Polycystic Ovary SyndromePhase 4PERCINGNCT00378729
Surgical Ovarian Drilling Versus Hormonal Treatment for Infertility Associated to PolyCystic Ovaries Syndrome (PCOS)
A Phase 4 study testing Metformin and FSHr and Ovarian drilling by FERTILOSCOPY in people with Polycystic Ovary Syndrome, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
PolysCsytic Ovaries Syndrome (PCOS) is the most frequent endocrinopathy. The first stage of infertility treatment is Clomiphene Citrate which leads to 50 % pregnancies. In case of failure, it is possible to propose surgical ovarian drilling or ovarian hyperstimulation with Intra Uterine Insemination (IUI) which lead… Read more about this study
- Who is it for?
- Ages 18 to 36 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- Metformin and FSHr and Ovarian drilling by FERTILOSCOPY
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2006to Oct 2011
- Phase
- Phase 4
- 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 36 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 36 years old
- Female patient with PCOS (Rotterdam criteria)
- Failure of treatment with Clomiphene Citrate
- Informed consent
- Female patient with medical assurance
- Patient in failure with PCOS and Clomiphene citrate
Who cannot join
- Female patient is over 36 years old
- Thyroid disease (4<TSH<0.3 mUI/L)
- Virilizing tumor
- FERTILOSCOPY non possible (Douglas cul de sac clinically fixed)
- Anormality of SPERMOGRAM (abnormal time of migration of survival)
- Prolactin > 1.5 N
Show all 10Show fewer
- Anormality of 17-OH Progesterone (<2 ng/mL)
- Fallopian tubes non permeable TMS< 5 Millions
- Female patient participant or have been participated to another clinical trial during the last month before the inclusion
- Female patient without medical assurance
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital Antoine Beclere
Clamart, 92170
Hervé FERNANDES, MD,PhD, +33(0)- 1 45 37 44 69, herve.fernandez@abc.aphp.fr
Hervé FERNANDEZ, MD
About this study
Official title: PERCING : Ovarian Drilling Versus Ovarian Stimulation + Intra Uterine Insemination (IUI) + Metformin in the PCOS (PolyCystic Ovaries Syndrome) Treatment
PolysCsytic Ovaries Syndrome (PCOS) is the most frequent endocrinopathy. The first stage of infertility treatment is Clomiphene Citrate which leads to 50 % pregnancies. In case of failure, it is possible to propose surgical ovarian drilling or ovarian hyperstimulation with Intra Uterine Insemination (IUI) which lead to 50% pregnancies each. However, surgical treatment could be associated to surgical complications, and medical treatment could be associated to ovarian hyperstimulation syndrome and/or multiple pregnancies.
The aim of this study is to compare the two treatments to demonstrate the equivalence of efficacy and the diminution of multiple pregnancies by the surgical treatments. After an ambulatory surgery we will observe the spontaneous fertility during 9 months. For the medical treatment, Metformin is proposed during 9 months associated with 3 cycles of ovarian hyperstimulation and IUI if the sperm is normal
Read the detailed description
PolysCsytic Ovaries Syndrome (PCOS) is the most frequent endocrinopathy. The first stage of infertility treatment is Clomiphene Citrate which leads to 50 % pregnancies. In case of failure, it is possible to propose surgical ovarian drilling or ovarian hyperstimulation with Intra Uterine Insemination (IUI) which lead to 50% pregnancies each. However, surgical treatment could be associated to surgical complications, and medical treatment could be associated to ovarian hyperstimulation syndrome and/or multiple pregnancies.
The aim of this study is to compare the two treatments to demonstrate the equivalence of efficacy and the diminution of multiple pregnancies by the surgical treatments. After an ambulatory surgery we will observe the spontaneous fertility during 9 months. For the medical treatment, Metformin is proposed during 9 months associated with 3 cycles of ovarian hyperstimulation and IUI if the sperm is normal Ovarian drilling will be performed by FERTILOSCOPY. 126 patients will be necessary in each group (with interval of equivalence : 10%).
