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Completed

NCT Number: NCT01233206

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

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.

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Key information

Conditions

Infertility Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Polycystic Ovary Syndrome (PCOS) Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Pugliese" Hospital

Catanzaro, 88100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

metformin

Drug

Metformin pre-treatment and co-administration

Placebo Administration

Drug

Placebo pre-treatment and co-administration

Primary outcomes

  1. Rate of OHSS

    Time frame: one month

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Magna Graecia

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Nov 3, 2010
Registry last updated
Jun 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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