AnovulationSOPKNCT00492882
Study of Mechanisms of Anovulation in Polycystic Ovary Syndrome
An observational study of Anovulation, run by University Hospital, Lille at 1 site in France.
Trial summary
We previously hypothesized that the excess of Anti-Mullerian Hormone (AMH) at the level of ovarian selectable follicles could be involved in the follicular arrest of Polycystic Ovary Syndrome (PCOS), mainly through inhibition of FSH effect on aromatase expression.In this study, we plan to investigate whether a drop in… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Anovulation
- What is being tested?
- usual administration of exogenous recombinant FSH
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2003to Jan 2007
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- normal sperm analysis in the partners and normal hysterosalpingography in all patients
- PCOS defined by Rotterdam criteria
- resistance to clomiphene citrate, i.e. no ovulation at 150 mg/day or no pregnancy after 6 ovulatory cycles
- informed consent before inclusion
Who cannot join
- on-going pregnancy
- age<18 or >40 yr.
- unability to understand the treatment protocol
- other medications
- any co-existent morbid condition contra-indicating a pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dynamic Changes in the Serum Anti-Müllerian Hormone Level During Low-dose recFSH Administration Further Support Its Role in the Anovulation of Polycystic Ovary Syndrome
We previously hypothesized that the excess of Anti-Mullerian Hormone (AMH) at the level of ovarian selectable follicles could be involved in the follicular arrest of Polycystic Ovary Syndrome (PCOS), mainly through inhibition of FSH effect on aromatase expression.In this study, we plan to investigate whether a drop in the serum AMH level would be concomitant to the appearance of a dominant follicle induced by administration of mild amounts of exogenous FSH in women with PCOS.
Read the detailed description
Women with PCOS (Rotterdam definition) whom anovulation is resistant to clomiphene citrate will receive recombinant FSH using the low-dose step-up protocol during only one cycle. Serum levels of estradiol, AMH, LH, FSH, inhibin B and ultrasound (U/S) parameters will be assessed twice a week until 3 days after appearance of > 1 dominant follicle(s).The starting dose of recFSH will be 50 IU/day. In the absence of criteria for dominance (see below) after 14 days at 50 IU/day, recFSH dose will be increased by 25 IU/day every 7 days until dominance is achieved. Dominance will be defined by the appearance of at least one follicle >10 mm growing at least 2 mm/day and serum E2> 100 pg/L. Ultrsound examination will performed with a 7-MHz transvaginal transducer (Sonoline Elegra, Siemens), in real time, according to a standardized protocol.Serum AMH levels will be assessed using the second-generation enzyme immunoassay AMH-EIA.
- Conditions
- Anovulation
- Being tested
- usual administration of exogenous recombinant FSH
- Keywords
- Polycystic Ovary Syndrome, Follicular Arrest, Anti-Mullerian Hormone, FSH
- Medical subject headings
- Anovulation, Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
usual administration of exogenous recombinant FSHDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2007 (estimated)
- Study startNov 2003
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AnovulationStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Organon
- Responsible party
- Sponsor
- Investigators
- Didier R DEWAILLY, MD, Study chair, University Hospital of Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00492882
- Sponsor's protocol ID
- CP03/102
- Acronym
- SOPK
- Status last verified
- Sep 2003
- First submitted
- 26 Jun 2007
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Desforges-Bullet V, Gallo C, Lefebvre C, Pigny P, Dewailly D, Catteau-Jonard S. Increased anti-Mullerian hormone and decreased FSH levels in follicular fluid obtained in women with polycystic ovaries at the time of follicle puncture for in vitro fertilization. Fertil Steril. 2010 Jun;94(1):198-204. doi: 10.1016/j.fertnstert.2009.03.004. Epub 2009 Apr 9.
PubMed 19361798Hamilton-Fairley D, Kiddy D, Watson H, Sagle M, Franks S. Low-dose gonadotrophin therapy for induction of ovulation in 100 women with polycystic ovary syndrome. Hum Reprod. 1991 Sep;6(8):1095-9. doi: 10.1093/oxfordjournals.humrep.a137491.
PubMed 1806568Pigny P, Jonard S, Robert Y, Dewailly D. Serum anti-Mullerian hormone as a surrogate for antral follicle count for definition of the polycystic ovary syndrome. J Clin Endocrinol Metab. 2006 Mar;91(3):941-5. doi: 10.1210/jc.2005-2076. Epub 2005 Dec 20.
PubMed 16368745
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Changes in the Serum Anti-Müllerian Hormone Level During Low-dose recFSH Administration Further Support Its Role in the Anovulation of Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT00492882
- Acronym / sponsor ID
- SOPK / CP03/102
- Conditions
- Anovulation
- Keywords
- Polycystic Ovary Syndrome, Follicular Arrest, Anti-Mullerian Hormone, FSH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Organon
- Study start
- Nov 2003
- Study completion
- Jan 2007 (actual)
- First posted
- 27 Jun 2007 (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.
We previously hypothesized that the excess of Anti-Mullerian Hormone (AMH) at the level of ovarian selectable follicles could be involved in the follicular arrest of Polycystic Ovary Syndrome (PCOS), mainly through inhibition of FSH effect on aromatase expression.In this study, we plan to investigate whether a drop in the serum AMH level would be concomitant to the appearance of a dominant follicle induced by administration of mild amounts of exogenous FSH in women with PCOS.
Detailed description
Women with PCOS (Rotterdam definition) whom anovulation is resistant to clomiphene citrate will receive recombinant FSH using the low-dose step-up protocol during only one cycle. Serum levels of estradiol, AMH, LH, FSH, inhibin B and ultrasound (U/S) parameters will be assessed twice a week until 3 days after appearance of > 1 dominant follicle(s).The starting dose of recFSH will be 50 IU/day. In the absence of criteria for dominance (see below) after 14 days at 50 IU/day, recFSH dose will be increased by 25 IU/day every 7 days until dominance is achieved. Dominance will be defined by the appearance of at least one follicle >10 mm growing at least 2 mm/day and serum E2> 100 pg/L. Ultrsound examination will performed with a 7-MHz transvaginal transducer (Sonoline Elegra, Siemens), in real time, according to a standardized protocol.Serum AMH levels will be assessed using the second-generation enzyme immunoassay AMH-EIA.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- normal sperm analysis in the partners and normal hysterosalpingography in all patients
- PCOS defined by Rotterdam criteria
- resistance to clomiphene citrate, i.e. no ovulation at 150 mg/day or no pregnancy after 6 ovulatory cycles
- informed consent before inclusion
Key exclusion criteria (5 listed)
- on-going pregnancy
- age<18 or >40 yr.
- unability to understand the treatment protocol
- other medications
- any co-existent morbid condition contra-indicating a pregnancy
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 |
|---|---|---|
| usual administration of exogenous recombinant FSH | Drug | – |
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 14 May 2026.
- Background: PubMed 19361798Desforges-Bullet V, Gallo C, Lefebvre C, Pigny P, Dewailly D, Catteau-Jonard S. Increased anti-Mullerian hormone and decreased FSH levels in follicular fluid obtained in women with polycystic ovaries at the time of follicle puncture for in vitro fertilization. Fertil Steril. 2010 Jun;94(1):198-204. doi: 10.1016/j.fertnstert.2009.03.004. Epub 2009 Apr 9.
- Background: PubMed 1806568Hamilton-Fairley D, Kiddy D, Watson H, Sagle M, Franks S. Low-dose gonadotrophin therapy for induction of ovulation in 100 women with polycystic ovary syndrome. Hum Reprod. 1991 Sep;6(8):1095-9. doi: 10.1093/oxfordjournals.humrep.a137491.
- Results publication: PubMed 16368745Pigny P, Jonard S, Robert Y, Dewailly D. Serum anti-Mullerian hormone as a surrogate for antral follicle count for definition of the polycystic ovary syndrome. J Clin Endocrinol Metab. 2006 Mar;91(3):941-5. doi: 10.1210/jc.2005-2076. Epub 2005 Dec 20.
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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.
Didier R DEWAILLY, MD study chair
University Hospital of Lille
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 Anovulation, run by University Hospital, Lille 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 4 inclusion and 5 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 14 May 2026. 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?
On the ClinicalTrials.gov record for NCT00492882, which also lists 3 linked publications.
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 14 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.