial preparation protocol
Assessment of drug cost and the count of clinical visit, laboratory dosages and venous sampling
Measured: 30 weeks beginning from day 21 of the previous cycle day up to the pregnancy test
The number of patients with the anxiety and depression increase
the psychological questionnaire (HADS) administered on four time point
Measured: Six weeks beginning on the day of treatment start, on the day of progesterone administration, on the day of blastocyst transfer and the pregnancy test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2015
- Study completionSep 2015
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.
- 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
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ERmanno Greco, MD, Study director, European Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378584
- Sponsor's protocol ID
- CC1978MA
- Status last verified
- Jul 2015
- First submitted
- 6 Feb 2015
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Greco E, Litwicka K, Arrivi C, Varricchio MT, Caragia A, Greco A, Minasi MG, Fiorentino F. The endometrial preparation for frozen-thawed euploid blastocyst transfer: a prospective randomized trial comparing clinical results from natural modified cycle and exogenous hormone stimulation with GnRH agonist. J Assist Reprod Genet. 2016 Jul;33(7):873-84. doi: 10.1007/s10815-016-0736-y. Epub 2016 May 24.
PubMed 27221477
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Results After Frozen-thawed Healthy Blastocyst Transfer in Natural Cycle Versus Cycle With Endometrial Preparation
- ClinicalTrials.gov ID
- NCT02378584
- Acronym / sponsor ID
- CC1978MA
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- European HospitalUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 Mar 2015 (estimated)
- 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 evaluates the difference in pregnancy rate transferring a healthy blastocyst in natural or artificial cycle.
Detailed description
The aim of the study was to verify the implantation capacity and ongoing pregnancy rate of vitrified warmed euploid blastocyst in natural cycle versus endometrial artificial cycle with gonadotropin-releasing hormone (GnRH-agonist) pituitary suppression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| natural cycle | Other | Other: embryo transferUltrasound controls and endocrine blood test to asses the day of ovulation for embryo transfer |
| hormonal cycle | Active comparator | Other: embryo transferUltrasound controls and endocrine blood test to asses the endometrium thickness for embryo transfer |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- frozen-thawed healthy blastocyst
Key exclusion criteria (1 listed)
- post thawed not survival healthy blastocyst
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 |
|---|---|---|
| embryo transferAlso: drug adminstration, clinical controlshealthy blastocyst transfer in natural and hormonal cycle | Other | hormonal cycle, natural cycle |
Primary outcome
clinical pregnancy rate confirmed by ultrasound evidence of fetal heart activity
Time frame: 12 weeks after embryo transfer
3 secondary outcomes
live-birth rate confirmed by the number of born
Time frame: term pregnancy delivery
cost-benefit of two endometrial preparation protocol
Time frame: 30 weeks beginning from day 21 of the previous cycle day up to the pregnancy test
The number of patients with the anxiety and depression increase
Time frame: Six weeks beginning on the day of treatment start, on the day of progesterone administration, on the day of blastocyst transfer and the pregnancy test
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 28 Jan 2016.
- Derived from this study: PubMed 27221477Greco E, Litwicka K, Arrivi C, Varricchio MT, Caragia A, Greco A, Minasi MG, Fiorentino F. The endometrial preparation for frozen-thawed euploid blastocyst transfer: a prospective randomized trial comparing clinical results from natural modified cycle and exogenous hormone stimulation with GnRH agonist. J Assist Reprod Genet. 2016 Jul;33(7):873-84. doi: 10.1007/s10815-016-0736-y. Epub 2016 May 24.
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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.
ERmanno Greco, MD study director
European Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing embryo transfer in people with Infertility, run by European Hospital at 2 sites in Italy.
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 1 inclusion and 1 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 28 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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?
clinical pregnancy rate confirmed by ultrasound evidence of fetal heart activity (time frame: 12 weeks after embryo transfer). 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 NCT02378584, 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 28 Jan 2016.