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Minimal Stimulation or Clomiphene Citrate in Treatment of Polycystic Ovary Syndrome

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
clomiphene citrate +highly purified uFSH
clomiphene citrate
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic ovary syndrome, clomiphene citrate, minimal stimulation, infertility treatment

Eligibility Criteria

20 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • PCOS
  • No other infertility factors
  • No previous use of ovarian stimulation drugs

Exclusion Criteria:

  • Congenital adrenal hyperplasia
  • Cushing syndrome
  • Androgen secreting tumors

Sites / Locations

  • Mansoura University Hospitals,OB/GYN department

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

minimal stimulation protocol

clomiphene citrate(CC)

Arm Description

5 days of CC (100mg/day) from day 3 followed by 150 IU of highly purified uFSH on cycle day 9 for three treatment cycles

5 days of CC (100mg/day) from cycle day 3 for three treatment cycles.

Outcomes

Primary Outcome Measures

clinical pregnancy rate per cycle

Secondary Outcome Measures

endometrial thickness at the time of hCG administration

Full Information

First Posted
July 6, 2010
Last Updated
July 16, 2010
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT01157312
Brief Title
Minimal Stimulation or Clomiphene Citrate in Treatment of Polycystic Ovary Syndrome
Official Title
Minimal Stimulation or Clomiphene Citrate as First Line Therapy in Women With Polycystic Ovary Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mansoura University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare and determine the the efficacy of minimal stimulation and clomiphene citrate(CC) as the first-line treatment in infertile women with Polycystic Ovary Syndrome(PCOS).
Detailed Description
All patients received 100 mg CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) for 5 days starting from day 3 of spontaneous or induced menstruation. In group A (minimal stimulation), 2 vials of highly purified uFSH , 150 IU (Fostimon; IBSA, Lugano, Switzerland, 75 IU/vial) were given IM on cycle day 9. A total of 3 cycles was offered to each group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Polycystic ovary syndrome, clomiphene citrate, minimal stimulation, infertility treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
minimal stimulation protocol
Arm Type
Experimental
Arm Description
5 days of CC (100mg/day) from day 3 followed by 150 IU of highly purified uFSH on cycle day 9 for three treatment cycles
Arm Title
clomiphene citrate(CC)
Arm Type
Active Comparator
Arm Description
5 days of CC (100mg/day) from cycle day 3 for three treatment cycles.
Intervention Type
Drug
Intervention Name(s)
clomiphene citrate +highly purified uFSH
Intervention Type
Drug
Intervention Name(s)
clomiphene citrate
Primary Outcome Measure Information:
Title
clinical pregnancy rate per cycle
Secondary Outcome Measure Information:
Title
endometrial thickness at the time of hCG administration

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: PCOS No other infertility factors No previous use of ovarian stimulation drugs Exclusion Criteria: Congenital adrenal hyperplasia Cushing syndrome Androgen secreting tumors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatem Abu Hashim, MD MRCOG
Organizational Affiliation
Mansoura University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed F Bazeed, MD
Organizational Affiliation
Mansoura University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ibrahim Abd Elaal, MD
Organizational Affiliation
Mansoura University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Mansoura University Hospitals,OB/GYN department
City
Mansoura
State/Province
Dakahlia Governorate
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
8774291
Citation
Lu PY, Chen AL, Atkinson EJ, Lee SH, Erickson LD, Ory SJ. Minimal stimulation achieves pregnancy rates comparable to human menopausal gonadotropins in the treatment of infertility. Fertil Steril. 1996 Mar;65(3):583-7. doi: 10.1016/s0015-0282(16)58158-8.
Results Reference
background
PubMed Identifier
11821101
Citation
Houmard BS, Juang MP, Soules MR, Fujimoto VY. Factors influencing pregnancy rates with a combined clomiphene citrate/gonadotropin protocol for non-assisted reproductive technology fertility treatment. Fertil Steril. 2002 Feb;77(2):384-6. doi: 10.1016/s0015-0282(01)02990-9.
Results Reference
background
PubMed Identifier
12512925
Citation
Dhaliwal LK, Sialy RK, Gopalan S, Majumdar S. Minimal stimulation protocol for use with intrauterine insemination in the treatment of infertility. J Obstet Gynaecol Res. 2002 Dec;28(6):295-9. doi: 10.1046/j.1341-8076.2002.00058.x.
Results Reference
background
PubMed Identifier
21770837
Citation
Abu Hashim H, Bazeed M, Abd Elaal I. Minimal stimulation or clomiphene citrate as first-line therapy in women with polycystic ovary syndrome: a randomized controlled trial. Gynecol Endocrinol. 2012 Feb;28(2):87-90. doi: 10.3109/09513590.2011.589924. Epub 2011 Jul 20.
Results Reference
derived

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Minimal Stimulation or Clomiphene Citrate in Treatment of Polycystic Ovary Syndrome

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