Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Diseases and Abnormalities at or Before Birth

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Diabetes Mellitus

Congenital Abnormalities

Polycystic Ovary Syndrome

Abortion, Spontaneous

Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Metformin

Insulin

Insulin, Globin Zinc

Pregnant women seeking counseling by themselves or through their healthcare provider for exposure to metformin (Anatomical Therapeutic Chemical A10BA02) any time during pregnancy (i. e. any time from conception to week 42 after last menstrual period (LMP)).

Pregnant women seeking counseling by themselves or through their healthcare provider for exposure to any drug not known as a major teratogen or fetotoxicant and different than metformin, insulin or any other hypoglycaemic agent.

This is not an intervention but an observed exposure.

metformin

any drug not known as a major teratogen or major fetotoxicant

This study aims to better characterize the risk linked to metformin use during pregnancy, using a prospective multicentric cohort design enabling a large sample size, in evaluating the rate of birth defects after first trimester exposure, as well as several other pregnancy related outcomes.

Safety of Metformin in Pregnancy

Pregnancy Outcome Following Maternal Exposure to Metformin: a Collaborative ENTIS Study

Centre Hospitalier Universitaire Vaudois

Senior research associate

Anti-Dyskinesia Agents

Cardiotonic Agents

Hormones

Cabergoline

Antiparkinson Agents

Dopamine

Dopamine Agonists

Dopamine Agents

Neurotransmitter Agents

25 Patients administered Metformin (Glucophage) Tablets of 500 mg per oral twice daily for 90 days duration.

25 Patients administered Cabergoline (Pergoline) Tablets of 0.5 mg dose per oral once weekly for 90 days duration.

25 Patients administered Metformin (Glucophage) Tablets of 500 mg per oral twice daily and Cabergoline (Pergoline) Tablets of 0.5 mg dose per oral once weekly for 90 days duration.

Brand name: (Glucophage) Tablets per oral / Twice daily / 90 days duration

Metformin Hydrochloride 500 MG

Brand name: (Pergoline) Tablets per oral / single dose per week / 90 days duration

Cabergoline 0.5 MG

Metformin Brand name: (Glucophage) Tablets per oral / Twice daily / 90 days duration

Cabergoline Brand name: (Pergoline) Tablets per oral / single dose per week / 90 days duration

Metformin Hydrochloride 500 MG + Cabergoline 0.5 MG

Inas Naser Hamad, B.Sc. Pharmacy

Sinaa Abdul Amir Kadhim, Ph.D Pharmacology

Hayder Adnan Fawzi, Ph.D Clinical Pharmacy

The goal of this interventional Randomized clinical is to compare the effect of Metformin alone, Cabergoline alone and Metformin and Cabergoline in combination in a sample of Iraqi female patients with polycystic ovary syndrome. The main questions to answer are:

1. What are the effects of the tested regimens on Body mass index (BMI)?
2. What are the effects of the tested regimens on hormonal status?
3. What are the effects of the tested regimens on uterine artery resistive index ?
4. What are the effects of the tested regimens on some inflammatory markers?

Participants will be separated into two groups:

1. Group 1 (M): 25 Patients, Received Metformin 500mg per oral twice daily for 90 days duration.
2. Group 2 (D): 25 Patients, Received Dostinex (Pergolin) 0.5 mg per oral (single dose per/week).
3. Group 3 (MD): 25 Pateins, Received metformin 500 mg per oral twice daily for 90 days duration and Dostinex (Pergolin) as 0.5 mg per oral (single dose per/week).

Researchers will compare Group 1 (M), Group 2 (D), Group 3 (MD) to observe the effect of the tested treatment regimens on Body Mass Index, Hormonal status, uterine artery resistive index, and some inflammatory markers that are IL-18, Anti-GAD Antibody and GnRH Antibody.

Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS

Measured in Kg/m² as a part of hormone status changes analysis

Measured in ng/mL as a part of hormone status changes analysis

Measured in mIU/mL as a part of hormone status changes analysis

Calculated by ultrasonography as a part of the ultrasonic analysis

Measured in ng/mL as a part of inflammatory markers analysis

Measured in pg/mL as a part of inflammatory markers analysis

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety of Metformin in Pregnancy	NCT02793505	Pregnancy Pregestational ... Polycystic Ovar...	metformin any drug not kn...	-	Centre Hospitalier Universitaire Vaudois
Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS	NCT05981742	Polycystic Ovar...	Metformin Hydro... Cabergoline 0.5... Metformin Hydro...	18 Years - 40 Years	Al-Rasheed University College
Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS	NCT05981742	Polycystic Ovar...	Metformin Hydro... Cabergoline 0.5... Metformin Hydro...	18 Years - 40 Years	Al-Rasheed University College

Spots Global Cancer Trial Database for polycystic ovary syndrom