InfertilityNCT03113097
Does Transfer of Poor-quality Embryos With Good-quality Embryos Improve Pregnancy Outcome in Women Undergoing IVF/ICSI?
A study testing Embryo transfer in people with Infertility, run by Ain Shams University.
Trial summary
Women planned to undergo blastocyst-stage embryo transfer after IVF/ICSI were randomized into 2 groups: group I: women who had only good-quality embryo transfer. group II: women who had both good-quality and poor-quality embryo transfer. primary outcome was ongoing clinical pregnancy rate Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Embryo transfer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 627 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Mar 2017
- 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women undergoing primary IVF/ICSI cycles for tubal factor/unexplained infertility and had blastocyst-stage ET
Who cannot join
- cleavage-stage ET.
- women who had no good-quality embryos to transfer
- women who had known poor endometrial receptivity
About this study
Women planned to undergo blastocyst-stage embryo transfer after IVF/ICSI were randomized into 2 groups:
- group I: women who had only good-quality embryo transfer.
- group II: women who had both good-quality and poor-quality embryo transfer. primary outcome was ongoing clinical pregnancy rate
- Conditions
- Infertility
- Being tested
- Embryo transfer
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Embryo transferOther
Transfer of different qualities of embryos at blastocyst stage
| Study group | Role | What they receive |
|---|---|---|
| Good-quality embryo transfer | Active comparator | Women who had only good-quality embryo transfer Receives: Other: Embryo transfer |
| good- and poor-quality embryo transfer | Active comparator | Women who had both good- and poor-quality embryo transfer Receives: Other: Embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing clinical pregnancy rate
viable intrauterine pregnancy ongoing beyond 12 weeks of gestation
Measured: 12 weeks
Secondary outcomes (4)
Biochemical pregnancy rate
positive serum hCG
Measured: 2 weeks after ET
Clinical pregnancy rate
sonographic detection of viable intrauterine gestational sac
Measured: 4 weeks after ET
Multiple pregnancy rate
No. of intrauterine gestational sacs
Measured: 4-6 weeks after ET
Ectopic pregnancy rate
Extrauterine pregnancy
Measured: 6 weeks after ET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study startJun 2014
- Primary completionDec 2016
- Study completionMar 2017
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 627 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Dar El Teb Institute
- Responsible party
- Principal investigator, Mohammed Faris, Ain Shams University
- Investigators
- Mohammed Faris, MD, Principal investigator, Dar El Teb IVF and Infertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03113097
- Sponsor's protocol ID
- DAT-055
- Status last verified
- Apr 2017
- First submitted
- 10 Apr 2017
- Last updated
- 13 Apr 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Transfer of Poor-quality Embryos With Good-quality Embryos Improve Pregnancy Outcome in Women Undergoing IVF/ICSI?
- ClinicalTrials.gov ID
- NCT03113097
- Acronym / sponsor ID
- DAT-055
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 627 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Dar El Teb Institute
- Study start
- Jun 2014 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 13 Apr 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.
Women planned to undergo blastocyst-stage embryo transfer after IVF/ICSI were randomized into 2 groups:
- group I: women who had only good-quality embryo transfer.
- group II: women who had both good-quality and poor-quality embryo transfer. primary outcome was ongoing clinical pregnancy rate
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Good-quality embryo transfer | Active comparator | Other: Embryo transferWomen who had only good-quality embryo transfer |
| good- and poor-quality embryo transfer | Active comparator | Other: Embryo transferWomen who had both good- and poor-quality embryo transfer |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women undergoing primary IVF/ICSI cycles for tubal factor/unexplained infertility and had blastocyst-stage ET
Key exclusion criteria (3 listed)
- cleavage-stage ET.
- women who had no good-quality embryos to transfer
- women who had known poor endometrial receptivity
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 |
|---|---|---|
| Embryo transferTransfer of different qualities of embryos at blastocyst stage | Other | Good-quality embryo transfer, good- and poor-quality embryo transfer |
Primary outcome
Ongoing clinical pregnancy rate
Time frame: 12 weeks
viable intrauterine pregnancy ongoing beyond 12 weeks of gestation
4 secondary outcomes
Biochemical pregnancy rate
Time frame: 2 weeks after ET
Clinical pregnancy rate
Time frame: 4 weeks after ET
Multiple pregnancy rate
Time frame: 4-6 weeks after ET
Ectopic pregnancy rate
Time frame: 6 weeks after ET
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 13 Apr 2017.
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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.
Mohammed Faris, MD principal investigator
Dar El Teb IVF and Infertility Center
Questions about this trial
What is this clinical trial studying?
A study testing Embryo transfer in people with Infertility, run by Ain Shams University.
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 3 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 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Ongoing clinical pregnancy rate (time frame: 12 weeks). 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 13 Apr 2017.