Polycystic Ovary Syndrome
Conditions
Brief summary
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).
Detailed description
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 * The aim of this work is to study the effect of metformin use for reducing early pregnancy loss in pregnant patients with PCOS * Research question: 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.
Interventions
DRUGMetformin
83 patients will continue metformin until end of 1st trimester
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 35 Years
Healthy volunteers
Yes
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 ) * At least twelve small follicles 2-9 mm in at least one ovary; diagnosed by ultra sound examination. * Symptoms or biochemical evidence of hyperandrogenism; diagnosed by examination and laboratory investigations. * Anovulation or oligo-ovulation with fewer than nine menstrual periods every 12 months : diagnosed by thorough history taking. * Non diabetic patients who received metformin along with other ovulation-inducing drugs prior to pregnancy.
Exclusion criteria
* patients with other causes of infertility other than PCOS * contraindications to metformin : liver impairment , renal failure. * Patients with PCOS who didn't receive Metformin with drugs of induction of ovulation before pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Miscarriage Rate | 6 months |
Countries
Egypt
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 83 |
| 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 | 83 |
| Total | 166 |
Baseline characteristics
| Characteristic | Control Arm | Metformin Arm | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 83 Participants | 83 Participants | 166 Participants |
| Age, Continuous | 30.1 years STANDARD_DEVIATION 1.9 | 30.2 years STANDARD_DEVIATION 1.6 | 30.1 years STANDARD_DEVIATION 1.7 |
| Region of Enrollment Egypt | 83 participants | 83 participants | 166 participants |
| Sex: Female, Male Female | 83 Participants | 83 Participants | 166 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 83 | 6 / 83 |
| serious Total, serious adverse events | 0 / 83 | 0 / 83 |
Outcome results
Primary
Miscarriage Rate
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Metformin Arm | Miscarriage Rate | 9 participants |
| Control Arm | Miscarriage Rate | 35 participants |