Surgical Ovarian Drilling Versus Hormonal Treatment for Infertility Associated to PolyCystic Ovar… (NCT00378729) | Clinical Trial Compass
UnknownPhase 4
Surgical Ovarian Drilling Versus Hormonal Treatment for Infertility Associated to PolyCystic Ovaries Syndrome (PCOS)
France252 participantsStarted 2006-10
Plain-language 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 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
Who can participate
Age range
18 Years – 36 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluation of the cumulative rate of on-going pregnancy (>12 weeks of amenorrhoea) obtained during 9 months of follow-up