Infertility, Polycystic Ovarian Syndrome
Conditions
Keywords
PCOS, Clomiphene citrate resistant, HCG
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
Interventions
DRUGClomiphene citrate and Human chorionic gonadotropin (HCG)
Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of cycle) and HCG (200 IU/day SC from day 7 of cycle)
DRUGClomiphene citrate
Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of cycle)
Sponsors
Mohamed Sayed Abdelhafez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ovulation rate | 3 months | Number of ovulatory cycles divided by the number of stimulation cycles |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of ovarian follicles ≥ 18 mm on day of triggering of oocyte maturation | 3 months | Number of ovarian follicles ≥ 18 mm by TVS on day of triggering of oocyte maturation |
| Endometrial thickness on day of triggering of oocyte maturation | 3 months | Endometrial thickness by Transvaginal sonography (TVS) scan on day of triggering of oocyte maturation |
| Clinical pregnancy rate | 6-8 weeks gestational age | Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 6-8 weeks gestational age) divided by the number of women |
| Incidence of early ovarian hyperstimulation syndrome (OHSS) | Within 9 days of final triggering of oocyte maturation | Incidence of OHSS within 9 days of final triggering of oocyte maturation |
Countries
Egypt
Outcome results
None listed