InfertilityNCT04855669
Effect of Embryo Migration in Fresh Oocyte Donation Cycles
An observational study of Infertility, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Cyprus.
Trial summary
The investigators aimed to evaluate the impact of embryo distance from fundal endometrium, measured 60 minutes after transabdominal ultrasound guided embryo transfer(ET), on clinical pregnancy rates(CPR) and live birth rates(LBR) in fresh oocyte donation(OD) cycles. Read more about this study
- Who is it for?
- Ages 23 to 50 years, women only
- Conditions the study is for
- Infertility
- How many people
- 653 participants
- Where
- 1 siteCyprus
- Study dates
- 1 Jan 2016to 25 Jul 2021
- 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 23 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: The study included fresh OD cycles of recipient women.
Who may be able to join
- fresh oocyte donation cycles
- Anatomically anteverted-anteflexed recipient uterus
- partners with normal sperm parameters
Who cannot join
- Data of women who did not give approval
- IVF cycles
- frozen-thawed embryo transfer cycles
- cryopreserved-thawed OD cycles
- abnormal sperm parameters or need of any testicular interventions
- Anatomically retroverted-retroflexed recipient uterus
- teneculum required embryo transfers
- difficult transfers
Trial locations and contacts
1 site in 1 country.
Cyprus1 site, 1 recruiting
- Recruiting
Dunya In vitro fertilization center
Kyrenia
Alper Eraslan, M.D., +90 533 888 11 14, alpereraslan1984@gmail.com
About this study
Official title: Effect of Embryo Migration After Embryo Transfer With Fresh Oocyte Donation Cycles on Pregnancy Outcomes
The investigators aimed to evaluate the impact of embryo distance from fundal endometrium, measured 60 minutes after transabdominal ultrasound guided embryo transfer(ET), on clinical pregnancy rates(CPR) and live birth rates(LBR) in fresh oocyte donation(OD) cycles.
Read the detailed description
Embryos were considered to be staying at the initial expulsion site for long years. However, in 1976 Edwards and Steptoe reported a tubal ectopic pregnancy after in vitro fertilization (IVF) with a day-3 embryo transfer, which may be accepted as the earliest evidence for migration of embryos from the cavity. The migration concept is very recently taken into consideration by few authors, with studies on fresh IVF and frozen ET cycles.
Oocyte donation (OD) is a method of ART, in which by using young oocytes from donors the embryo quality is optimized. OD cycles have high LBRs, and are the choice of treatment in advanced reproductive age, repeated IVF failure, premature ovarian insufficiency(POI) and particular heritable genetic diseases. Donor oocytes can be used as fresh or cryoprotected-thawed, where fresh oocytes have higher LBRs.
In the literature, there are no studies performed in fresh OD cycles about air bubble and fundus distance after ET, and there are no studies performed whether there is any embryo migration after 60 minutes of ET and its effects on CPR and LBR.
Therefore, the investigators conducted this study to evaluate the impact of embryo distance from fundal endometrium, measured 60 minutes after transabdominal USG guided ET, on CPR and LBR in fresh OD cycles. In literature, this study is first to focus on embryo migration and LBR in fresh OD cycles.
- Conditions
- Infertility
- Keywords
- embryo migration, embryo transfer, fresh oocyte donation cycle, live birth rate
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
live birth rate
In the literature, there are no studies performed in fresh OD cycles about air bubble and fundus distance after ET, and there are no studies performed whether there is any embryo migration after 60 minutes of ET and its effects on live birth rate outcome.
Measured: 1 year
Secondary outcomes (1)
clinical pregnancy rate
In the literature, there are no studies performed in fresh OD cycles about air bubble and fundus distance after ET, and there are no studies performed whether there is any embryo migration after 60 minutes of ET and its effects on clinical pregnancy and miscarriage rate outcomes.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start1 Jan 2016
- Primary completion1 Jun 2021 (estimated)
- Study completion25 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 653 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Turkan Gursu, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855669
- Sponsor's protocol ID
- YDU/2020/86-1239
- Status last verified
- Apr 2021
- First submitted
- 18 Apr 2021
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After results are obtained we will decide.
Publications
Saravelos SH, Wong AW, Chan CP, Kong GW, Cheung LP, Chung CH, Chung JP, Li TC. Assessment of the embryo flash position and migration with 3D ultrasound within 60 min of embryo transfer. Hum Reprod. 2016 Mar;31(3):591-6. doi: 10.1093/humrep/dev343. Epub 2016 Jan 11.
PubMed 26759141Ficicioglu C, Ozcan P, Kocer MG, Yesiladali M, Alagoz O, Ozkara G, Tayyar AT, Altunok C. Effect of air bubbles localization and migration after embryo transfer on assisted reproductive technology outcome. Fertil Steril. 2018 Feb;109(2):310-314.e1. doi: 10.1016/j.fertnstert.2017.10.032. Epub 2018 Jan 4.
