Double-Embryo Transfer in ICSINCT05322278
Obstetric Outcomes After Double Embryo Transfer
An observational study of Double-Embryo Transfer in ICSI, run by Assiut University at 1 site in Egypt.
Trial summary
Aim ; to compare obstetric outcomes in relation to number of embryo transfer in ICSI Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Double-Embryo Transfer in ICSI
- What is being tested?
- Data collection
- How many people
- 927 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Mar 2022to 1 Mar 2024
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All women have ICSI at IVF unit at AUH
Who may be able to join
- all patients subjected with ICSI pregnancy
Who cannot join
- incomplete data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Obstetric Outcomes After Double Embryo Transfer in Intracytoplasmic Sperm Injection
Aim ; to compare obstetric outcomes in relation to number of embryo transfer in ICSI
Read the detailed description
Assisted reproductive technology with intracytoplasmic sperm injection (ICSI) and IVF is becoming an international direction for couples struggling with infertility. The increasing popularity and frequency of these techniques and the data generated from it has given us a better overview of the efficacy, consequences and costs of these techniques.
The aim of assisted reproductive technology (ART) is to achieve pregnancy while decreasing the risk of multiple gestations. When compared with elective single embryo transfer (SET), double embryo transfer (DET) demonstrates a superior pregnancy and live birth rate with a significantly higher risk of multiple gestations. The high frequency of multiple births is the main factor which leads to adverse outcome in IVF/intracytoplasmic sperm injection (ICSI) treatment. Transfer of two embryos does not diminish the chance of a birth when compared with three embryo transfer. How would be the obstetric outcome in pregnancies resulting from DET in IVF/ICSI cycles.
Despite achieving a higher pregnancy rates, DET in ART leads to an increase in multiple gestation pregnancies, which are associated with increased both maternal and neonatal morbidity and mortality.
Twin pregnancies have a higher incidence of preterm cesarean sections , admissions to the neonatal intensive care unit (NICU), and other maternal complications, when compared with singleton pregnancies. Twin pregnancies have a higher incidence of preterm cesarean sections , admissions to the neonatal intensive care unit (NICU), and other maternal complications, when compared with singleton pregnancies.
Most patients prefer to have two embryos transferred, due to financial considerations being the main reason.
Studies demonstrate that patients are more likely prefer to choose SET when educated about the risks of multiple gestation pregnancy, but select two embryos for transfer if they have a lower pregnancy rate when compared with transferring one embryo .
Cost effectiveness research comparing single versus DET after in vitro fertilization (IVF) has previously been performed, with most studies taking place in areas with mandated IVF insurance coverage, and few incorporating hospital costs linked to obstetrical and neonatal outcomes.
- Conditions
- Double-Embryo Transfer in ICSI
- Being tested
- Data collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
No interventions
| Study group | Role | What they receive |
|---|---|---|
| Single Embryo Transfer | Single Embryo Transfer Receives: Other: Data collection | |
| Double embryo transfer | Not described Receives: Other: Data collection | |
| 3 embryo transfer | Not described Receives: Other: Data collection | |
| 4 embryo transfer | Not described Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth
Comparison
Measured: 1 year
Secondary outcomes (8)
Rate of miscarriage
Comparison
Measured: 1 year
Rate of neonatal morbidities and mortalities in single embryo transfer versus double embryo transfer
Comparison
Measured: 1 year
Rate of admission to NICU
Comparison
Measured: 1 year
Rate of multiple pregnancies
Comparison
Measured: 1 year
Rate of preterm
Comparison
Measured: 1 year
Rate of PPROM
Comparison
Measured: 1 year
Rate of Clinical pregnancy
Comparison
Measured: 1 year
Rate of chemical pregnancy
Comparison
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 posted11 Apr 2022
- Study start30 Mar 2022
- Primary completion1 Nov 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Double-Embryo Transfer in ICSIStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 927 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Shehata Mohamed Ismail, Assiut University
- Investigators
- Sherif Mohamed Abd Elmageed Badran, Lecturer, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322278
- Sponsor's protocol ID
- DET in ICSI
- Status last verified
- Jun 2024
- First submitted
- 12 Dec 2021
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Clua E, Roca-Feliu M, Tresanchez M, Latre L, Rodriguez I, Martinez F, Barri PN, Veiga A. Single or double embryo transfer? Decision-making process in patients participating in an oocyte donation program. Gynecol Endocrinol. 2020 Apr;36(4):365-369. doi: 10.1080/09513590.2019.1653845. Epub 2019 Aug 29.
PubMed 31464145Gremeau AS, Brugnon F, Bouraoui Z, Peikhrishvili R, Janny L, Pouly JL. [Outcome of elective single or double embryo transfer in first and second IVF/ICSI cycles]. Gynecol Obstet Fertil. 2011 Feb;39(2):70-5. doi: 10.1016/j.gyobfe.2010.08.005. French.
