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

Information source: Mansoura University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infertility; Polycystic Ovarian Syndrome

Intervention: Clomiphene citrate and Human chorionic gonadotropin (HCG) (Drug); Clomiphene citrate (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Mohamed Sayed Abdelhafez

Official(s) and/or principal investigator(s):
Mahmoud Thabet, Dr, Principal Investigator, Affiliation: Mansoura University
Mohamed S Abdelhafez, Dr, Study Director, Affiliation: Mansoura University
Ahmed M Badawy, Prof, Study Chair, Affiliation: Mansoura University

Overall contact:
Mahmoud Thabet, Dr, Phone: +201003398201, Email: thabet0777@gmail.com

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).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Ovulation rate

Secondary outcome:

Number of ovarian follicles ≥ 18 mm on day of triggering of oocyte maturation

Endometrial thickness on day of triggering of oocyte maturation

Clinical pregnancy rate

Incidence of early ovarian hyperstimulation syndrome (OHSS)

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

Minimum age: 20 Years. Maximum age: 35 Years. Gender(s): Female.

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.

Locations and Contacts

Mahmoud Thabet, Dr, Phone: +201003398201, Email: thabet0777@gmail.com

Obstetrics and Gynecology Department in Mansoura University Hospital, Mansoura, Dakahlia 35111, Egypt; Recruiting
Mahmoud Thabet, Dr, Phone: +201003398201, Email: thabet0777@gmail.com

Private practice settings, Mansoura, Dakahlia, Egypt; Recruiting

Additional Information

Starting date: May 2015
Last updated: July 20, 2015

Page last updated: August 23, 2015

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