Antral Follicle DeficitNCT00231504
Study of Follicle Stimulating Hormone (FSH) Receptor in Women With Low Antral Follicle Count
An observational study of Antral Follicle Deficit and Fertility, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The deficit in the total number of antral follicles is associated with a reduction of the ovarian fertility potential in young women. The principal objective of this study is to evaluate the relationship between FSH receptor polymorphism and antral follicle count. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Antral Follicle Deficit, Fertility
- What is being tested?
- Blood samples
- Type of treatment
- Surgery or procedure
- How many people
- 82 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2005to May 2009
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: YOUNG WOMAN
Who may be able to join
- 18 to 35 years old
- 1 to 9 or 13 to 20 antral follicles
- Caucasian, occidental Europe
- Presence of both ovaries
- Informed consent
Who cannot join
- Ovarian anomalies
- Menopause
- Pregnancy
- Other diseases
Trial locations and contacts
1 site in 1 country.
France1 site
Antoine Beclere Hospital, Obstetrics and Gynaecology and Reproduction Medicine Service
Paris, 92140
About this study
The deficit in the total number of antral follicles is associated with a reduction of the ovarian fertility potential in young women.
The principal objective of this study is to evaluate the relationship between FSH receptor polymorphism and antral follicle count.
The investigators have designed a study of FSH receptor polymorphisms P1 and P2 as an association with a low antral follicle count in the ovary.
Read the detailed description
The present study will compare the prevalence of FSH receptor polymorphisms P1 and P2 in women having reduced follicle count (1 to 9 antral follicles) or normal follicle count (13 to 20 antral follicles) determined by ultrasound scans.
- Conditions
- Antral Follicle Deficit, Fertility
- Being tested
- Blood samples
- Keywords
- Polymorphism P1, Polymorphism P2, FSH Receptor, Antral follicle count, FSH receptor polymorphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesProcedure or surgery
Blood samples
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionMar 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antral Follicle DeficitStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Renato FANCHIN, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00231504
- Sponsor's protocol ID
- P041013
- Other IDs
- CRC04140
- Status last verified
- Mar 2007
- First submitted
- 3 Oct 2005
- Last updated
- 6 Jan 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Follicle Stimulating Hormone (FSH) Receptor in Women With Low Antral Follicle Count
- ClinicalTrials.gov ID
- NCT00231504
- Acronym / sponsor ID
- P041013
- Conditions
- Antral Follicle Deficit, Fertility
- Keywords
- Polymorphism P1, Polymorphism P2, FSH Receptor, Antral follicle count, FSH receptor polymorphism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Mar 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 4 Oct 2005 (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 deficit in the total number of antral follicles is associated with a reduction of the ovarian fertility potential in young women.
The principal objective of this study is to evaluate the relationship between FSH receptor polymorphism and antral follicle count.
The investigators have designed a study of FSH receptor polymorphisms P1 and P2 as an association with a low antral follicle count in the ovary.
Detailed description
The present study will compare the prevalence of FSH receptor polymorphisms P1 and P2 in women having reduced follicle count (1 to 9 antral follicles) or normal follicle count (13 to 20 antral follicles) determined by ultrasound scans.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- YOUNG WOMAN
Key inclusion criteria (5 listed)
- 18 to 35 years old
- 1 to 9 or 13 to 20 antral follicles
- Caucasian, occidental Europe
- Presence of both ovaries
- Informed consent
Key exclusion criteria (4 listed)
- Ovarian anomalies
- Menopause
- Pregnancy
- Other diseases
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 |
|---|---|---|
| Blood samplesBlood samples | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 6 Jan 2010.
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.
Renato FANCHIN, MD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Antral Follicle Deficit and Fertility, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 4 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 6 Jan 2010. 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 France. 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.
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 6 Jan 2010.