InfertilityPhase 1/2NCT01319708
Mild Versus Conventional Ovarian Stimulation for Poor Responders Undergoing In Vitro Fertilisation
A Phase 1/2 study testing mild ovarian stimulation and conventional ovarian stimulation in people with Infertility, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial summary
The investigators will examine the balance between IVF success in terms of outcome parameters, using a mild ovarian stimulation protocol, opposing it to the conventional stimulation regimens in poor responders undergoing IVF. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- mild ovarian stimulation and conventional ovarian stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- Mar 2011to Sep 2015
- Phase
- Phase 1/2
- 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 25 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- poor responders (age>40, previous POR, abnormal OR test)
- indication for IVF
- regular cycling patients
- BMI 19-35
Who cannot join
- contraindication for clomiphene citrate use or to GnRH agonists antagonists
- BMI > 35
Trial locations and contacts
1 site in 1 country.
Greece1 site
3rd Department of Obstetrics & Gynecology, Assisted Reproduction Unit
Athens, Chaidari, 12462
About this study
The investigators will examine the balance between IVF success in terms of outcome parameters, using a mild ovarian stimulation protocol, opposing it to the conventional stimulation regimens in poor responders undergoing IVF.
- Conditions
- Infertility
- Being tested
- mild ovarian stimulation, conventional ovarian stimulation
- Keywords
- ovarian stimulation, climiphene citrate, Gonadotropin-Releasing Hormone agonists/antagonists, Follicle Stimulating Hormone
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mild ovarian stimulationProcedure or surgery
100-150 mg of clomiphene citrate from day 2 till day 6 of the cycle and 150 mg of gonadotrophins as soon as 1 follicle is more than 14mm together with 1 fixed dose of GnRH antagonist until egg recovery
conventional ovarian stimulationProcedure or surgery
300-450 IU of FSH starting by day 2 of menstrual cycle together with a fixed dose of GnRH antagonist starting by day 6 till egg recovery, or same doses with GnRH agonist long protocol
| Study group | Role | What they receive |
|---|---|---|
| mild ovarian stimulation | Experimental | 100 mg CC by day 2 till 6, plus antagonist plus gonadotrophin 150-200IO until HCG triggering Receives: Procedure: mild ovarian stimulation |
| conventional ovarian stimulation | Active comparator | 300-450 IU of FSH starting by day 2 of menstrual cycle together with a fixed dose of GnRH antagonist starting by day 6 till egg recovery, or same doses using a GnRH agonist long protocol Receives: Procedure: conventional ovarian stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of oocytes (COCs)
Measured: at oocyte recovery
Secondary outcomes (6)
Number/rate of participants whom the IVF cycle was cancelled
Measured: After the 1st week of ovarian stimulation, no oocytes at OR
clinical pregnancy rate
Presence of fetal heart at transvaginal ultrasound at 6 weeks of gestation or 6 weeks after starting the intervention
Measured: 6 weeks
live birth
Measured: more than 20 weeks
miscarriage
Measured: pregnancy loss before 20 weeks of gestation, after a positive pregnancy test
stimulation characteristics
total dose of gonadotropins administered,
Measured: from start of stimulation until embryo transfer
cancellation rate
when premature ovulation was evident by the loss of follicle(s) prior to oocyte recovery, and in cases where there were no oocytes retrieved or no embryos produced for transfer and in failed fertilization
Measured: from start of stimulation until ET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionSep 2015
- Study completionSep 2015
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.
- More trials run by National and Kapodistrian University of AthensThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319708
- Sponsor's protocol ID
- 1234561
- Status last verified
- Nov 2015
- First submitted
- 8 Mar 2011
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mild Versus Conventional Ovarian Stimulation for Poor Responders Undergoing In Vitro Fertilisation
- ClinicalTrials.gov ID
- NCT01319708
- Acronym / sponsor ID
- 1234561
- Conditions
- Infertility
- Keywords
- ovarian stimulation, climiphene citrate, Gonadotropin-Releasing Hormone agonists/antagonists, Follicle Stimulating Hormone
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 22 Mar 2011 (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.
The investigators will examine the balance between IVF success in terms of outcome parameters, using a mild ovarian stimulation protocol, opposing it to the conventional stimulation regimens in poor responders undergoing IVF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mild ovarian stimulation | Experimental | Procedure: mild ovarian stimulation100 mg CC by day 2 till 6, plus antagonist plus gonadotrophin 150-200IO until HCG triggering |
| conventional ovarian stimulation | Active comparator | Procedure: conventional ovarian stimulation300-450 IU of FSH starting by day 2 of menstrual cycle together with a fixed dose of GnRH antagonist starting by day 6 till egg recovery, or same doses using a GnRH agonist long protocol |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- poor responders (age>40, previous POR, abnormal OR test)
- indication for IVF
- regular cycling patients
- BMI 19-35
Key exclusion criteria (2 listed)
- contraindication for clomiphene citrate use or to GnRH agonists antagonists
- BMI > 35
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 |
|---|---|---|
| mild ovarian stimulation100-150 mg of clomiphene citrate from day 2 till day 6 of the cycle and 150 mg of gonadotrophins as soon as 1 follicle is more than 14mm together with 1 fixed dose of GnRH antagonist until egg recovery | Procedure or surgery | mild ovarian stimulation |
| conventional ovarian stimulation300-450 IU of FSH starting by day 2 of menstrual cycle together with a fixed dose of GnRH antagonist starting by day 6 till egg recovery, or same doses with GnRH agonist long protocol | Procedure or surgery | conventional ovarian stimulation |
Primary outcome
number of oocytes (COCs)
Time frame: at oocyte recovery
6 secondary outcomes
Number/rate of participants whom the IVF cycle was cancelled
Time frame: After the 1st week of ovarian stimulation, no oocytes at OR
clinical pregnancy rate
Time frame: 6 weeks
live birth
Time frame: more than 20 weeks
miscarriage
Time frame: pregnancy loss before 20 weeks of gestation, after a positive pregnancy test
stimulation characteristics
Time frame: from start of stimulation until embryo transfer
cancellation rate
Time frame: from start of stimulation until 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 10 Nov 2015.
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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 Phase 1/2 study testing mild ovarian stimulation and conventional ovarian stimulation in people with Infertility, run by National and Kapodistrian University of Athens 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 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: finished, as of the sponsor's last update on 10 Nov 2015. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
number of oocytes (COCs) (time frame: at oocyte recovery). 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 10 Nov 2015.