Letrozole Versus Clomiphene Citrate for Ovulation Induction in Women With Poly Cystic Ovary Syndrome ( PCOS )
LVCCFOROI
1 other identifier
interventional
110
0 countries
N/A
Brief Summary
110 infertile women diagnosed as polycystic ovary syndrome (PCOS) at the age group of 20-35 distributed randomly :
- 55 women will receive letrozole 2.5mg twice daily orally from the 2nd day to the 6thday of the cycle for three successive cycles.
- 55 women will receive clomiphene citrate 50 mg twice daily orally from the 2nd day to the 6thday of the cycle for three successive cycles. Patients will be subjected to: Complete history taking:
- Details about name, age
- Menstrual history with determination of menarche
- Amenorrhea or oligomenorrhea , Regularity of the cycle
- History of endocrine disease.
- History of previous operations.
- Physical examination:
- General examination: With special concern to:
- -Acne.
- -Hirsutism .
- -Weight.
- -Height
- -BMI was determined : Wt. in kg ـــــــــــــــــــ = ) Height in m)2 \- Abdominal examination :
- for scar of previous pelvic or abdominal operations .
- Pelvic examination :
- vaginal examination for enlarged cystic ovaries.
- ultrasound for diagnosis of pcos. PARAMETERS: (1) rate of ovulation (primary parameter). (2) serum progesterone level on day 21. (3) number of mature follicles produced per cycle. (4) mean endometrial thickness. (6) chemical pregnancy. (7) ongoing pregnancy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2015
Shorter than P25 for phase_2
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
September 5, 2015
CompletedFirst Posted
Study publicly available on registry
September 16, 2015
CompletedStudy Start
First participant enrolled
October 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedSeptember 16, 2015
September 1, 2015
7 months
September 5, 2015
September 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ovulation rate
Follicular monitoring will be done by transvaginal ultrasonography (TVS) on alternate days from day 9 of menstrual cycle until a mature follicle detected. Follicle considered mature when it attained 18 mm in size or more by averaging inner two diameters of the follicle. * A single injection of 10,000 IU hCGwill be given, if at least one follicle attained 18 mm. TVS will be done after 48 h of hCG injection to determine follicle rupture. If the follicle found unruptured, TVS repeated after 72 h of the hCG injection to detect whether follicle has ruptured or not. Ovulation ascertained by observing rupture of the follicle by ultrasonogram (USG). * Endometrial thickness of 8 mm considered a satisfactory response of the endometrium. * on day 21 serum progesterone level will measured. A progesterone level of 10 ng/ml considered as ovulatory. * Ovulation rate is assessed by number of mature follicle (diameter 18-22 mm) per cycle .
up to 24 weeks.
Secondary Outcomes (4)
day 21 progesterone level
up to 24 weeks
Endomertial thickness
up to 24 weeks
On gowing pregnancy
up to 24 weeks
Chemical pregnancy
up to 24 weeks
Study Arms (2)
letrozole
EXPERIMENTALpatients receive letrozole 2.5 mg twice daily from day 2 to day 6 of the cycle , for 3 consecutive cycles, hcg hormone10.000 iu im injection is given when mature follicle diameter reach 18 mm by trans vaginal ultrasound.
clomiphene citrate
ACTIVE COMPARATORpatients will receive clomiphene citrate 50 mg twice daily from day 2 to day 6 of the cycle for 3 consecutive cycles , hcg 10.000 hormone iu im injection is given when mature follicle diameter reach 18 mm by trans vaginal ultrasound .
Interventions
2.5 mg will taken from day 2 to day 6 of the cycle , for 3 consecutive cycles
50 mg twice daily orally from day 2 to day 6 , for 3 consecutive cycles
10.000 iu im injection when follicle diameter reach 18 mm by transvaginal ultrasound
Eligibility Criteria
You may qualify if:
- Age between 20-35
- Primary or secondary infertility
- Patients diagnosed as PCOs according to Rotterdam criteria (Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group.,2003)
You may not qualify if:
- Hyperprolactinemia.
- Male factor of infertility.
- WHO Guidelines 2010 for Normal seminal fluid analysis :
- Volume\> 1.5 ml
- ph 7.2 to 8.0
- Liquefaction time 20 to 30 min
- Sperms concentration \>15 million/ml
- Total motility 40%(Progressive motility + non progressive motility)
- Progressive motility 32%
- Morphology \> 4% normal forms
- Thyroid dysfunction.
- Diabetes Mellitus.
- Known or suspicious tubal factor infertility by HSG or laparoscope.
- Endometrioses or pelvic inflammatory diseases .
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- mostafa gomaa hamid halawalead
- Ain Shams Maternity Hospitalcollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
mohamed osama, md
ain-shams university , cairo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
September 5, 2015
First Posted
September 16, 2015
Study Start
October 1, 2015
Primary Completion
May 1, 2016
Study Completion
July 1, 2016
Last Updated
September 16, 2015
Record last verified: 2015-09