InfertilityNCT01205009
Human Chorionic Gonadotropin Supplementation Prior to In-vitro Fertilization Treatment in Poor Responders
A study testing Ovitrelle in people with Infertility, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
In an era of delayed fertility plans, there is increasing need for fertility treatment in older women with poor response. Human chorionic gonadotropin (hCG) supplementation prior to treatment, as a thecal stimulant, may improve folliculogenesis and ovarian response. Read more about this study
- Who is it for?
- Ages 40 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Ovitrelle
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2011to Mar 2012
- 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 40 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women >39 years on IVF treatment
Who cannot join
- polycystic ovary syndrome
- Any allergy to injection of human chorionic gonadotropin before
Trial locations and contacts
1 site in 1 country.
Mushira Aboo Dia,, MD contact
Israel1 site
Hadassah Medical Center
Jerusalem, Israel
Arik Tzukert, DMD, 0097226776095, arik@hadassah.org.il
Mushira Aboo Dia, MD, 0097226776425, mushiraa@gmail.com
About this study
In an era of delayed fertility plans, there is increasing need for fertility treatment in older women with poor response. Human chorionic gonadotropin (hCG) supplementation prior to treatment, as a thecal stimulant, may improve folliculogenesis and ovarian response.
- Conditions
- Infertility
- Being tested
- Ovitrelle
- Keywords
- in-vitro fertilization, poor responders, human chorionic gonadotropin, Fertility Agents, Female
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OvitrelleDrug
One dose of Ovitrelle 250 mcg
| Study group | Role | What they receive |
|---|---|---|
| Ovitrelle supplemantation | Active comparator | The women will be given 250 mcg of Ovitrelle prior to their IVF cycle Receives: Drug: Ovitrelle |
| no Ovitrelle supplementation | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of oocytes retrieved
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2010 (estimated)
- Study startApr 2011
- Primary completionMar 2012 (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.
- More trials run by Hadassah Medical OrganizationThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Mushira Aboo Dia, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01205009
- Sponsor's protocol ID
- hCGpoorresp-HMO-CTIL
- Status last verified
- Sep 2010
- First submitted
- 30 Aug 2010
- Last updated
- 2 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Chorionic Gonadotropin Supplementation Prior to In-vitro Fertilization Treatment in Poor Responders
- ClinicalTrials.gov ID
- NCT01205009
- Acronym / sponsor ID
- hCGpoorresp-HMO-CTIL
- Conditions
- Infertility
- Keywords
- in-vitro fertilization, poor responders, human chorionic gonadotropin, Fertility Agents, Female
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Mar 2012 (estimated)
- First posted
- 20 Sep 2010 (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.
In an era of delayed fertility plans, there is increasing need for fertility treatment in older women with poor response. Human chorionic gonadotropin (hCG) supplementation prior to treatment, as a thecal stimulant, may improve folliculogenesis and ovarian response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ovitrelle supplemantation | Active comparator | Drug: OvitrelleThe women will be given 250 mcg of Ovitrelle prior to their IVF cycle |
| no Ovitrelle supplementation | No intervention | – |
Who may qualify
- Ages
- 40 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women >39 years on IVF treatment
Key exclusion criteria (2 listed)
- polycystic ovary syndrome
- Any allergy to injection of human chorionic gonadotropin before
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 |
|---|---|---|
| OvitrelleOne dose of Ovitrelle 250 mcg | Drug | Ovitrelle supplemantation |
Primary outcome
number of oocytes retrieved
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2011.
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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.
Mushira Aboo Dia,, MD contact
Mushira Aboo Dia, MD principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ovitrelle in people with Infertility, run by Hadassah Medical Organization at 1 site in Israel.
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 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 2 Mar 2011. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mushira Aboo Dia,, MD (mushiraa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of oocytes retrieved (time frame: 1 month). 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 2 Mar 2011.