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The aim of this work is to study the effect of metformin use for reducing early pregnancy loss in pregnant patients with Polycystic ovary syndrome (PCOS).
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age. PCOS produces symptoms in approximately 5 to 10% of women of reproductive age (12-45 years old) and is thought to be one of the leading causes of the female subfertility
In pregnant women with PCOS, does metformin use decreases the rate of early pregnancy loss?
-Research hypothesis: In Pregnant women with PCOS, metformin may reduce the rate of early pregnancy loss.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| metformin arm | Experimental | 83 patients will continue metformin until end of 1st trimester (14 weeks gestation) |
|
| control arm | Placebo Comparator | 83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | 83 patients will continue metformin until end of 1st trimester |
|
| Measure | Description | Time Frame |
|---|---|---|
| Miscarriage Rate | 6 months |
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Inclusion Criteria:
Age : 25 - 35.
Pregnant patients in their 1st trimester with history of infertility due to PCOS confirmed by at least 2 of the following criteria ( Rotterdam Criteria )
Non diabetic patients who received metformin along with other ovulation-inducing drugs prior to pregnancy.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmed M kotb, MD | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Ain Shams University | Cairo | Cairo Governorate | Egypt |
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| ID | Title | Description |
|---|---|---|
| FG000 | Metformin Arm | 83 patients will continue metformin until end of 1st trimester (14 weeks gestation) Metformin: 83 patients will continue metformin until end of 1st trimester |
| FG001 | Control Arm | 83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation) Metformin: 83 patients will continue metformin until end of 1st trimester |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Metformin Arm | 83 patients will continue metformin until end of 1st trimester (14 weeks gestation) Metformin: 83 patients will continue metformin until end of 1st trimester |
| BG001 | Control Arm |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Miscarriage Rate | Posted | Number | 95% Confidence Interval | participants | 6 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Metformin Arm | 83 patients will continue metformin until end of 1st trimester (14 weeks gestation) Metformin: 83 patients will continue metformin until end of 1st trimester |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ahmed kotb | AinShamsU | 1008681999 | +20 | ahmedmkotp@hotmail.com |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)
Metformin: 83 patients will continue metformin until end of 1st trimester
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 0 |
| 83 |
| 16 |
| 83 |
| EG001 | Control Arm | 83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation) Metformin: 83 patients will continue metformin until end of 1st trimester | 0 | 83 | 6 | 83 |
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| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |