Polycystic Ovary Syndrome Clinical Trial
— LVCCFOROIOfficial title:
Letrozole Versus Clomiphene Citrate for Ovulation Induction in Women With Polycystic Ovary Syndrome
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:
1. Details about name, age
2. Menstrual history with determination of menarche
3. Amenorrhea or oligomenorrhea , Regularity of the cycle
4. History of endocrine disease.
5. 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
Status | Not yet recruiting |
Enrollment | 110 |
Est. completion date | July 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 35 Years |
Eligibility |
Inclusion Criteria: 1. Age between 20-35 2. Primary or secondary infertility 3. Patients diagnosed as PCOs according to Rotterdam criteria (Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group.,2003) Exclusion Criteria: Any patients have any causes of infertility other than which mentioned in the inclusion criteria as: 1. Hyperprolactinemia. 2. 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 3. Thyroid dysfunction. 4. Diabetes Mellitus. 5. Known or suspicious tubal factor infertility by HSG or laparoscope. 6. Endometrioses or pelvic inflammatory diseases . |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
mostafa gomaa hamid halawa | Ain Shams Maternity Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Yes |
Secondary | day 21 progesterone level | day 21 serum progesterone level 10 ng/ml is ovulatory | up to 24 weeks | Yes |
Secondary | Endomertial thickness | Endometrial thickness of 8 mm considered a satisfactory response of the endometrium. | up to 24 weeks | Yes |
Secondary | On gowing pregnancy | pregnancy when diagnosed by ultrasound . | up to 24 weeks | Yes |
Secondary | Chemical pregnancy | pregnancy when diagnosed by serum positive hcg test . | up to 24 weeks | Yes |
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