Use of Low Dose of HCG During Ovulation Induction With CC in Women With CC Resistant PCOS

Sponsor

Mohamed Sayed Abdelhafez (Other)

Overall Status

Unknown status

CT.gov ID

NCT02436226

Collaborator

(none)

100

Enrollment

Locations

Arms

Duration (Months)

33.3

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Infertility Polycystic Ovarian Syndrome	Drug: Clomiphene citrate and Human chorionic gonadotropin (HCG) Drug: Clomiphene citrate	Phase 4

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

May 1, 2015

Anticipated Primary Completion Date :

Apr 1, 2020

Anticipated Study Completion Date :

May 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Clomiphene citrate-HCG group Women will receive clomiphene citrate and human chorionic gonadotropin (HCG)	Drug: Clomiphene 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) Other Names: Clomid and Choriomon
Active Comparator: Clomiphene citrate group Women will receive clomiphene citrate alone	Drug: Clomiphene citrate Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of cycle) Other Names: Clomid

Arm

Intervention/Treatment

Active Comparator: Clomiphene citrate-HCG group

Women will receive clomiphene citrate and human chorionic gonadotropin (HCG)

Drug: Clomiphene 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)

Other Names:

Clomid and Choriomon

Active Comparator: Clomiphene citrate group

Women will receive clomiphene citrate alone

Drug: Clomiphene citrate

Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of cycle)

Other Names:

Clomid

Outcome Measures

Primary Outcome Measures

Ovulation rate [3 months]
Number of ovulatory cycles divided by the number of stimulation cycles

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Obstetrics and Gynecology Department in Mansoura University Hospital	Mansourah	Egypt	35111
2	Private practice settings	Mansourah	Egypt	35111
3	Obstetrics and Gynecology Department in Port Said University	Port Said	Egypt