Metformin in High Responder Polycystic Ovary Syndrome (PCOS) Patients Undergoing IVF Cycles
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01233206|
Recruitment Status : Completed
First Posted : November 3, 2010
Last Update Posted : June 10, 2011
The use of metformin pre-treatment and co-administration was recently proposed in infertile women affected by polycystic ovary syndrome (PCOS) treated with gonadotropins.
Data from meta-analyses showed that metformin administration significantly reduced the stimulation length and the total dose of gonadotropins used in PCOS women undergoing gonadotropins stimulation for non in-vitro fertilization (IVF) cycles. On the other hand, in IVF cycles metformin was demonstrated to significantly reduce the ovarian hyperstimulation syndrome (OHSS) rate in infertile patients with PCOS treated with gonadotropins.
The metformin regulating effect on the ovarian response was also observed in a randomized controlled trial (RCT) on young non-obese insulin-resistant women with PCOS receiving gonadotropins for mono-ovulation induction. In particular, metformin increased the mono-ovulatory cycles, the duration of stimulation and the amount of gonadotropins used, while it reduced the number of dominant follicles and the estradiol (E2) levels.
The aim of the present study was to evaluate the effect of metformin administration in high responder PCOS patients undergoing gonadotropins ovarian stimulation for IVF cycles.
|Condition or disease||Intervention/treatment||Phase|
|Infertility Polycystic Ovary Syndrome (PCOS)||Drug: Metformin Drug: Placebo administration||Phase 4|
Infertile young non-obese insulin-resistant patients with PCOS who had a background of the first IVF treatment cycle cancelled because of high risk for OHSS will be enrolled and randomized in two treatment arms.
In their second IVF attempt, the experimental group will receive metformin (500 mg, 3 times daily) pre-treatment for two weeks and co-administration during gonadotropins ovarian stimulation; the control group will be treated with placebo (2 cps daily) pre-treatment and co-administration by using the same schedule of the experimental group. In all patients, ovarian stimulation will be carried out with a personalized step-down gonadotropin in association with a minidose flare-up GnRH agonist protocol.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Metformin Addition to Gonadotropins Ovarian Stimulation in High Responder Patients With PCOS Undergoing In-vitro Fertilization|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||January 2011|
Experimental: Experimental group
Patients receiving metformin pretreatment and co-administration
Metformin pre-treatment and co-administration
Placebo Comparator: Control group
Drug: Placebo administration
Placebo pre-treatment and co-administration
- Rate of OHSS [ Time Frame: one month ]
- Stimulation length [ Time Frame: one month ]
- Gonadotropins dose [ Time Frame: one month ]
- Dominant follicles on day of ovulation triggering [ Time Frame: one month ]
- Ovulation rate [ Time Frame: one month ]
- Peak estradiol levels on day of ovulation triggering [ Time Frame: one month ]
- Embryo quality [ Time Frame: one month ]
- pregnancy rate [ Time Frame: one month ]
- multiple pregnancy rate [ Time Frame: one month ]
- Live birth rate [ Time Frame: ten months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01233206
|Catanzaro, Italy, 88100|
|Principal Investigator:||Stefano Palomba||University Magna Graecia|
|Study Chair:||Fulvio Zullo||University Magna Graecia|