Phase
Condition
Infertility
Treatment
N/AClinical Study ID
Ages 18-39 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 18-39 years of age.
BMI 18-29 Kg/m2
Polycystic ovary syndrome, diagnosed - according to the revised 2003 consensus ondiagnostic criteria of polycystic ovary syndrome by the Rotterdam ESHRE/ASRM-SponsoredPCOS Consensus Workshop Group - by the presence of two of the following threediagnostic features:
Oligo- or anovulation [defined as fewer than eight episodes of menstrual bleedingper year or menses that occur at intervals greater than 35 days].
Clinical hyperandrogenism [defined by the presence of hirsutism (assessed by amodified Ferriman-Gallwey score ≥ 8), acne or androgenic alopecia] and/orbiochemical signs of hyperandrogenism [defined by elevated free androgen index]
Polycystic ovaries [defined as presence of 12 or more follicles in each ovarymeasuring 2 - 9 mm in diameter, and/or increased ovarian volume > 10 mL) in theearly follicular phase (cycle days 3 - 5) in regularly menstruating women.Oligo-/amenorrhoeic women should be scanned either at random or between days 3and 5 after a progestin-induced withdrawal bleeding. This definition does notapply to women taking oral contraceptive pills, since their use modifies ovarianmorphology in normal women and putatively in women with PCO. After exclusion of other etiologies (congenital adrenal hyperplasia, androgensecreting tumors, Cushing's syndrome, hypothyroidism and hyperprolactinemia).
Normal transvaginal ultrasonography apart from polycystic ovaries (see before).
Normal office hysteroscopy.
Normal hysterosalpingography.
Absence of any structural pathological findings in laparoscopy apart from enlargedsclerotic polycystic ovaries.
Normal hormonal profile (apart from hormonal abnormalities associated with PCOS), e.g.normal thyroid function tests
Normal parameters of male semen analysis according to WHO criteria 2010.
First trial IVF/ICSI.
Written and signed informed consent by the patient to participate in the study.
Exclusion
Exclusion Criteria:
Age more than 39 years.
BMI more than 29 Kg/m2
Abnormal ultrasonographic finding, e.g. endometrial polyps, fibroids or ovarian cysts.
Abnormal hysteroscopic finding, e.g. endometrial polyps, endometrial hyperplasia orfibroid.
Abnormal hysterosalpingographic finding, e.g. hydrosalpinx or peritoneal adhesions.
Abnormal male or female karyotyping.
Abnormal endocrinological profile during ovarian stimulation not attributed to PCOS,e.g. hypothyroidism, FSH > 12 mIU/mL on day 3.
Previous trials of IVF/ICSI.
Positive anticardiolipin antibodies or lupus anticoagulant.
Positive thrombophilia screen.
Abnormal semen analysis parameters according to WHO criteria 2010.
Any hormonal treatment within the last 3 months.
Any treatment for insulin resistance within the last 3 months, e.g. metformin orleptin.
Any chronic medical disorder, e.g. hypertension, autoimmune disorders, … etc.
Any category 4 medical condition that contraindicates the usage of OCP according tothe WHO Medical eligibility criteria, 2015:
Smoking with age ≥ 35 years and cigarettes ≥ 15 /day.
Hypertension (systolic ≥ 160 mmHg or diastolic ≥ 90 mmHg).
Hypertension with vascular disease.
Previous history or acute DVT/PE.
Any known thrombogenic mutations.
Complicated valvular heart disease.
Systemic lupus erythematosus with positive or unkown antiphospholipid antibodies.
Migraine with aura.
Diabetes with nephropathy/neuropathy/retinopathy.
Diabetes > 20 years.
Acute hepatitis, severe cirrhosis or liver tumors.
- Mental condition rendering the patients unable to understand the nature, scope andpossible consequences of the study.
Study Design
Study Description
Connect with a study center
AinShams Maternity Hospital
Cairo, 002
EgyptActive - Recruiting
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