Clinical trial NCT02436226: Use of Low Dose of HCG During Ovulation Induction With CC in Women With CC Resistant PCOS
Official title: Use of Low Dose of Human Chorionic Gonadotropin During Ovulation Induction With Clomiphene Citrate in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Polycystic Ovarian Syndrome
Keywords: PCOS
Clomiphene citrate resistant
HCG
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-05-06
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 administration of low dose of human chorionic gonadotropin (HCG) after use of clomiphene citrate (CC) for induction of ovulation in infertile women having CC resistant polycystic ovarian syndrome (PCOS).

Detailed description: Women will be randomly divided into two groups; CC-HCG group and CC group. Women in the CC-HCG group will receive CC (150 mg/day for 5 consecutive days from day 2 of cycle) and HCG (200 IU/day SC from day 7 of cycle). Women in the CC group will receive CC alone (150 mg/day for 5 consecutive days from day 2 of 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 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 midluteal 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.
* 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 triggering of oocyte maturation
timeFrame: 3 months
measure: Endometrial thickness on day of triggering of oocyte maturation
timeFrame: 3 months
measure: Clinical pregnancy rate
timeFrame: 6-8 weeks gestational age
measure: Incidence of early ovarian hyperstimulation syndrome (OHSS)
timeFrame: Within 9 days of final triggering of oocyte maturation
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Obstetrics and Gynecology Department in Mansoura University Hospital
Study officials:
affiliation: Mansoura University
name: Mahmoud Thabet, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University
name: Khaled S Ismael, MD
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Ahmed Ragab, MD
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Maged R Elshamy, MD
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Mohamed A Elnegery, MD
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Hamed Youssef, MD
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Mahmoud M Abdel-razik, MD
role: STUDY_DIRECTOR
affiliation: Mansoura University
name: Mohamed S Abdelhafez, MD
role: STUDY_CHAIR
References: