Use of Low Dose of HCG During Ovulation Induction With CC in Women With CC Resistant PCOS
Primary Purpose
Infertility, Polycystic Ovarian Syndrome
Status
Unknown status
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Clomiphene citrate and Human chorionic gonadotropin (HCG)
Clomiphene citrate
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring PCOS, Clomiphene citrate resistant, HCG
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.
Sites / Locations
- Obstetrics and Gynecology Department in Mansoura University HospitalRecruiting
- Private practice settingsRecruiting
- Obstetrics and Gynecology Department in Port Said UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Clomiphene citrate-HCG group
Clomiphene citrate group
Arm Description
Women will receive clomiphene citrate and human chorionic gonadotropin (HCG)
Women will receive clomiphene citrate alone
Outcomes
Primary Outcome Measures
Ovulation rate
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
Number of ovarian follicles ≥ 18 mm by TVS on day of triggering of oocyte maturation
Endometrial thickness on day of triggering of oocyte maturation
Endometrial thickness by Transvaginal sonography (TVS) scan on day of triggering of oocyte maturation
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
Incidence of early ovarian hyperstimulation syndrome (OHSS)
Incidence of OHSS within 9 days of final triggering of oocyte maturation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02436226
Brief Title
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
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohamed Sayed Abdelhafez
4. Oversight
Data Monitoring Committee
No
5. 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).
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Polycystic Ovarian Syndrome
Keywords
PCOS, Clomiphene citrate resistant, HCG
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Clomiphene citrate-HCG group
Arm Type
Active Comparator
Arm Description
Women will receive clomiphene citrate and human chorionic gonadotropin (HCG)
Arm Title
Clomiphene citrate group
Arm Type
Active Comparator
Arm Description
Women will receive clomiphene citrate alone
Intervention Type
Drug
Intervention Name(s)
Clomiphene citrate and Human chorionic gonadotropin (HCG)
Other Intervention Name(s)
Clomid and Choriomon
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Clomiphene citrate
Other Intervention Name(s)
Clomid
Intervention Description
Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of cycle)
Primary Outcome Measure Information:
Title
Ovulation rate
Description
Number of ovulatory cycles divided by the number of stimulation cycles
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of ovarian follicles ≥ 18 mm on day of triggering of oocyte maturation
Description
Number of ovarian follicles ≥ 18 mm by TVS on day of triggering of oocyte maturation
Time Frame
3 months
Title
Endometrial thickness on day of triggering of oocyte maturation
Description
Endometrial thickness by Transvaginal sonography (TVS) scan on day of triggering of oocyte maturation
Time Frame
3 months
Title
Clinical pregnancy rate
Description
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
Time Frame
6-8 weeks gestational age
Title
Incidence of early ovarian hyperstimulation syndrome (OHSS)
Description
Incidence of OHSS within 9 days of final triggering of oocyte maturation
Time Frame
Within 9 days of final triggering of oocyte maturation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Thabet, Dr
Phone
+201003398201
Email
thabet0777@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Thabet, Dr
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed S Abdelhafez, Dr
Organizational Affiliation
Mansoura University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mahmoud M Abdelrazik, MD
Organizational Affiliation
Mansoura University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Waleed El-refaie, MD
Organizational Affiliation
Port Said University
Official's Role
Study Director
Facility Information:
Facility Name
Obstetrics and Gynecology Department in Mansoura University Hospital
City
Mansourah
ZIP/Postal Code
35111
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud Thabet, Dr
Phone
+201003398201
Email
thabet0777@gmail.com
Facility Name
Private practice settings
City
Mansourah
ZIP/Postal Code
35111
Country
Egypt
Individual Site Status
Recruiting
Facility Name
Obstetrics and Gynecology Department in Port Said University
City
Port Said
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Waleed El-refaie, Dr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Use of Low Dose of HCG During Ovulation Induction With CC in Women With CC Resistant PCOS
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