Back to resultsIVF Versus Gonadotropin Therapy in Women With CC Resistant PCOS
Primary Purpose
Infertility, Polycystic Ovarian Syndrome
Status
Withdrawn
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
IVF
Gonadotropin
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring PCOS, Clomiphene citrate resistant, Gonadotropin, IVF
Eligibility Criteria
Inclusion Criteria:
- Infertile 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
- Fertility Care Unit (FCU) in Mansoura University Hospital
- Private fertility care centers
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
IVF group
Gonadotropin group
Arm Description
Women will undergo one full IVF cycle
Women will be subjected to ovarian stimulation for 6 months with the gonadotropin low-dose step-down protocol.
Outcomes
Primary Outcome Measures
Live birth rate
Number of live births divided by the number of women
Secondary Outcome Measures
Clinical pregnancy rate
Number of clinical pregnancies divided by the number of women
Multifetal pregnancy rate
Number of multifetal pregnancies divided by the number of clinical pregnancies
Miscarriage rate
Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies
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
NCT02458963
Brief Title
IVF Versus Gonadotropin Therapy in Women With CC Resistant PCOS
Official Title
In Vitro Fertilization Versus Gonadotropin Therapy in Women With Clomiphene Citrate Resistant Polycystic Ovarian Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Withdrawn
Study Start Date
January 2016 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
May 2017 (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 compare the efficacy of in vitro fertilization (IVF) versus gonadotropin therapy in infertile women having clomiphene citrate (CC) resistant polycystic ovarian syndrome (PCOS).
Detailed Description
Women will be randomly divided into two groups; IVF group and gonadotropin group. Women in the IVF group will undergo one full IVF cycle. Women in the gonadotropin group will be subjected to ovarian stimulation for 6 months with the gonadotropin low-dose step-down protocol.
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, Gonadotropin, IVF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IVF group
Arm Type
Active Comparator
Arm Description
Women will undergo one full IVF cycle
Arm Title
Gonadotropin group
Arm Type
Active Comparator
Arm Description
Women will be subjected to ovarian stimulation for 6 months with the gonadotropin low-dose step-down protocol.
Intervention Type
Procedure
Intervention Name(s)
IVF
Other Intervention Name(s)
Intracytoplasmic sperm injection (ICSI)
Intervention Description
Women will undergo one IVF cycle
Intervention Type
Drug
Intervention Name(s)
Gonadotropin
Other Intervention Name(s)
Human Menopausal Gonadotropin (HMG)
Intervention Description
Women will be subjected to ovarian stimulation for 6 months with the gonadotropin low-dose step-down protocol
Primary Outcome Measure Information:
Title
Live birth rate
Description
Number of live births divided by the number of women
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
Number of clinical pregnancies divided by the number of women
Time Frame
6-8 weeks gestational age
Title
Multifetal pregnancy rate
Description
Number of multifetal pregnancies divided by the number of clinical pregnancies
Time Frame
12 weeks gestational age
Title
Miscarriage rate
Description
Number of first trimester miscarriages (before 12 weeks gestational age) divided by the number of clinical pregnancies
Time Frame
12 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Gibreel, 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
Facility Information:
Facility Name
Fertility Care Unit (FCU) in Mansoura University Hospital
City
Mansoura
State/Province
Dakahlia
ZIP/Postal Code
35111
Country
Egypt
Facility Name
Private fertility care centers
City
Mansoura
State/Province
Dakahlia
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
IVF Versus Gonadotropin Therapy in Women With CC Resistant PCOS
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