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

NCT01233206 | Completed Phase 4 DMC

• 1 other identifier: 04/2010
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; Polycystic Ovary Syndrome (PCOS)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Rate of OHSS

  one month

Secondary Outcomes (9)

• Stimulation length

  one month

• Gonadotropins dose

  one month

• Dominant follicles on day of ovulation triggering

  one month

• Ovulation rate

  one month

• Peak estradiol levels on day of ovulation triggering

  one month

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients receiving metformin pretreatment and co-administration

Drug: Metformin

Control group

PLACEBO COMPARATOR

Placebo

Drug: Placebo administration

Interventions

Metformin DRUG

Metformin pre-treatment and co-administration

Experimental group

Placebo administration DRUG

Placebo pre-treatment and co-administration

Control group

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

Pugliese" Hospital

Catanzaro, 88100, Italy

Location

Related Publications (3)

• Palomba S, Falbo A, Orio F Jr, Manguso F, Russo T, Tolino A, Annamaria C, Dale B, Zullo F. A randomized controlled trial evaluating metformin pre-treatment and co-administration in non-obese insulin-resistant women with polycystic ovary syndrome treated with controlled ovarian stimulation plus timed intercourse or intrauterine insemination. Hum Reprod. 2005 Oct;20(10):2879-86. doi: 10.1093/humrep/dei130. Epub 2005 Jun 15.

  PMID: 15958399 BACKGROUND

• Tso LO, Costello MF, Albuquerque LET, Andriolo RB, Macedo CR. Metformin treatment before and during IVF or ICSI in women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2020 Dec 21;12(12):CD006105. doi: 10.1002/14651858.CD006105.pub4.

  PMID: 33347618 DERIVED

• Palomba S, Falbo A, Carrillo L, Villani MT, Orio F, Russo T, Di Cello A, Cappiello F, Capasso S, Tolino A, Colao A, Mastrantonio P, La Sala GB, Zullo F, Cittadini E; METformin in High Responder Italian Group. Metformin reduces risk of ovarian hyperstimulation syndrome in patients with polycystic ovary syndrome during gonadotropin-stimulated in vitro fertilization cycles: a randomized, controlled trial. Fertil Steril. 2011 Dec;96(6):1384-1390.e4. doi: 10.1016/j.fertnstert.2011.09.020. Epub 2011 Oct 7.

  PMID: 21982727 DERIVED

MeSH Terms

Conditions

Infertility; Polycystic Ovary Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Stefano Palomba

  University Magna Graecia

  PRINCIPAL INVESTIGATOR

• Fulvio Zullo

  University Magna Graecia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 8, 2010
• First Posted: November 3, 2010
• Study Start: May 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: January 1, 2011
• Last Updated: June 10, 2011

Record last verified: 2011-06

Locations

IT (1)