SubfertilityNCT02044445
Is the IVF Outcome Dependent on the Time Interval Between hCG Administration and Oocyte Retrieval?
A study testing Oocyte retrieval will be performed 36 h or 38 h after hCG administration in people with Subfertility, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
During controlled ovarian hyperstimulation (COH), human chorionic gonadotrophin (hCG) is administered to trigger the final follicular maturation before oocyte retrieval, in an attempt to mimic the physiologic effects of LH. The hCG is administered when more than three follicles ≥17mm in mean diameter have developed. Read more about this study
- Who is it for?
- Ages 20 to 43 years, women only
- Conditions the study is for
- Subfertility
- What is being tested?
- Oocyte retrieval will be performed 36 h or 38 h after hCG administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteGreece
- Study dates
- Nov 2009to Dec 2013
- 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 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women undergoing fresh IVF cycle with recombinant FSH and GnRH antagonists
- regular spontaneous menstrual cycle (24-35 days)
- age ≤ 43 years
- FSH ≤ 20 IU/L
Who cannot join
- History of previous ovarian surgery
- Women with Stage III-IV Endometriosis
- Women undergoing natural cycle IVF
Trial locations and contacts
1 site in 1 country.
Greece1 site
Unit for Human Reproduction, 1st Dept of Obstetrics and Gynaecology, Medical School, Aristotle University of Thessaloniki
Thessaloniki
About this study
During controlled ovarian hyperstimulation (COH), human chorionic gonadotrophin (hCG) is administered to trigger the final follicular maturation before oocyte retrieval, in an attempt to mimic the physiologic effects of LH. The hCG is administered when more than three follicles ≥17mm in mean diameter have developed.
The time interval between hCG administration and oocyte retrieval is of critical importance since the time after luteinizing stimulus is a period of intense processes including the start of luteinization, expansion of cumulus cells and oocyte meiotic maturation.
Read more
The commonly practiced hCG administration time of 33 to 36 h in most IVF cycles aims to avoiding spontaneous ovulation before oocyte retrieval. However, several studies have shown that significantly more high quality embryos have been obtained with a prolonged hCG-to-oocyte interval of 38 h. It has been hypothesized that longer interval would be beneficial in improving oocyte quality and achieving optimal maturation.
Currently there are no data on the effect of the time interval between hCG administration and oocyte retrieval on IVF outcome in GnRH antagonist cycles. The aim of this study is to determine whether there is any difference in in vitro fertilization outcome when oocyte retrieval takes place at 36 h or 38 h following hCG administration
- Conditions
- Subfertility
- Being tested
- Oocyte retrieval will be performed 36 h or 38 h after hCG administration
- Keywords
- IVF, hCG, oocyte retrieval, time interval
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oocyte retrieval will be performed 36 h or 38 h after hCG administrationProcedure or surgery
Also called oocyte retrieval at 36 hours following hCG administration, oocyte retrieval at 38 hours following hCG administration
Oocyte retrieval will be performed 36 h or 38 h after hCG administration
| Study group | Role | What they receive |
|---|---|---|
| 36 h group | Active comparator | Oocyte retrieval will be performed 36 hours after hCG administration Receives: Procedure: Oocyte retrieval will be performed 36 h or 38 h after hCG administration |
| 38 h group | Active comparator | Oocyte retrieval will be performed 38 hours after hCG administration Receives: Procedure: Oocyte retrieval will be performed 36 h or 38 h after hCG administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
retrieval rate (cumulus-oocyte complexes/ follicles> 11 mm)
Measured: up to 38 h after hCG administration
Secondary outcomes (2)
Clinical pregnancy rate (evidence of intrauterine sac with fetal heart activity at 6-8 weeks of gestation)
Measured: At 6-8 weeks of gestation
Total number of oocytes retrieved
Measured: up to 38 h after hCG administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startNov 2009
- Primary completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SubfertilityStudies 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
- Outcomes assessor
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, E.M. Kolibianakis, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044445
- Sponsor's protocol ID
- UHR-10
- Status last verified
- May 2014
- First submitted
- 10 Oct 2013
- Last updated
- 28 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is the IVF Outcome Dependent on the Time Interval Between hCG Administration and Oocyte Retrieval?
- ClinicalTrials.gov ID
- NCT02044445
- Acronym / sponsor ID
- UHR-10
- Conditions
- Subfertility
- Keywords
- IVF, hCG, oocyte retrieval, time interval
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2013 (actual)
- First posted
- 24 Jan 2014 (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.
During controlled ovarian hyperstimulation (COH), human chorionic gonadotrophin (hCG) is administered to trigger the final follicular maturation before oocyte retrieval, in an attempt to mimic the physiologic effects of LH. The hCG is administered when more than three follicles ≥17mm in mean diameter have developed.
The time interval between hCG administration and oocyte retrieval is of critical importance since the time after luteinizing stimulus is a period of intense processes including the start of luteinization, expansion of cumulus cells and oocyte meiotic maturation.
The commonly practiced hCG administration time of 33 to 36 h in most IVF cycles aims to avoiding spontaneous ovulation before oocyte retrieval. However, several studies have shown that significantly more high quality embryos have been obtained with a prolonged hCG-to-oocyte interval of 38 h. It has been hypothesized that longer interval would be beneficial in improving oocyte quality and achieving optimal maturation.
Currently there are no data on the effect of the time interval between hCG administration and oocyte retrieval on IVF outcome in GnRH antagonist cycles. The aim of this study is to determine whether there is any difference in in vitro fertilization outcome when oocyte retrieval takes place at 36 h or 38 h following hCG administration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 36 h group | Active comparator | Procedure: Oocyte retrieval will be performed 36 h or 38 h after hCG administrationOocyte retrieval will be performed 36 hours after hCG administration |
| 38 h group | Active comparator | Procedure: Oocyte retrieval will be performed 36 h or 38 h after hCG administrationOocyte retrieval will be performed 38 hours after hCG administration |
Who may qualify
- Ages
- 20 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- women undergoing fresh IVF cycle with recombinant FSH and GnRH antagonists
- regular spontaneous menstrual cycle (24-35 days)
- age ≤ 43 years
- FSH ≤ 20 IU/L
Key exclusion criteria (3 listed)
- History of previous ovarian surgery
- Women with Stage III-IV Endometriosis
- Women undergoing natural cycle IVF
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 |
|---|---|---|
| Oocyte retrieval will be performed 36 h or 38 h after hCG administrationAlso: oocyte retrieval at 36 hours following hCG administration, oocyte retrieval at 38 hours following hCG administrationOocyte retrieval will be performed 36 h or 38 h after hCG administration | Procedure or surgery | 36 h group, 38 h group |
Primary outcome
retrieval rate (cumulus-oocyte complexes/ follicles> 11 mm)
Time frame: up to 38 h after hCG administration
2 secondary outcomes
Clinical pregnancy rate (evidence of intrauterine sac with fetal heart activity at 6-8 weeks of gestation)
Time frame: At 6-8 weeks of gestation
Total number of oocytes retrieved
Time frame: up to 38 h after hCG administration
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 28 May 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oocyte retrieval will be performed 36 h or 38 h after hCG administration in people with Subfertility, run by Aristotle University Of Thessaloniki at 1 site in Greece.
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 4 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 28 May 2014. 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 Greece. 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?
retrieval rate (cumulus-oocyte complexes/ follicles> 11 mm) (time frame: up to 38 h after hCG administration). 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 28 May 2014.