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- Metformin and FSHr, Ovarian drilling by FERTILOSCOPY
- Keywords
- PCOS, FERTILOSCOPY, Ovarian hyperstimulation, Multiple pregnancies, Patient with PCOS (Rotterdam criteria), Failure of treatment with Clomiphene Citrate, Age between 18 and 36 years old, Spermogram must be normal, Permeability of Fallopian tubes
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin and FSHrDrug
Also called treatment for infertility
treatment for infertility
Ovarian drilling by FERTILOSCOPYProcedure or surgery
Also called surgical ovarian drilling
surgical ovarian drilling
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Not described Receives: Drug: Metformin and FSHr |
| B | Active comparator | Not described Receives: Procedure: Ovarian drilling by FERTILOSCOPY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the cumulative rate of on-going pregnancy (>12 weeks of amenorrhoea) obtained during 9 months of follow-up
Measured: during 9 months of follow-up
Secondary outcomes (5)
Evaluation of tolerance
Measured: during the study
Occurrence of multiple pregnancies
Measured: at the end of the study
Duration of the menstrual cycles and hormonal ovarian dosages
Measured: during the study
Occurrence of spontaneous miscarriages
Measured: at the end of the study
Body Mass Index with each visit
Measured: at each visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2006 (estimated)
- Study startOct 2006
- Primary completionOct 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Hopital Antoine Beclere, Hôpital Jean Verdier, Jean Rostand Intercommoned Hospital, Centre Hospitalier Universitaire, Amiens, University Hospital, Caen, University Hospital, Clermont-Ferrand, Lille Hospital : Jeanne de Flandre Hospital, University Hospital, Strasbourg, France, CMCO SIHCUS, Schiltingheim, Study and research center of sterility (Lyon)
- Responsible party
- Sponsor
- Investigators
- Hervé FERNANDEZ, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378729
- Sponsor's protocol ID
- P051008
- Acronym
- PERCING
- Status last verified
- Oct 2007
- First submitted
- 19 Sep 2006
- Last updated
- 4 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fernandez H, Watrelot A, Alby JD, Kadoch J, Gervaise A, deTayrac R, Frydman R. Fertility after ovarian drilling by transvaginal fertiloscopy for treatment of polycystic ovary syndrome. J Am Assoc Gynecol Laparosc. 2004 Aug;11(3):374-8. doi: 10.1016/s1074-3804(05)60054-0.
PubMed 15559352
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERCING : Ovarian Drilling Versus Ovarian Stimulation + Intra Uterine Insemination (IUI) + Metformin in the PCOS (PolyCystic Ovaries Syndrome) Treatment
- ClinicalTrials.gov ID
- NCT00378729
- Acronym / sponsor ID
- PERCING / P051008
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS, FERTILOSCOPY, Ovarian hyperstimulation, Multiple pregnancies, Patient with PCOS (Rotterdam criteria), Failure of treatment with Clomiphene Citrate, Age between 18 and 36 years old, Spermogram must be normal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Hopital Antoine Beclere, Hôpital Jean Verdier, Jean Rostand Intercommoned Hospital, Centre Hospitalier Universitaire, Amiens, University Hospital, Caen, University Hospital, Clermont-Ferrand, Lille Hospital : Jeanne de Flandre Hospital, University Hospital, Strasbourg, France, CMCO SIHCUS, Schiltingheim, Study and research center of sterility (Lyon)
- Study start
- Oct 2006
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 21 Sep 2006 (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.
PolysCsytic Ovaries Syndrome (PCOS) is the most frequent endocrinopathy. The first stage of infertility treatment is Clomiphene Citrate which leads to 50 % pregnancies. In case of failure, it is possible to propose surgical ovarian drilling or ovarian hyperstimulation with Intra Uterine Insemination (IUI) which lead to 50% pregnancies each. However, surgical treatment could be associated to surgical complications, and medical treatment could be associated to ovarian hyperstimulation syndrome and/or multiple pregnancies.
