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

Infertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02436226
• Other study ID #: MT1
• Status: Completed
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: January 2023

Study information

• Verified date: October 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: January 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Polycystic Ovarian Syndrome
• Polycystic Ovary Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Egypt	Obstetrics and Gynecology Department in Mansoura University Hospital	Mansourah

Sponsors (1)

Lead Sponsor	Collaborator
Mohamed Sayed Abdelhafez

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ovulation rate	Number of ovulatory cycles divided by the number of stimulation cycles	3 months
Secondary	Number of ovarian follicles = 18 mm on day of triggering of oocyte maturation	Number of ovarian follicles = 18 mm by TVS on day of triggering of oocyte maturation	3 months
Secondary	Endometrial thickness on day of triggering of oocyte maturation	Endometrial thickness by Transvaginal sonography (TVS) scan on day of triggering of oocyte maturation	3 months
Secondary	Clinical pregnancy rate	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	6-8 weeks gestational age
Secondary	Incidence of early ovarian hyperstimulation syndrome (OHSS)	Incidence of OHSS within 9 days of final triggering of oocyte maturation	Within 9 days of final triggering of oocyte maturation