PubMed 29306491Ozdemir AZ, Ayas B, Guven D, Turkmen A. Embryo flash migration in fresh and frozen embryo transfers for day 3 and day 5 embryos. Eur J Obstet Gynecol Reprod Biol. 2019 Jul;238:33-37. doi: 10.1016/j.ejogrb.2019.04.025. Epub 2019 May 4.
PubMed 31082741
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Embryo Migration After Embryo Transfer With Fresh Oocyte Donation Cycles on Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT04855669
- Acronym / sponsor ID
- YDU/2020/86-1239
- Conditions
- Infertility
- Keywords
- embryo migration, embryo transfer, fresh oocyte donation cycle, live birth rate
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 653 participants (estimated)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 25 Jul 2021 (estimated)
- First posted
- 22 Apr 2021 (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 investigators aimed to evaluate the impact of embryo distance from fundal endometrium, measured 60 minutes after transabdominal ultrasound guided embryo transfer(ET), on clinical pregnancy rates(CPR) and live birth rates(LBR) in fresh oocyte donation(OD) cycles.
Detailed description
Embryos were considered to be staying at the initial expulsion site for long years. However, in 1976 Edwards and Steptoe reported a tubal ectopic pregnancy after in vitro fertilization (IVF) with a day-3 embryo transfer, which may be accepted as the earliest evidence for migration of embryos from the cavity. The migration concept is very recently taken into consideration by few authors, with studies on fresh IVF and frozen ET cycles.
Oocyte donation (OD) is a method of ART, in which by using young oocytes from donors the embryo quality is optimized. OD cycles have high LBRs, and are the choice of treatment in advanced reproductive age, repeated IVF failure, premature ovarian insufficiency(POI) and particular heritable genetic diseases. Donor oocytes can be used as fresh or cryoprotected-thawed, where fresh oocytes have higher LBRs.
In the literature, there are no studies performed in fresh OD cycles about air bubble and fundus distance after ET, and there are no studies performed whether there is any embryo migration after 60 minutes of ET and its effects on CPR and LBR.
Therefore, the investigators conducted this study to evaluate the impact of embryo distance from fundal endometrium, measured 60 minutes after transabdominal USG guided ET, on CPR and LBR in fresh OD cycles. In literature, this study is first to focus on embryo migration and LBR in fresh OD cycles.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 23 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study included fresh OD cycles of recipient women.
Key inclusion criteria (3 listed)
- fresh oocyte donation cycles
- Anatomically anteverted-anteflexed recipient uterus
- partners with normal sperm parameters
Key exclusion criteria (8 listed)
- Data of women who did not give approval
- IVF cycles
- frozen-thawed embryo transfer cycles
- cryopreserved-thawed OD cycles
- abnormal sperm parameters or need of any testicular interventions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
live birth rate
Time frame: 1 year
In the literature, there are no studies performed in fresh OD cycles about air bubble and fundus distance after ET, and there are no studies performed whether there is any embryo migration after 60 minutes of ET and its effects on live birth rate outcome.
1 secondary outcome
clinical pregnancy rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- Results publication: PubMed 26759141Saravelos SH, Wong AW, Chan CP, Kong GW, Cheung LP, Chung CH, Chung JP, Li TC. Assessment of the embryo flash position and migration with 3D ultrasound within 60 min of embryo transfer. Hum Reprod. 2016 Mar;31(3):591-6. doi: 10.1093/humrep/dev343. Epub 2016 Jan 11.
- Results publication: PubMed 29306491Ficicioglu C, Ozcan P, Kocer MG, Yesiladali M, Alagoz O, Ozkara G, Tayyar AT, Altunok C. Effect of air bubbles localization and migration after embryo transfer on assisted reproductive technology outcome. Fertil Steril. 2018 Feb;109(2):310-314.e1. doi: 10.1016/j.fertnstert.2017.10.032. Epub 2018 Jan 4.
- Results publication: PubMed 31082741Ozdemir AZ, Ayas B, Guven D, Turkmen A. Embryo flash migration in fresh and frozen embryo transfers for day 3 and day 5 embryos. Eur J Obstet Gynecol Reprod Biol. 2019 Jul;238:33-37. doi: 10.1016/j.ejogrb.2019.04.025. Epub 2019 May 4.
- Individual participant dataSharing planned: Undecided. After results are obtained we will decide.
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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.
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, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Cyprus.
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 8 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 22 Apr 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 Cyprus. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
live birth rate (time frame: 1 year). 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 NCT04855669, which also lists 3 linked publications.
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 22 Apr 2021.