The aim of this study is to compare the two treatments to demonstrate the equivalence of efficacy and the diminution of multiple pregnancies by the surgical treatments. After an ambulatory surgery we will observe the spontaneous fertility during 9 months. For the medical treatment, Metformin is proposed during 9 months associated with 3 cycles of ovarian hyperstimulation and IUI if the sperm is normal
Detailed description
PolysCsytic Ovaries Syndrome (PCOS) is the most frequent endocrinopathy. The first stage of infertility treatment is Clomiphene Citrate which leads to 50 % pregnancies. In case of failure, it is possible to propose surgical ovarian drilling or ovarian hyperstimulation with Intra Uterine Insemination (IUI) which lead to 50% pregnancies each. However, surgical treatment could be associated to surgical complications, and medical treatment could be associated to ovarian hyperstimulation syndrome and/or multiple pregnancies.
The aim of this study is to compare the two treatments to demonstrate the equivalence of efficacy and the diminution of multiple pregnancies by the surgical treatments. After an ambulatory surgery we will observe the spontaneous fertility during 9 months. For the medical treatment, Metformin is proposed during 9 months associated with 3 cycles of ovarian hyperstimulation and IUI if the sperm is normal Ovarian drilling will be performed by FERTILOSCOPY. 126 patients will be necessary in each group (with interval of equivalence : 10%).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: Metformin and FSHr |
| B | Active comparator | Procedure: Ovarian drilling by FERTILOSCOPY |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age between 18 and 36 years old
- Female patient with PCOS (Rotterdam criteria)
- Failure of treatment with Clomiphene Citrate
- Informed consent
- Female patient with medical assurance
Key exclusion criteria (10 listed)
- Female patient is over 36 years old
- Thyroid disease (4<TSH<0.3 mUI/L)
- Virilizing tumor
- FERTILOSCOPY non possible (Douglas cul de sac clinically fixed)
- Anormality of SPERMOGRAM (abnormal time of migration of survival)
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 |
|---|---|---|
| Metformin and FSHrAlso: treatment for infertilitytreatment for infertility | Drug | A |
| Ovarian drilling by FERTILOSCOPYAlso: surgical ovarian drillingsurgical ovarian drilling | Procedure or surgery | B |
Primary outcome
Evaluation of the cumulative rate of on-going pregnancy (>12 weeks of amenorrhoea) obtained during 9 months of follow-up
Time frame: during 9 months of follow-up
5 secondary outcomes
Evaluation of tolerance
Time frame: during the study
Occurrence of multiple pregnancies
Time frame: at the end of the study
Duration of the menstrual cycles and hormonal ovarian dosages
Time frame: during the study
Occurrence of spontaneous miscarriages
Time frame: at the end of the study
Body Mass Index with each visit
Time frame: at each visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2011.
- Background: PubMed 15559352Fernandez H, Watrelot A, Alby JD, Kadoch J, Gervaise A, deTayrac R, Frydman R. Fertility after ovarian drilling by transvaginal fertiloscopy for treatment of polycystic ovary syndrome. J Am Assoc Gynecol Laparosc. 2004 Aug;11(3):374-8. doi: 10.1016/s1074-3804(05)60054-0.
Related trials for Polycystic Ovary Syndrome
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
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.
Hervé FERNANDEZ, MD,PhD 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?
A Phase 4 study testing Metformin and FSHr and Ovarian drilling by FERTILOSCOPY in people with Polycystic Ovary Syndrome, 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 6 inclusion and 10 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 4 Oct 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 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hervé FERNANDEZ, MD,PhD (+33(0)- 1 45 37 44 69, herve.fernandez@abc.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the cumulative rate of on-going pregnancy (>12 weeks of amenorrhoea) obtained during 9 months of follow-up (time frame: during 9 months of follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00378729, which also lists 1 linked publication.
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 4 Oct 2011.