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

Metformin Addition to Gonadotropins Ovarian Stimulation in High Responder Patients With PCOS Undergoing In-vitro Fertilization

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01233206
Enrollment
120
Registered
2010-11-03
Start date
2009-05-31
Completion date
2011-01-31
Last updated
2011-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Polycystic Ovary Syndrome (PCOS)

Keywords

PCOS, Polycystic ovary syndrome, Cancelled cycles, OHSS, Infertility

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.

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.

Interventions

DRUGMetformin

Metformin pre-treatment and co-administration

DRUGPlacebo administration

Placebo pre-treatment and co-administration

Sponsors

University Magna Graecia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Rate of OHSSone month

Secondary

MeasureTime frame
Ovulation rateone month
Gonadotropins doseone month
Stimulation lengthone month
Peak estradiol levels on day of ovulation triggeringone month
Dominant follicles on day of ovulation triggeringone month
pregnancy rateone month
multiple pregnancy rateone month
Live birth rateten months
Embryo qualityone month

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026