Endometrial Effects of Metformin Action in Women With Polycystic Ovarian Syndrome (PCOS)

NCT01070160 | Completed

• 2 other identifiers: 0905005203U54HD052668-02
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators aim is to conduct a prospective un-blinded pilot study of premenopausal women diagnosed with Polycystic Ovarian Syndrome (PCOS), defined using criteria developed at the 1990 NICHD conference on PCOS, undergoing treatment for ovulation induction with Metformin. We propose that improving insulin sensitivity with use of Metformin in women diagnosed with PCOS has facilitatory influences on the uterine endometrium.

Conditions

Polycystic Ovarian Syndrome

Keywords

Polycystic Ovarian Syndrome (PCOS); Metformin; Endometrin

Outcome Measures

Primary Outcomes (3)

• It is anticipated that endometrial expression of implantation markers will be upregulated by metformin treatment compared to baseline and improved parameters will be identified with longer duration of metformin exposure. endometrium biopsy

  baseline

• It is anticipated that endometrial expression of implantation markers will be upregulated by metformin treatment compared to baseline and improved parameters will be identified with longer duration of metformin exposure. endometrium biopsy

  3 months

• It is anticipated that endometrial expression of implantation markers will be upregulated by metformin treatment compared to baseline and improved parameters will be identified with longer duration of metformin exposure. endometrium biopsy

  9 months

Secondary Outcomes (2)

• blood draw (20mL)

  on day of EMBx

• A combination of quantitative real time PCR, immunohistochemistry, and Western Blot techniques will be utilized for studying endometrial markers of receptivity in the endometrial tissue

  9 months

Study Arms (3)

A

Women with PCOS initiating Metformin and exposure to vaginal progesterone for 6-8 days prior ro Endometrium Biopsy

Drug: Endometrin (progesterone 100mg vaginal inserts); Drug: Metformin

B

Women with PCOS not planning initiating Metformin and exposure to vaginal progesterone for 6-8 days prior to Endometrium Biopsy

Drug: Endometrin (progesterone 100mg vaginal inserts)

Women with PCOS who previously initiated metformin

Women with PCOS who initiated metformin at least 3 months prior to enrollment who have completed a 6-10 day course of progesterone

Interventions

Endometrin (progesterone 100mg vaginal inserts) DRUG

once a day, 6-8 days as specified (prior to each EMBx)

A; B

Metformin DRUG

per clinical care guidelines

A

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Women will be recruited from the multi-physician Yale Reproductive Endocrinology clinical practice and Yale Fertility Center. Metformin is a routinely employed therapeutic strategy utilized for managing PCOS by practitioners at YFC. Almost 1/3 of the patients with PCOS are not interested in pursuing fertility in the immediate future and it is these patients who will be offered participation in the trial.

You may qualify if:

• Premenopausal between 18-42 years of age
• Acceptable health on the basis of interview, medical history, physical examination, and laboratory tests (CBC, SMA20, urinalysis) performed within the past 6 months
• Able to provide signed informed consent
• Able to comply with study requirements
• Willing to delay the start of clinically prescribed metformin treatment

You may not qualify if:

• Known diabetics or those with clinically significant and known pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, neoplastic and malignant disease (other than non-melanoma skin cancer)
• Current use of hormonal contraceptives
• Seeking pregnancy; use of fertility drugs within 6 months of study
• Current or recent (within 3 months) use of metformin
• Ingestion of any investigational drug within two months prior to study onset
• Evidence of endometrial hyperplasia or cancer upon baseline EMBx

Sponsors & Collaborators

• Yale University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Yale-New Haven Hospital Women's Center

New Haven, Connecticut, 06520-8063, United States

Location

Related Links

• MedlinePlus related topics: Polycystic Ovary Disease
• Drug Information available for: Metformin

Biospecimen

Retention: SAMPLES WITH DNA

blood, endometrium tissue biopsy

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Progesterone; Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Lubna Pal, MBBS MRCOG MSc

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2010
• First Posted: February 17, 2010
• Study Start: June 1, 2009
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: March 30, 2020

Record last verified: 2014-06

Locations

US (1)