InfertilityNCT03395665
Estradiol, Progesterone and Endometrial Thickness in Frozen Euploid Embryo Transfer
An observational study of Infertility and Preimplantation Genetic Diagnosis/Screening, run by Fundacion Dexeus at 1 site in Spain.
Trial summary
The development and improvement in Preimplantation genetic diagnosis/screening (PGS) in association with the efficacy and security of vitrification and trophectoderm biopsy, more efficient stimulation schemes and laboratory improvements in culture and embryo selection have contributed to high success of the assisted… Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Infertility, Preimplantation Genetic Diagnosis/Screening, Miscarriage
- What is being tested?
- Estradiol level, Progesterone level and Endometrial thickness
- How many people
- 299 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2014to Jan 2018
- 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
- Adult
Study population: Women who underwent blastocyst trophectoderm biopsy and PGS and frozen-thawed embryo transfers(PGS-FET) performed after the In Vitro Fertilization (IVF) . PGS was implemented as 46-chromosome screening, using array comparative genomic hybridization (aCGH) from Day 5 trophectoderm biopsy. Whole-genome amplification, processing and analyses were performed using the kits, software and protocols for array Comparative Genomic Hybridisation (aCGH) analysis provided by the manufacturer (SurePlex® DNA Amplification System, 24Sure® Microarray Pack, Bluefuse®, Illlumina®).
Who may be able to join
- Frozen embryo transfer (FET) of at least one single euploid embryo.
- Estradiol > 75pg/ml.
- Progesterone > 4 ng/ml.
- Endometrial thickness between 6 mm and 18 mm.
Who cannot join
- Patients with FET of no diagnostic or mosaic embryos, or known uterine abnormality were excluded.
- Natura cycle protocol.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Obstetrics, Gynaecology and Reproduction Instituto Universitario Dexeus
Barcelona, 08028
About this study
The development and improvement in Preimplantation genetic diagnosis/screening (PGS) in association with the efficacy and security of vitrification and trophectoderm biopsy, more efficient stimulation schemes and laboratory improvements in culture and embryo selection have contributed to high success of the assisted reproductive technologies(ART). Transferring an euploid embryo avoids one of the main reasons of miscarriage and implantation failure ( Rubio et al, 22016) and overcomes one of the most important confounding factors. Usually, the transfer of euploid embryos is performed under standard hormone replacement therapy (HRT) and are referred to as FET-PGS cycles( Frozen embryo transfer). The study of FET-PGS cycles with the transfer of a single euploid blastocyst is the best model for evaluation of the impact of the endometrial preparation . Among factors influencing FET outcomes, patient's age, endometrial preparation, endometrium thickness, endometrial pattern, number and quality of embryos transferred , difficulty at ET, recently P4 have received more attention .
The importance of Progesterone (P4) in embryo implantation has been widely studied. P4 plays an important role in endometrial gland formation, embryonic implantation and pregnancy maintenance, both in natural and artificial cycles.
- Being tested
- Estradiol level, Progesterone level, Endometrial thickness
- Medical subject headings
- Infertility, Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Estradiol levelOther
Estradiol level measured at previous day of embryo transfer procedure
Progesterone levelOther
Progesterone level measured at previous day of embryo transfer procedure
Endometrial thicknessOther
Endometrial thickness measured at previous day of embryo transfer procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate
Measured: Ten months after transfer procedure
Miscarriage rate
Miscarriage was defined as a loss following a positive pregnancy test and/or detectable Gestational sac
Measured: Any pregnancy loss before week 20
Pregnancy rate
Measured: 6 weeks after transfer procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2018
- Study startJan 2014
- Primary completionDec 2017
- Study completionJan 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Dexeus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buenaventura Coroleu, Fundacion Dexeus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03395665
- Sponsor's protocol ID
- SMD-2018-01
- Status last verified
- Feb 2018
- First submitted
- 4 Jan 2018
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estradiol, Progesterone and Endometrial Thickness in Frozen Euploid Embryo Transfer
- ClinicalTrials.gov ID
- NCT03395665
- Acronym / sponsor ID
- SMD-2018-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Fundacion DexeusUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 10 Jan 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 development and improvement in Preimplantation genetic diagnosis/screening (PGS) in association with the efficacy and security of vitrification and trophectoderm biopsy, more efficient stimulation schemes and laboratory improvements in culture and embryo selection have contributed to high success of the assisted reproductive technologies(ART). Transferring an euploid embryo avoids one of the main reasons of miscarriage and implantation failure ( Rubio et al, 22016) and overcomes one of the most important confounding factors. Usually, the transfer of euploid embryos is performed under standard hormone replacement therapy (HRT) and are referred to as FET-PGS cycles( Frozen embryo transfer). The study of FET-PGS cycles with the transfer of a single euploid blastocyst is the best model for evaluation of the impact of the endometrial preparation . Among factors influencing FET outcomes, patient's age, endometrial preparation, endometrium thickness, endometrial pattern, number and quality of embryos transferred , difficulty at ET, recently P4 have received more attention .
The importance of Progesterone (P4) in embryo implantation has been widely studied. P4 plays an important role in endometrial gland formation, embryonic implantation and pregnancy maintenance, both in natural and artificial cycles.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women who underwent blastocyst trophectoderm biopsy and PGS and frozen-thawed embryo transfers(PGS-FET) performed after the In Vitro Fertilization (IVF) . PGS was implemented as 46-chromosome screening, using array comparative genomic hybridization (aCGH) from Day 5 trophectoderm biopsy. Whole-genome amplification, processing and analyses were performed using the kits, software and protocols for array Comparative Genomic Hybridisation (aCGH) analysis provided by the manufacturer (SurePlex® DNA Amplification System, 24Sure® Microarray Pack, Bluefuse®, Illlumina®).
Key inclusion criteria (4 listed)
- Frozen embryo transfer (FET) of at least one single euploid embryo.
- Estradiol > 75pg/ml.
- Progesterone > 4 ng/ml.
- Endometrial thickness between 6 mm and 18 mm.
Key exclusion criteria (2 listed)
- Patients with FET of no diagnostic or mosaic embryos, or known uterine abnormality were excluded.
- Natura cycle protocol.
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 levelEstradiol level measured at previous day of embryo transfer procedure | Other | – |
| Progesterone levelProgesterone level measured at previous day of embryo transfer procedure | Other | – |
| Endometrial thicknessEndometrial thickness measured at previous day of embryo transfer procedure | Other | – |
Primary outcome
Live birth rate
Time frame: Ten months after transfer procedure
Miscarriage rate
Time frame: Any pregnancy loss before week 20
Miscarriage was defined as a loss following a positive pregnancy test and/or detectable Gestational sac
Pregnancy rate
Time frame: 6 weeks after transfer procedure
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 Feb 2018.
- Related InfoLink provided by the sponsor.
- 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?
An observational study of Infertility and Preimplantation Genetic Diagnosis/Screening, run by Fundacion Dexeus at 1 site in Spain.
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 4 inclusion and 2 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 Feb 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 Spain. 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: Ten months after transfer procedure). The study lists 3 primary outcomes in all. 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 28 Feb 2018.