Ovulation Induction in Women With Clomiphene Citrate Resistant PCOS
Combined Letrozole-metformin-pioglitazone Versus Combined Clomiphene Citrate-metformin-pioglitazone in Clomiphene Citrate-resistant Women With Polycystic Ovary Syndrome
1 other identifier
interventional
100
1 country
1
Brief Summary
Polycystic ovary syndrome (PCOS) affects 5-10% of women in childbearing age. Hyperinsulinemia contributes to chronic anovulation commonly encountered in women with PCOS. The first choice therapy is clomiphene citrate (CC). In CC resistant cases, the American College of Obstetrics and Gynecology (ACOG) recommends the use of insulin sensitizer metformin. Other insulin sensitizing agents include rosiglitazone and pioglitazone. Pioglitazone is said to improve fertility and ovulation in patients with PCOS.CC may be associated with poor endometrial thickening due to its antiestrogenic effect. Letrozole may improve this condition. In this study we will compare the effect of combined letrozole-metformin-pioglitazone with that of combined CC-metformin-pioglitazone in ovulation induction in CC-resistant PCOS women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Aug 2013
Shorter than P25 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2013
CompletedFirst Posted
Study publicly available on registry
July 26, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
March 2, 2015
CompletedOctober 20, 2015
September 1, 2015
6 months
July 15, 2013
February 3, 2015
September 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ovulation Rate
3 months
Secondary Outcomes (3)
Number of Follicles>18mm.
3 months
Endometrial Thickness
3 months
Pregnancy Rate
3 months
Other Outcomes (1)
Safety of Pioglitazone as Regards Serum Creatinine
3 months
Study Arms (2)
arm 1:letrozole-pioglitazone -metformin group
ACTIVE COMPARATORArm 1 will receive letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.
arm 2: clomiphene citrate-pioglitazone-metformin
ACTIVE COMPARATORArm 2 will receive clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.
Interventions
induction of ovulation will be done for arm 1 for 3 consecutive cycles unless pregnancy occured.
induction of ovulation for arm 2 will be done in 3 consecutive cycles unless pregnancy occured.
transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of \> 18 mm or till day 20 of the cycle
BMI will be calculated for all women by dividing the weight in kilograms by the height in meters squared
baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) will be done for all women.
blood urea and serum creatinine will be assayed before stating induction of ovulation to have baseline levels.
serum E2 will be assayed on day 12 of the cycle for all women.
serum progesterone will be assayed on day 21 for all women to monitor ovulation.
blood urea and serum creatinine will be assayed every month during the treatment period to find out any hazards on kidney functions
Eligibility Criteria
You may qualify if:
- years old
- PCOS infertile women resistant to CC for3 cycles
You may not qualify if:
- presence of medical disorders as diabetes, hypertension, cardiac problems, liver or kidney diseases, hyperprolactinemia or thyroid dysfunction.
- use of gonadotropins before
- previous ovarian drilling
- presence of urinary symptoms especially bloody urine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Cairo University
Cairo, Egypt
Related Publications (1)
El-khayat W, Abdel Moety G, Al Mohammady M, Hamed D. A randomized controlled trial of clomifene citrate, metformin, and pioglitazone versus letrozole, metformin, and pioglitazone for clomifene-citrate-resistant polycystic ovary syndrome. Int J Gynaecol Obstet. 2016 Feb;132(2):206-9. doi: 10.1016/j.ijgo.2015.06.063. Epub 2015 Nov 6.
PMID: 26613820DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Ghada Abdel Fattah
- Organization
- Cairo University
Study Officials
- PRINCIPAL INVESTIGATOR
Ghada Abdel Fattah Abdel Moety, lecturer
Cairo University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer of Obstetrics and Gynecology-Cairo University
Study Record Dates
First Submitted
July 15, 2013
First Posted
July 26, 2013
Study Start
August 1, 2013
Primary Completion
February 1, 2014
Study Completion
April 1, 2014
Last Updated
October 20, 2015
Results First Posted
March 2, 2015
Record last verified: 2015-09