InfertilityDelOPUNCT02871154
Extending the hCG OPU Interval
A study testing Delaying oocyte pick up beyond 39 hours post hCG in people with Infertility, run by The Baruch Padeh Medical Center, Poriya.
Trial summary
Our and others experience suggest that in some cases delaying oocyte pick up (OPU) for more than 39 hours after hCG injection may be of benefit. We plan to apply this to 20 women in whom less than 20% of oocytes were found suitable for intracytoplasmic sperm injection. Read more about this study
- Who is it for?
- Ages 20 to 38 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Delaying oocyte pick up beyond 39 hours post hCG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2018
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- No previous IVF history
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Extending the Time Period Between the Injection of Chorionic Gonadotropin and Oocyte Pick-up as a Solution to Low Rate of Mature Oocyte and Poor Results in Assisted Reproduction
Our and others experience suggest that in some cases delaying oocyte pick up (OPU) for more than 39 hours after hCG injection may be of benefit.
We plan to apply this to 20 women in whom less than 20% of oocytes were found suitable for intracytoplasmic sperm injection. The delay will be for up to an interval of 47 hours from hCG to OPU.
Read the detailed description
In IVF one encounters some women in whom a low percentage of oocytes are found in the metaphase II stage upon their retrieval. Following some incidents, in our experience as well as others', where women injected hCG too early but oocytes were still retrieved with high proportion of maturity, we decided to delay OPU intentionally in women who had low percentage oocyte maturity in previous cycles.
- Conditions
- Infertility
- Being tested
- Delaying oocyte pick up beyond 39 hours post hCG
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delaying oocyte pick up beyond 39 hours post hCGOther
Unlike the traditional less-than 39 hours interval from hCG injection to oocyte pick up, we will extend the interval up to 47 hours
| Study group | Role | What they receive |
|---|---|---|
| Delay | Experimental | Delaying oocyte pick up beyond 39 hours post hCG Receives: Other: Delaying oocyte pick up beyond 39 hours post hCG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conception
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Baruch Padeh Medical Center, Poriya
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Odeh-L'ya Katz, PhD, Study director, Beruch Padeh Med Ctr Research Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02871154
- Sponsor's protocol ID
- 0041-16-POR
- Acronym
- DelOPU
- Status last verified
- Aug 2016
- First submitted
- 14 Aug 2016
- Last updated
- 18 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Study results
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extending the Time Period Between the Injection of Chorionic Gonadotropin and Oocyte Pick-up as a Solution to Low Rate of Mature Oocyte and Poor Results in Assisted Reproduction
- ClinicalTrials.gov ID
- NCT02871154
- Acronym / sponsor ID
- DelOPU / 0041-16-POR
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Baruch Padeh Medical Center, PoriyaOther government
- Study start
- Jan 2017
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 18 Aug 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.
Our and others experience suggest that in some cases delaying oocyte pick up (OPU) for more than 39 hours after hCG injection may be of benefit.
We plan to apply this to 20 women in whom less than 20% of oocytes were found suitable for intracytoplasmic sperm injection. The delay will be for up to an interval of 47 hours from hCG to OPU.
Detailed description
In IVF one encounters some women in whom a low percentage of oocytes are found in the metaphase II stage upon their retrieval. Following some incidents, in our experience as well as others', where women injected hCG too early but oocytes were still retrieved with high proportion of maturity, we decided to delay OPU intentionally in women who had low percentage oocyte maturity in previous cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Delay | Experimental | Other: Delaying oocyte pick up beyond 39 hours post hCGDelaying oocyte pick up beyond 39 hours post hCG |
Who may qualify
- Ages
- 20 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- No previous IVF history
- -
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 |
|---|---|---|
| Delaying oocyte pick up beyond 39 hours post hCGUnlike the traditional less-than 39 hours interval from hCG injection to oocyte pick up, we will extend the interval up to 47 hours | Other | Delay |
Primary outcome
Conception
Time frame: Two years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2016.
- Individual participant dataSharing planned: Yes. Study results
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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.
Odeh-L'ya Katz, PhD study director
Beruch Padeh Med Ctr Research Authority
Questions about this trial
What is this clinical trial studying?
A study testing Delaying oocyte pick up beyond 39 hours post hCG in people with Infertility, run by The Baruch Padeh Medical Center, Poriya.
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 0 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: status not confirmed, as of the sponsor's last update on 18 Aug 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Izhar Ben Shlomo, MD (972-52-6124781, ibenshlomo@poria.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conception (time frame: Two years). 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 18 Aug 2016.