Adding Prednisolone During Ovulation Induction With CC in... | NCT02344888

Studies
Adding Prednisolone During Ovulation Induction With CC in Lean Women With CC Resistant PCOS

NCT02344888

Sponsor

Mahmoud Thabet

Status

Unknown status

Last Update Posted

Jan 8, 2019Actual

Enrollment

300Estimated

Phase

Phase 4

Conditions

Infertility
Polycystic Ovarian Syndrome

Interventions

Clomiphene citrate and Prednisolone
Clomiphene citrate and folic acid

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2015

Primary Completion Date

Jan 2019Actual

Completion Date

Jan 2019Estimated

First Submitted Date

Jan 18, 2015

First Submission Date that Met QC Criteria

Jan 22, 2015

First Posted Date

Jan 26, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 4, 2019

Last Update Posted Date

Jan 8, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the effect of concomitant administration of prednisolone during use of clomiphene citrate (CC) for induction of ovulation in infertile lean women having CC resistant polycystic ovarian syndrome (PCOS).

Detailed Description

Women will be randomly divided into two groups; CC-Prednisolone group and CC-placebo group. Women in the CC-Prednisolone group will receive CC (150 mg/day for 5 consecutive days from day 2 of the cycle) and prednisolone tablet (5 mg/day for 10 consecutive days from day 2 of the cycle). Women in the CC-placebo group will receive CC alone (150 mg/day for 5 consecutive days from day 2 of the cycle) and folic acid tablet (0.5 mg/day for 10 consecutive days from day 2 of the 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 human chorionic gonadotropin (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 mid-luteal 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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Clomiphene citrate-Prednisolone group	Active Comparator	Women will receive clomiphene citrate and prednisolone	Drug: Clomiphene citrate and Prednisolone
Clomiphene citrate-placebo group	Active Comparator	Women will receive clomiphene citrate and folic acid 0.5mg (placebo)	Drug: Clomiphene citrate and folic acid

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clomiphene citrate and Prednisolone	Drug	Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of the cycle) and prednisolone (5 mg/day for 10 consecutive days from day 2 of the cycle)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ovulation rate	Number of ovulatory cycles divided by the number of stimulation cycles	3 months

Secondary Outcomes

Measure	Description	Time Frame
Number of ovarian follicles ≥ 18 mm on day of HCG administration	Number of ovarian follicles ≥ 18 mm by TVS on day of HCG administration	3 months
Endometrial thickness on day of HCG administration

Other Outcomes

Not provided

Eligibility Module

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.
Body mass index (BMI) < 18.5 kg/m2 or > 25 kg/m2.
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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mahmoud M Abdelrazik, Dr	Contact	+201005548881		dr_mahmoudhosam@yahoo.com

Overall Officials

Name	Affiliation	Role
Mahmoud M Abdelrazik, Dr	Mansoura University	Principal Investigator
Mahmoud Thabet, D	Mansoura University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Obstetrics and Gynecology Department in Mansoura University Hospital	Recruiting	Al Mansurah	Dakahlia Governorate	35111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility
D011085	Polycystic Ovary Syndrome

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D010048	Ovarian Cysts
D003560	Cysts

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002996	Clomiphene
D011239	Prednisolone
D008775	Methylprednisolone
D005492	Folic Acid

Ancestor Terms

ID	Term
D013267	Stilbenes
D001597	Benzylidene Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided