Clinical trial NCT02344888: Adding Prednisolone During Ovulation Induction With CC in Lean Women With CC Resistant PCOS
Official title: Adding Prednisolone During Ovulation Induction With Clomiphene Citrate in Lean Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infertility
Polycystic Ovarian Syndrome
Keywords: PCOS
Clomiphene citrate resistant
Prednisolone
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-01-26
Enrollment: 300
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of concomitant administration of prednisolone during use of clomiphene citrate (CC) for induction of ovulation in infertile lean women having CC resistant polycystic ovarian syndrome (PCOS).

Detailed description: Women will be randomly divided into two groups; CC-Prednisolone group and CC-placebo group. Women in the CC-Prednisolone group will receive CC (150 mg/day for 5 consecutive days from day 2 of the cycle) and prednisolone tablet (5 mg/day for 10 consecutive days from day 2 of the cycle). Women in the CC-placebo group will receive CC alone (150 mg/day for 5 consecutive days from day 2 of the cycle) and folic acid tablet (0.5 mg/day for 10 consecutive days from day 2 of the cycle). Transvaginal sonography (TVS) scan will be performed regularly for monitoring of follicular growth (folliculometry); starting from day 10 of the stimulation cycle and repeated every 2-3 days. When there will be at least one follicle ≥ 18 mm in diameter, final oocyte maturation will be induced by intramuscular administration of 10000 IU of human chorionic gonadotropin (HCG) and timed intercourse will be advised. If there will be no follicle ≥ 12 mm by day 16 of the cycle, monitoring of follicular growth will be discontinued and the cycle will be presumed to be anovulatory. Ovulation will be documented by TVS scan one week after triggering of oocyte maturation and will be confirmed by assessing the mid-luteal serum progesterone level. Each woman will be subjected to ovarian stimulation for a maximum of 3 consecutive cycles except if she gets pregnant in the first or second cycle

Eligibility criteria: Inclusion Criteria:

* Infertile lean women with PCOS as defined by the Rotterdam criteria.
* CC resistance (defined as failure of ovulation after receiving 150 mg/day of CC for 5 consecutive days per cycle, for at least 3 consecutive cycles).

Exclusion Criteria:

* Age \< 20 or \> 35 years.
* Body mass index (BMI) \< 18.5 kg/m2 or \> 25 kg/m2.
* Presence of any infertility factor other than anovulatory PCOS.
* Previous history of ovarian surgery or surgical removal of one ovary.
* Previous exposure to cytotoxic drugs or pelvic irradiation.
* Oral hypoglycemic or hormonal therapy either currently or in the preceding 3 months.
* Metabolic or hormonal abnormalities

Primary outcomes:
measure: Ovulation rate
timeFrame: 3 months
Secondary outcomes:
measure: Number of ovarian follicles ≥ 18 mm on day of HCG administration
timeFrame: 3 months
measure: Endometrial thickness on day of HCG administration
timeFrame: 3 months
measure: Clinical pregnancy rate
timeFrame: 6-8 weeks gestational age
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Obstetrics and Gynecology Department in Mansoura University Hospital
state: Dakahlia
city: Mansourah
country: Egypt
facility: Private practice settings
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Mahmoud M Abdelrazik, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University
name: Mahmoud Thabet, D
role: STUDY_DIRECTOR
References: