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Metformin in High Responder Polycystic Ovary Syndrome (PCOS) Patients Undergoing IVF Cycles

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ClinicalTrials.gov Identifier: NCT01233206
Recruitment Status : Completed
First Posted : November 3, 2010
Last Update Posted : June 10, 2011
Sponsor:
Information provided by:
University Magna Graecia

Brief Summary:

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

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Experimental group
Patients receiving metformin pretreatment and co-administration
Drug: Metformin
Metformin pre-treatment and co-administration
Placebo Comparator: Control group
Placebo
Drug: Placebo administration
Placebo pre-treatment and co-administration



Primary Outcome Measures :
  1. Rate of OHSS [ Time Frame: one month ]

Secondary Outcome Measures :
  1. Stimulation length [ Time Frame: one month ]
  2. Gonadotropins dose [ Time Frame: one month ]
  3. Dominant follicles on day of ovulation triggering [ Time Frame: one month ]
  4. Ovulation rate [ Time Frame: one month ]
  5. Peak estradiol levels on day of ovulation triggering [ Time Frame: one month ]
  6. Embryo quality [ Time Frame: one month ]
  7. pregnancy rate [ Time Frame: one month ]
  8. multiple pregnancy rate [ Time Frame: one month ]
  9. Live birth rate [ Time Frame: ten months ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of one previous cancelled cycle for high-risk of OHSS, or history of moderate/severe OHSS during their previous IVF cycle
  • Infertility
  • Polycystic ovary syndrome (PCOS)
  • insulin resistance
  • hyperandrogenism

Exclusion Criteria:

  • BMI>30 kg/m2
  • age >35 years
  • FSH>9UI/L

Information from the National Library of Medicine

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


Locations
Italy
Pugliese" Hospital
Catanzaro, Italy, 88100
Sponsors and Collaborators
University Magna Graecia
Investigators
Principal Investigator: Stefano Palomba University Magna Graecia
Study Chair: Fulvio Zullo University Magna Graecia

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of Obstetrics and Gynecology, University Magna Graecia
ClinicalTrials.gov Identifier: NCT01233206     History of Changes
Other Study ID Numbers: 04/2010
First Posted: November 3, 2010    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: June 2011

Keywords provided by University Magna Graecia:
PCOS
Polycystic ovary syndrome
Cancelled cycles
OHSS
Infertility

Additional relevant MeSH terms:
Syndrome
Infertility
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Genital Diseases, Male
Genital Diseases, Female
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs