InfertilityNCT01762111
AMH and Pregnancy Rate by Age During Stimulate In-Vitro Fertilization Protocol
An observational study of Infertility, run by Clinique Ovo at 1 site in Canada.
Trial summary
The woman fertility decrease with the age and there is a closely link with the ovarian reserve, the number of available eggs in the ovaries. Therefore, it is important to evaluate the ovarian reserve with specific marker to have a better prediction of the response of the in vitro fertilization treatment and to have a… Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Infertility
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2012to Dec 2013
- Phase
- Observational
- 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 18 to 43 years
- Women only
- No healthy volunteers
- Adult
Study population: Women followed at the clinique ovo, aged between 18 and 43 years old undergoing a stimulate In-Vitro Fertilization cycle.
Who may be able to join
- All infertile patients aged between 18 and 43 years
- Patients with a prescription for a stimulated In-Vitro Fertilization cycle
Who cannot join
- Presence of endocrine disease: diabetes, hyperprolactinemia, abnormal thyroid-stimulating hormone (TSH) or Cushing syndrome
- Renal or hepatic impairment known
Trial locations and contacts
1 site in 1 country.
About this study
The woman fertility decrease with the age and there is a closely link with the ovarian reserve, the number of available eggs in the ovaries. Therefore, it is important to evaluate the ovarian reserve with specific marker to have a better prediction of the response of the in vitro fertilization treatment and to have a better rate of pregnancy.
Until now, a lot of clinical criteria (age, duration of the infertility, number of antral follicles) and biological (FSH, Oestradiol, Inhibin B, EFFORT test, number of the eggs at the retrieval day) was suggested to help for the estimation of the ovarian reserve.
Read more
Since couple of years, the anti-müllerian hormone (AMH) is recognize to be one of the best ovarian reserve marker, it corresponding the number of antral follicles, it is more sensitive and predictive. Moreover, during the In-Vitro Fertilization, the anti-müllerian hormone can provide the weak responds at the stimulation and the reverse, the risk of excessive responds (hyperstimulation). To choose the gonadotropin doses to administrate (stimulation ovarian hormone) during an In-Vitro Fertilization protocol, we need to know the anti-müllerian hormone dosage. However, if the anti-müllerian hormone is recognize to evaluate the quantity of available eggs in the ovaries, his role to determine the quality of these eggs still discussed.
The goal of this study is to verify if the serum anti-müllerian hormone (blood) is a good indicator for the quality of the reserve ovarian evaluating the impact of anti-müllerian hormone rate on the pregnancy rate and implantation rate, during stimulate In-Vitro Fertilization protocol.
- Conditions
- Infertility
- Keywords
- Anti-Mullerian Hormone, In-Vitro fertilization
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rates
Clinical pregnancy rates per cycle and per transfer
Measured: 7 weeks
Secondary outcomes (3)
Cumulative pregnancy rates
Cumulative pregnancy rates including all frozen embryo transfer
Measured: 5 years
Number of eggs
Number of eggs retrieve at the end of the stimulated in-vitro fertilization cycle
Measured: 4 weeks
Number of embryos
Number of embryos obtain at the end of the stimulated in-vitro fertilization cycle
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: Recruitment difficulties
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Ovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacques Kadoch, MD, Principal investigator, Clinique Ovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01762111
- Sponsor's protocol ID
- OVO-12-22
- Status last verified
- Jan 2022
- First submitted
- 3 Jan 2013
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMH and Pregnancy Rate by Age During Stimulate In-Vitro Fertilization Protocol
- ClinicalTrials.gov ID
- NCT01762111
- Acronym / sponsor ID
- OVO-12-22
- Conditions
- Infertility
- Keywords
- Anti-Mullerian Hormone, In-Vitro fertilization
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Recruitment difficulties
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Clinique OvoIndustry (pharma, biotech, devices)
- Study start
- Dec 2012 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Jan 2013 (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 woman fertility decrease with the age and there is a closely link with the ovarian reserve, the number of available eggs in the ovaries. Therefore, it is important to evaluate the ovarian reserve with specific marker to have a better prediction of the response of the in vitro fertilization treatment and to have a better rate of pregnancy.
Until now, a lot of clinical criteria (age, duration of the infertility, number of antral follicles) and biological (FSH, Oestradiol, Inhibin B, EFFORT test, number of the eggs at the retrieval day) was suggested to help for the estimation of the ovarian reserve.
Since couple of years, the anti-müllerian hormone (AMH) is recognize to be one of the best ovarian reserve marker, it corresponding the number of antral follicles, it is more sensitive and predictive. Moreover, during the In-Vitro Fertilization, the anti-müllerian hormone can provide the weak responds at the stimulation and the reverse, the risk of excessive responds (hyperstimulation). To choose the gonadotropin doses to administrate (stimulation ovarian hormone) during an In-Vitro Fertilization protocol, we need to know the anti-müllerian hormone dosage. However, if the anti-müllerian hormone is recognize to evaluate the quantity of available eggs in the ovaries, his role to determine the quality of these eggs still discussed.
The goal of this study is to verify if the serum anti-müllerian hormone (blood) is a good indicator for the quality of the reserve ovarian evaluating the impact of anti-müllerian hormone rate on the pregnancy rate and implantation rate, during stimulate In-Vitro Fertilization protocol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women followed at the clinique ovo, aged between 18 and 43 years old undergoing a stimulate In-Vitro Fertilization cycle.
Key inclusion criteria (2 listed)
- All infertile patients aged between 18 and 43 years
- Patients with a prescription for a stimulated In-Vitro Fertilization cycle
Key exclusion criteria (2 listed)
- Presence of endocrine disease: diabetes, hyperprolactinemia, abnormal thyroid-stimulating hormone (TSH) or Cushing syndrome
- Renal or hepatic impairment known
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pregnancy rates
Time frame: 7 weeks
Clinical pregnancy rates per cycle and per transfer
3 secondary outcomes
Cumulative pregnancy rates
Time frame: 5 years
Number of eggs
Time frame: 4 weeks
Number of embryos
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
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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.
Jacques Kadoch, MD principal investigator
Clinique Ovo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Clinique Ovo at 1 site in Canada.
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 2 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: withdrawn, as of the sponsor's last update on 11 Jan 2022. 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 Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
Pregnancy rates (time frame: 7 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 11 Jan 2022.