InfertilityPhase 3NCT02681029
The Clinical Outcomes Following Transfer of Blastocysts Cultured From Thawed Cleavage Stage Embryos
A Phase 3 study testing Blastocyte Transferring and Embryo Transferring in people with Infertility, run by Royan Institute at 1 site in Iran.
Trial summary
Recent improvements in cell culture systems have led to a shift in in vitro fertilization (IVF) practice from early cleavage stage embryo transfer (ET) to blastocyst transfer. Blastocyst culture and transfer could theoretically provide better synchronization between the embryo and the uterine endometrium. Read more about this study
- Who is it for?
- Ages 16 to 37 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Blastocyte Transferring and Embryo Transferring
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 1 siteIran
- Study dates
- Nov 2015to 27 Sep 2020
- Phase
- Phase 3
- 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 16 to 37 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- The patients with first type of infertility
- Age ≤ 37 years
- Long ovulation induction protocol
Who cannot join
- Any previous surgery on the uterus and ovaries
- Uterine factor infertility
- Sever Male factor infertility (TESE, TESA ،Oligoteratozoospermia)
- Recurrent abortion
- The women with poor ovarian reserve
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Clinical Outcomes Following Transfer of Blastocysts Cultured From Thawed Cleavage Stage Embryos at Royan Institute: A Phase 3, Randomized Controlled Trial
Recent improvements in cell culture systems have led to a shift in in vitro fertilization (IVF) practice from early cleavage stage embryo transfer (ET) to blastocyst transfer. Blastocyst culture and transfer could theoretically provide better synchronization between the embryo and the uterine endometrium. The purpose of this study is comparing pregnancy rates and implantation rate following transfer of thawed cleavage embryos and blastocysts cultured from thawed cleavage embryos.
Read the detailed description
The proposal of this study approved by our institutional review boards and institution's ethical committee, and all participants will sign a written consent before enter to study. All patients will be randomly divided into two groups of thawed cleavage embryo transfers and transfers of blastocysts from thawed cleavage embryos. Embryos will be transferred in hormone replacement cycles. Preparation of the endometrium will be started in the second day of menstruation and will be continued according to their transfer type (blastocyst or cleavage). βhCG will be assessed 14 days after embryo transfer. Treatment cycle outcomes will be compared between 2 groups.
- Conditions
- Infertility
- Being tested
- Blastocyte Transferring, Embryo Transferring
- Keywords
- Cleavage stage blastocyst transfer cryopreservation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blastocyte TransferringProcedure or surgery
Intra-uterine transferring of blastocyst from thawed cleavage embryo in infertile women.
Embryo TransferringProcedure or surgery
Inta-uterine transferring of thawed cleavage embryo transfer in infertile women.
| Study group | Role | What they receive |
|---|---|---|
| Blastocyst transplantation | Experimental | The infertile women who underwent intra- uterus transferring of blastocyst from thawed cleavage embryo Receives: Procedure: Blastocyte Transferring |
| Control | Placebo comparator | The infertile women who underwent intra- uterus transferring of thawed cleavage embryo. Receives: Procedure: Embryo Transferring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Rate
Evaluation of pregnancy rate in women 4 weeks after embryos transfer (ET).
Measured: 4weeks
Secondary outcomes (3)
Miscarriage Rate
Evaluation the miscarriage rate in women 14 days after embryo transfer (ET) with BHCG titration.
Measured: 14 days
Implantation Rate
Evaluation the implantation rate in women 14 days after embryo transfer (ET) with BHCG titration..
Measured: 14 days
Ongoing pregnancy rate
Evaluation the ongoing pregnancy rate in women 14 days after embryo transfer (ET) with BHCG titration..
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startNov 2015
- Primary completionJul 2020
- Study completion27 Sep 2020
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hamid Gourabi, PhD, Study chair, Head of Royan InstituteTahereh Madani, MD, Study director, Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, IranPoopak Eftekhari-Yazdi, PhD, Principal investigator, Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, IranNadia Jahangiri, MSc, Principal investigator, Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681029
- Sponsor's protocol ID
- Royan-Emb-023
- Status last verified
- Feb 2016
- First submitted
- 2 Feb 2016
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Madani T, Jahangiri N, Yahyaei A, Vesali S, Zarei M, Eftekhari-Yazdi P. Does The Culture of Post-Thawed Cleavage-Stage Embryos to Blastocysts Improve Infertility Treatment Outcomes of Frozen-Thawed Embryo Transfer Cycles? A Randomised Clinical Trial. Int J Fertil Steril. 2024 Feb 2;18(2):146-152. doi: 10.22074/ijfs.2023.560780.1357.