PubMed 21316284
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Obstetric Outcomes After Double Embryo Transfer in Intracytoplasmic Sperm Injection
- ClinicalTrials.gov ID
- NCT05322278
- Acronym / sponsor ID
- DET in ICSI
- Conditions
- Double-Embryo Transfer in ICSI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 927 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 11 Apr 2022 (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.
Aim ; to compare obstetric outcomes in relation to number of embryo transfer in ICSI
Detailed description
Assisted reproductive technology with intracytoplasmic sperm injection (ICSI) and IVF is becoming an international direction for couples struggling with infertility. The increasing popularity and frequency of these techniques and the data generated from it has given us a better overview of the efficacy, consequences and costs of these techniques.
The aim of assisted reproductive technology (ART) is to achieve pregnancy while decreasing the risk of multiple gestations. When compared with elective single embryo transfer (SET), double embryo transfer (DET) demonstrates a superior pregnancy and live birth rate with a significantly higher risk of multiple gestations. The high frequency of multiple births is the main factor which leads to adverse outcome in IVF/intracytoplasmic sperm injection (ICSI) treatment. Transfer of two embryos does not diminish the chance of a birth when compared with three embryo transfer. How would be the obstetric outcome in pregnancies resulting from DET in IVF/ICSI cycles.
Despite achieving a higher pregnancy rates, DET in ART leads to an increase in multiple gestation pregnancies, which are associated with increased both maternal and neonatal morbidity and mortality.
Twin pregnancies have a higher incidence of preterm cesarean sections , admissions to the neonatal intensive care unit (NICU), and other maternal complications, when compared with singleton pregnancies. Twin pregnancies have a higher incidence of preterm cesarean sections , admissions to the neonatal intensive care unit (NICU), and other maternal complications, when compared with singleton pregnancies.
Most patients prefer to have two embryos transferred, due to financial considerations being the main reason.
Studies demonstrate that patients are more likely prefer to choose SET when educated about the risks of multiple gestation pregnancy, but select two embryos for transfer if they have a lower pregnancy rate when compared with transferring one embryo .
Cost effectiveness research comparing single versus DET after in vitro fertilization (IVF) has previously been performed, with most studies taking place in areas with mandated IVF insurance coverage, and few incorporating hospital costs linked to obstetrical and neonatal outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Single Embryo Transfer | – | Other: Data collectionSingle Embryo Transfer |
| Double embryo transfer | – | Other: Data collection |
| 3 embryo transfer | – | Other: Data collection |
| 4 embryo transfer | – | Other: Data collection |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All women have ICSI at IVF unit at AUH
Key inclusion criteria (1 listed)
- all patients subjected with ICSI pregnancy
Key exclusion criteria (1 listed)
- incomplete data
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 |
|---|---|---|
| Data collectionNo interventions | Other | 3 embryo transfer, 4 embryo transfer, Double embryo transfer, Single Embryo Transfer |
Primary outcome
Live birth
Time frame: 1 year
Comparison
8 secondary outcomes
Rate of miscarriage
Time frame: 1 year
Rate of neonatal morbidities and mortalities in single embryo transfer versus double embryo transfer
Time frame: 1 year
Rate of admission to NICU
Time frame: 1 year
Rate of multiple pregnancies
Time frame: 1 year
Rate of preterm
Time frame: 1 year
Rate of PPROM
Time frame: 1 year
Rate of Clinical pregnancy
Time frame: 1 year
Rate of chemical pregnancy
Time frame: 1 year
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 11 Jun 2024.
- Background: PubMed 31464145Clua E, Roca-Feliu M, Tresanchez M, Latre L, Rodriguez I, Martinez F, Barri PN, Veiga A. Single or double embryo transfer? Decision-making process in patients participating in an oocyte donation program. Gynecol Endocrinol. 2020 Apr;36(4):365-369. doi: 10.1080/09513590.2019.1653845. Epub 2019 Aug 29.
- Background: PubMed 21316284Gremeau AS, Brugnon F, Bouraoui Z, Peikhrishvili R, Janny L, Pouly JL. [Outcome of elective single or double embryo transfer in first and second IVF/ICSI cycles]. Gynecol Obstet Fertil. 2011 Feb;39(2):70-5. doi: 10.1016/j.gyobfe.2010.08.005. French.
- Individual participant dataSharing planned: Undecided
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.
Sherif Mohamed Abd Elmageed Badran, Lecturer study chair
Assiut University
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 Double-Embryo Transfer in ICSI, run by Assiut University at 1 site in Egypt.
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 11 Jun 2024. 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 Egypt. 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 (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 NCT05322278, which also lists 2 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 11 Jun 2024.