Combined Pioglitazone and Clomophene Citrate Versus Combined Metformin and Clomiphene Citrate as First Treatment in Infertile Women With Polycystic Ovary Syndrome
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Clinical pregnancy rate
Study Overview
Brief Summary
Participants with PCOS will be divided into two groups then each group will randomly recieve one of the following treatment
- metformin will be adminstered in adose of 500 mg 3 times daily for 3 months to group B.
- pioglitazone will be administered in adose of 30 mg dialy for 3 months to group A.
- Induction of ovulation by clomiphene citate 50 mg tablets to all participants
Detailed Description
Participants with PCOS will be divided into two groups then each group will randomly recieve one of the following treatment
- metformin will be adminstered in adose of 500 mg 3 times daily for 3 months to group B.
- pioglitazone will be administered in adose of 30 mg dialy for 3 months to group A.
- Induction of ovulation by clomiphene citate 50 mg tablets once or twice dialy 12hours apart starting from the 3rd day of menstrual cycle and continue for five days during treatment with insulin sensitizing agents to group A and B.
Participants with oligomenorrhea will recieve two tablets of noreththisterone 5 mg tab every 12 hours for 5 days to allow for withdrawal bleeding before start ovulation induction
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 20 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •women age 20_35
- •BMI 18_29.9
- •Women with PCOS(diagnosed by using Rotterdam criteria
- •Infertility is cause for seeking tfeatment
Exclusion Criteria
- •Causes of infertility other than PCOS.
- •patient refusal.
- •Contraindication of any of the drugs used in the study
- •Cause of oligo/anovulation other than PCOS
- •Current or previous (within the last six month) use of oral contraceptives, glucocorticoids, antiandrogens, antidiabetics, antiobesity drugs or other hormonal drugs.
Arms & Interventions
Group A
Pioglitazone in adose 30 mg tablet will be administered dialy+ clomiphene citrate as ovulation induction
Intervention: Pioglitazone (Drug)
Group A
Pioglitazone in adose 30 mg tablet will be administered dialy+ clomiphene citrate as ovulation induction
Intervention: Clomiphene Citrate (Drug)
Group B
Metformin in adose 1500 mg dialy will be administered + clomiphene citrate
Intervention: Metformin (Drug)
Group B
Metformin in adose 1500 mg dialy will be administered + clomiphene citrate
Intervention: Clomiphene Citrate (Drug)
Outcomes
Primary Outcomes
Clinical pregnancy rate
Time Frame: 3 months
Pregnancy rate diagnosed by U/S at five weeks after missed menses
Secondary Outcomes
No secondary outcomes reported
Investigators
Asmaa Abdelbadea Ali Salih
Cairo
Ain Shams University