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

2014-08-27 03:15:50 | BioPortfolio


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.


Endometrial assessments are proposed following three month and then nine month treatment with metformin; expression of specified markers at respective time points will be compared to baseline.

Visit 1: Screening

- Signed informed consent

- Comprehensive history intake

- Physical exam: Vital signs, height, weight, waist circumferences, waist : hip ratio

- Urine pregnancy test

- Subjects provided with a 10 day supply of vaginal progesterone and EMBx will be scheduled between days 6-8 of progesterone use.

Visit 2: Baseline

- Urine pregnancy test

- Endometrium thickness will be measured via transvaginal ultrasound

- EMBx: sample of endometrial tissue will be sent for histopathology to rule out endometrial hyperplasia or cancer

- 20cc blood

- Metformin prescription and dispensing will be as per clinical care.

- Women will be advised to use barrier method of contraception (ie; condoms, contraceptive jellies or foam, sponge, diaphragm, or cervical cap) for the duration of the study.

Visits 3 and 5 (Weeks 8-10 and 30-34, respectively)

- Urine pregnancy test

- A 10 day course of vaginal progesterone to allow scheduling of EMBx's time points specified under visit 1

Visits 4 and 6 (Weeks 12 ± 1 week and 36 ± 1 week respectively)

- The procedure specified for baseline (Visit 2) will be repeated.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Polycystic Ovarian Syndrome


Endometrin (progesterone 100mg vaginal inserts), Metformin


Yale-New Haven Hospital Women's Center
New Haven
United States




Yale University

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:15:50-0400

Clinical Trials [2630 Associated Clinical Trials listed on BioPortfolio]

Efficacy and Tolerability Study of Progesterone Vaginal Tablets (Endometrin®) in Menopausal Women Treated by Estrogen

The objective of the study is to confirm that the efficacy of vaginal progesterone is at least as good as oral progesterone in order to protect the endometrium of uncontrolled proliferati...

Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)

This multicenter, randomized, open-label exploratory study will be performed in approximately 200 PCOS but otherwise healthy females undergoing IVF. Each study center will follow its stan...

Metformin for Prevention Gestational Diabetes in Pregnant Women With Polycystic Ovarian Syndrome

Randomized, placebo controlled clinical trial that evaluate the role of taking metformin therapy during pregnancy in women with polycystic ovarian syndrome(PCOS) in reducing the developmen...

Combined Metformin and Clomiphene Citrate (CC) or Laparoscopic Ovarian Diathermy for Women With CC Resistant Polycystic Ovary Syndrome (PCOS)

The purpose of this study is to compare and determine the efficacy of combined metformin and Clomiphene citrate administration to that of laparoscopic ovarian diathermy (LOD) in infertile ...

Circulating Androgen Levels Are Not Affected by the Administration of Vaginal Micronized Progesterone for Withdrawal Bleeding in Patients With Polycystic Ovarian Syndrome

Hormonal evaluation of women who are suspected of having Polycystic ovary syndrome (PCOS) involves the measurement of basal levels of androgens and 17-hydroxyprogesterone (17-OHP), which a...

PubMed Articles [2192 Associated PubMed Articles listed on BioPortfolio]

Vaginal progesterone and the vaginal first-pass effect.

Vaginal progesterone is an effective alternative to systemic administration by oral or intramuscular use. The first-pass effect is reviewed, as are the most common uses for this route of delivery. Thi...

Effects of vaginal progesterone for maintenance tocolysis on uterine electrical activity.

The effectiveness of vaginal progesterone for maintenance tocolysis after arrested preterm labor remains controversial. Myometrial contractility can be assessed objectively and non-invasively after pr...

Metformin use in PCOS pregnancies increases the risk of offspring overweight at 4 years of age; follow-up of two RCTs.

Metformin is used in pregnancy in women with gestational diabetes mellitus, polycystic ovary syndrome (PCOS) and obesity. Metformin passes the placenta.

The numbers of 2- 5 and 6-9 mm ovarian follicles are inversely correlated in both normal women and in polycystic ovary syndrome patients: what is the missing link?

Is the negative correlation between the numbers of 2-5 and 6-9 mm follicles influenced by ovarian and/or metabolic parameter(s) in young control women and in patients with polycystic ovarian syndrome ...

Tumor necrosis factor alpha versus LH and androstendione as a reliable predictor of spontaneous ovulation after laparoscopic ovarian drilling for women with clomiphene citrate resistance polycystic ovarian disease.

Laparoscopic ovarian drilling (LOD) is still a controversial decision; due to the long term hazards; so short and long term predictors after the procedure should be taken in consideration. The aim of ...

Medical and Biotech [MESH] Definitions

A complex disorder characterized by infertility, HIRSUTISM; OBESITY; and various menstrual disturbances such as OLIGOMENORRHEA; AMENORRHEA; ANOVULATION. Polycystic ovary syndrome is usually associated with bilateral enlarged ovaries studded with atretic follicles, not with cysts. The term, polycystic ovary, is misleading.

Specific proteins found in or on cells of progesterone target tissues that specifically combine with progesterone. The cytosol progesterone-receptor complex then associates with the nucleic acids to initiate protein synthesis. There are two kinds of progesterone receptors, A and B. Both are induced by estrogen and have short half-lives.

Steroidal compounds related to PROGESTERONE, the major mammalian progestational hormone. Progesterone congeners include important progesterone precursors in the biosynthetic pathways, metabolites, derivatives, and synthetic steroids with progestational activities.

A biguanide hypoglycemic agent used in the treatment of non-insulin-dependent diabetes mellitus not responding to dietary modification. Metformin improves glycemic control by improving insulin sensitivity and decreasing intestinal absorption of glucose. (From Martindale, The Extra Pharmacopoeia, 30th ed, p289)

A pharmaceutical preparation of sitagliptin phosphate and metformin hydrochloride that is used in the treatment of TYPE 2 DIABETES.

More From BioPortfolio on "Endometrial Effects of Metformin Action in Women With Polycystic Ovarian Syndrome (PCOS)"

Quick Search


Relevant Topic

Women's Health
Women's Health - key topics include breast cancer, pregnancy, menopause, stroke Follow and track Women's Health News on BioPortfolio: Women's Health News RSS Women'...

Searches Linking to this Trial