NCT03086005

Brief Summary

This study was performed to investigate the effects of metformin on controlled ovarian stimulation (COS), in vitro fertilization (IVF) outcomes, pregnancy outcomes, and comparison of serum and follicular fluid cytokines and hormones in patients with polycystic ovary syndrome (PCOS) undergoing IVF using gonadotropin-releasing hormone(GnRH) antagonist protocol.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2011

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 12, 2011

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2015

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 22, 2017

Completed
Last Updated

May 11, 2017

Status Verified

May 1, 2017

Enrollment Period

3.6 years

First QC Date

February 15, 2017

Last Update Submit

May 10, 2017

Conditions

Polycystic Ovary Syndrome

Keywords

Metformin

Outcome Measures

Primary Outcomes (1)

  • Number of mature(MII) oocyte

    using polarized light microscopy

    Day1(from the day of oocyte retrieval to fertilization confirmation)

Secondary Outcomes (8)

  • Clinical pregnancy rate in %

    Pregnancy test was carried out at 11 days after embryo transfer and was classified as positive when the serum beta-human chorionic gonadotropin(hCG) level was over 5 IU/L. Than follow up to 12 weeks of gestation.

  • Miscarriage rate in %

    Pregnancy test was carried out at 11 days after embryo transfer and was classified as positive when the serum beta-human chorionic gonadotropin(hCG) level was over 5 IU/L. Than follow up to 20 weeks of gestation.

  • Total dose of follicle-stimulating hormone(FSH) used(IU)

    average of 10 days, From the day of stimulation start with FSH to the day of oocyte retrieval

  • Total duration of FSH used(day)

    average of 10 days, From the day of stimulation start with FSH to the day of oocyte retrieval

  • Number of oocytes retrieved

    Day1(the day of oocyte retrieval)

  • +3 more secondary outcomes

Study Arms (2)

Metformin

EXPERIMENTAL

Metformin 500mg tablet by mouth, every 12 hours, from the first day of oral contraceptive pills taken to the day of oocyte retrieval

Drug: Metformin

Placebo

PLACEBO COMPARATOR

Placebo(identical in appearance to metformin), every 12 hours, from the first day of oral contraceptive pills taken to the day of oocyte retrieval

Drug: Metformin

Interventions

MetforminDRUG
Also known as: Glucophage Tab 500mg, National Drug Code(NDC) 0087-6060-05
MetforminPlacebo

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • PCOS diagnostic criteria
  • American Society for Reproductive Medicine(ARSM)/European Society of Human Reproduction and Embryology(ESHRE) consensus meeting guideline
  • include two out of three
  • Oligo - or anovulation
  • Clinical or/and biochemical hyperandrogenism
  • Anatomical normal uterus
  • Normal level of thyroid hormone

You may not qualify if:

  • Severe endometriosis(stageIII, IV)
  • Endometrial thickness less than 7mm in late follicular phase
  • Severe male infertility factor, non-obstructive azoospermia
  • History of ectopic pregnancy or abortion over the last 3 months
  • Unexplained abnormal uterine bleeding
  • Congenital adrenal hyperplasia
  • Androgen secreting tumor
  • Cushing syndrome
  • Concurrent administration of metformin, ovulation induction drugs, oral contraceptives within previous 3 months
  • Chronic disease(liver, kidney, severe heart failure, DM)
  • Any pathology of genital tract
  • History of alcohol abuse
  • Refuse of study participate consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, Songpa-gu, 05505, South Korea

Location

Related Publications (8)

  • Thessaloniki ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Consensus on infertility treatment related to polycystic ovary syndrome. Hum Reprod. 2008 Mar;23(3):462-77. doi: 10.1093/humrep/dem426.

    PMID: 18308833BACKGROUND

  • Diamanti-Kandarakis E, Economou F, Palimeri S, Christakou C. Metformin in polycystic ovary syndrome. Ann N Y Acad Sci. 2010 Sep;1205:192-8. doi: 10.1111/j.1749-6632.2010.05679.x.

    PMID: 20840272BACKGROUND

  • Doldi N, Persico P, Di Sebastiano F, Marsiglio E, Ferrari A. Gonadotropin-releasing hormone antagonist and metformin for treatment of polycystic ovary syndrome patients undergoing in vitro fertilization-embryo transfer. Gynecol Endocrinol. 2006 May;22(5):235-8. doi: 10.1080/14767050600761893.

    PMID: 16785142BACKGROUND

  • Farrell K, Antoni MH. Insulin resistance, obesity, inflammation, and depression in polycystic ovary syndrome: biobehavioral mechanisms and interventions. Fertil Steril. 2010 Oct;94(5):1565-74. doi: 10.1016/j.fertnstert.2010.03.081. Epub 2010 May 14.

    PMID: 20471009BACKGROUND

  • Katsiki N, Hatzitolios AI. Insulin-sensitizing agents in the treatment of polycystic ovary syndrome: an update. Curr Opin Obstet Gynecol. 2010 Dec;22(6):466-76. doi: 10.1097/GCO.0b013e32833e1264.

    PMID: 20724929BACKGROUND

  • Toulis KA, Goulis DG, Farmakiotis D, Georgopoulos NA, Katsikis I, Tarlatzis BC, Papadimas I, Panidis D. Adiponectin levels in women with polycystic ovary syndrome: a systematic review and a meta-analysis. Hum Reprod Update. 2009 May-Jun;15(3):297-307. doi: 10.1093/humupd/dmp006. Epub 2009 Mar 4.

    PMID: 19261627BACKGROUND

  • Ardawi MS, Rouzi AA. Plasma adiponectin and insulin resistance in women with polycystic ovary syndrome. Fertil Steril. 2005 Jun;83(6):1708-16. doi: 10.1016/j.fertnstert.2004.11.077.

    PMID: 15950640BACKGROUND

  • 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: 33347618DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Metformin

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • CHUNG-HUN KIM, Professor

    Asan Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Asan Medical Center

Study Record Dates

First Submitted

February 15, 2017

First Posted

March 22, 2017

Study Start

October 12, 2011

Primary Completion

May 4, 2015

Study Completion

July 23, 2015

Last Updated

May 11, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)