PubMed 38368518
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Clinical Outcomes Following Transfer of Blastocysts Cultured From Thawed Cleavage Stage Embryos at Royan Institute: A Phase 3, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02681029
- Acronym / sponsor ID
- Royan-Emb-023
- Conditions
- Infertility
- Keywords
- Cleavage stage blastocyst transfer cryopreservation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Royan InstituteOther government
- Study start
- Nov 2015
- Primary completion
- Jul 2020 (actual)
- Study completion
- 27 Sep 2020 (actual)
- First posted
- 12 Feb 2016 (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.
Recent improvements in cell culture systems have led to a shift in in vitro fertilization (IVF) practice from early cleavage stage embryo transfer (ET) to blastocyst transfer. Blastocyst culture and transfer could theoretically provide better synchronization between the embryo and the uterine endometrium. The purpose of this study is comparing pregnancy rates and implantation rate following transfer of thawed cleavage embryos and blastocysts cultured from thawed cleavage embryos.
Detailed description
The proposal of this study approved by our institutional review boards and institution's ethical committee, and all participants will sign a written consent before enter to study. All patients will be randomly divided into two groups of thawed cleavage embryo transfers and transfers of blastocysts from thawed cleavage embryos. Embryos will be transferred in hormone replacement cycles. Preparation of the endometrium will be started in the second day of menstruation and will be continued according to their transfer type (blastocyst or cleavage). βhCG will be assessed 14 days after embryo transfer. Treatment cycle outcomes will be compared between 2 groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blastocyst transplantation | Experimental | Procedure: Blastocyte TransferringThe infertile women who underwent intra- uterus transferring of blastocyst from thawed cleavage embryo |
| Control | Placebo comparator | Procedure: Embryo TransferringThe infertile women who underwent intra- uterus transferring of thawed cleavage embryo. |
Who may qualify
- Ages
- 16 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- The patients with first type of infertility
- Age ≤ 37 years
- Long ovulation induction protocol
Key exclusion criteria (5 listed)
- Any previous surgery on the uterus and ovaries
- Uterine factor infertility
- Sever Male factor infertility (TESE, TESA ،Oligoteratozoospermia)
- Recurrent abortion
- The women with poor ovarian reserve
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 |
|---|---|---|
| Blastocyte TransferringIntra-uterine transferring of blastocyst from thawed cleavage embryo in infertile women. | Procedure or surgery | Blastocyst transplantation |
| Embryo TransferringInta-uterine transferring of thawed cleavage embryo transfer in infertile women. | Procedure or surgery | Control |
Primary outcome
Pregnancy Rate
Time frame: 4weeks
Evaluation of pregnancy rate in women 4 weeks after embryos transfer (ET).
3 secondary outcomes
Miscarriage Rate
Time frame: 14 days
Implantation Rate
Time frame: 14 days
Ongoing pregnancy rate
Time frame: 14 days
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 12 May 2021.
- Derived from this study: PubMed 38368518Madani T, Jahangiri N, Yahyaei A, Vesali S, Zarei M, Eftekhari-Yazdi P. Does The Culture of Post-Thawed Cleavage-Stage Embryos to Blastocysts Improve Infertility Treatment Outcomes of Frozen-Thawed Embryo Transfer Cycles? A Randomised Clinical Trial. Int J Fertil Steril. 2024 Feb 2;18(2):146-152. doi: 10.22074/ijfs.2023.560780.1357.
- Related InfoLink provided by the sponsor.
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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.
Hamid Gourabi, PhD study chair
Head of Royan Institute
Tahereh Madani, MD study director
Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
Poopak Eftekhari-Yazdi, PhD principal investigator
Department of Endocrinology and Female Infertility, Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Blastocyte Transferring and Embryo Transferring in people with Infertility, run by Royan Institute at 1 site in Iran.
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 5 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 12 May 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 Iran. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pregnancy Rate (time frame: 4weeks). 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 NCT02681029, 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 12 May 2021.