Oocyte DonationNCT03088735
Transfer Strategy in an Oocyte Donation Programme
A study testing Blastocyst-stage embryo transfer strategy and Cleavage-stage embryo transfer strategy in people with Oocyte Donation and Infertility, Female, run by Fundacion Dexeus at 1 site in Spain.
Trial summary
It has been previously shown that although the activation of the embryonic genome can begin as early as two days of initiation of the embryonic development (D2), it is expressed on day 3 (D3). Without this activation, the embryo can not continue its development. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Oocyte Donation, Infertility, Female, Embryo Transfer
- What is being tested?
- Blastocyst-stage embryo transfer strategy and Cleavage-stage embryo transfer strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteSpain
- Study dates
- 5 Apr 2017to 31 Aug 2019
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients under their first or second cycle of a synchronous (fresh) oocyte donation cycle.
Who cannot join
- Preimplantation genetic screening or diagnosis cycles.
- Patients with strict blastocyst-stage embryo transfer indication by the couple's treating physician.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department Obstetric, Gynecologic and Reproductive Medicine
Barcelona, Barcelons, 08028
About this study
Official title: Pilot Study of the Best Transfer Strategy in an Oocyte Donation Programme: an Intention to Treat Randomized Controlled Trial
It has been previously shown that although the activation of the embryonic genome can begin as early as two days of initiation of the embryonic development (D2), it is expressed on day 3 (D3). Without this activation, the embryo can not continue its development. Therefore, it has been suggested that extended culture to blastocyst stage could be an option to identify and better select embryos that have been able to carry out this activation. The purpose of this study is to compare cumulative pregnancy and live birth rates following transfer of cleavage embryos or blastocysts.
- Conditions
- Oocyte Donation, Infertility, Female, Embryo Transfer
- Being tested
- Blastocyst-stage embryo transfer strategy, Cleavage-stage embryo transfer strategy
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blastocyst-stage embryo transfer strategyProcedure or surgery
Intra-uterine transfer of blastocist if in cleavage embryo stage the oocyte recipient has a mínimum of 3 availables embryos with at least one of good quality to transfer and also the inta-uterine transfer of cleavage embryo (day 3) when the recipient doesn't have the previous criteria.
Cleavage-stage embryo transfer strategyProcedure or surgery
Inta-uterine transferring of cleavage embryo transfer (day 3 of develpment) in oocyte recipients
| Study group | Role | What they receive |
|---|---|---|
| Blastocyst-stage embryo transfer strategy | Experimental | Not described Receives: Procedure: Blastocyst-stage embryo transfer strategy |
| Cleavage-stage embryo transfer strategy | Active comparator | Not described Receives: Procedure: Cleavage-stage embryo transfer strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative live birth rate
Total number of births considering fresh and frozen thawed embryos transferred
Measured: at 12 months after a embryo transfer (time considered enough in order to do a minimum of one frozen-thawed cycle if pregnancy is not achieved with the fresh cycle
Secondary outcomes (1)
Cumulative pregnancy rate
Total number of pregnancies confirmed by ultrasound 6 weeks after embryo transfer including fresh and thawed embryos.
Measured: at 12 months after a embryo transfer (time considered enough in order to do a minimum of one frozen-thawed cycle if pregnancy is not achieved with the fresh cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2017
- Study start5 Apr 2017
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Why it stopped: Due to the clinically and statistically significant inferior results for the D3 group following evaluation by the institutional review board.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oocyte DonationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Dexeus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabet Clua Obrado, Fundacion Dexeus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03088735
- Sponsor's protocol ID
- SMD-2017-03
- Status last verified
- Jun 2021
- First submitted
- 18 Mar 2017
- Last updated
- 29 Jun 2021
- 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 29 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Best Transfer Strategy in an Oocyte Donation Programme: an Intention to Treat Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03088735
- Acronym / sponsor ID
- SMD-2017-03
- Conditions
- Oocyte Donation, Infertility, Female, Embryo Transfer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the clinically and statistically significant inferior results for the D3 group following evaluation by the institutional review board.
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Fundacion DexeusUniversity, hospital or other
- Study start
- 5 Apr 2017 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 23 Mar 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.
It has been previously shown that although the activation of the embryonic genome can begin as early as two days of initiation of the embryonic development (D2), it is expressed on day 3 (D3). Without this activation, the embryo can not continue its development. Therefore, it has been suggested that extended culture to blastocyst stage could be an option to identify and better select embryos that have been able to carry out this activation. The purpose of this study is to compare cumulative pregnancy and live birth rates following transfer of cleavage embryos or blastocysts.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blastocyst-stage embryo transfer strategy | Experimental | Procedure: Blastocyst-stage embryo transfer strategy |
| Cleavage-stage embryo transfer strategy | Active comparator | Procedure: Cleavage-stage embryo transfer strategy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients under their first or second cycle of a synchronous (fresh) oocyte donation cycle.
Key exclusion criteria (2 listed)
- Preimplantation genetic screening or diagnosis cycles.
- Patients with strict blastocyst-stage embryo transfer indication by the couple's treating physician.
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 |
|---|---|---|
| Blastocyst-stage embryo transfer strategyIntra-uterine transfer of blastocist if in cleavage embryo stage the oocyte recipient has a mínimum of 3 availables embryos with at least one of good quality to transfer and also the inta-uterine transfer of cleavage embryo (day 3) when the recipient doesn't have the previous criteria. | Procedure or surgery | Blastocyst-stage embryo transfer strategy |
| Cleavage-stage embryo transfer strategyInta-uterine transferring of cleavage embryo transfer (day 3 of develpment) in oocyte recipients | Procedure or surgery | Cleavage-stage embryo transfer strategy |
Primary outcome
Cumulative live birth rate
Time frame: at 12 months after a embryo transfer (time considered enough in order to do a minimum of one frozen-thawed cycle if pregnancy is not achieved with the fresh cycle
Total number of births considering fresh and frozen thawed embryos transferred
1 secondary outcome
Cumulative pregnancy rate
Time frame: at 12 months after a embryo transfer (time considered enough in order to do a minimum of one frozen-thawed cycle if pregnancy is not achieved with the fresh cycle
Results and safety
The study was stopped early (reason given: Due to the clinically and statistically significant inferior results for the D3 group following evaluation by the institutional review board.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2021.
- 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?
A study testing Blastocyst-stage embryo transfer strategy and Cleavage-stage embryo transfer strategy in people with Oocyte Donation and Infertility, Female, 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 1 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: stopped early, as of the sponsor's last update on 29 Jun 2021. 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 was stopped early (reason given: Due to the clinically and statistically significant inferior results for the D3 group following evaluation by the institutional review board.). Results are not available in the source record.
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?
Cumulative live birth rate (time frame: at 12 months after a embryo transfer (time considered enough in order to do a minimum of one frozen-thawed cycle if pregnancy is not achieved with the fresh cycle). 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 29 Jun 2021.