Minimal Stimulation or Clomiphene Citrate in Treatment of Polycystic Ovary Syndrome
2 other identifiers
interventional
113
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 6, 2010
CompletedFirst Posted
Study publicly available on registry
July 7, 2010
CompletedJuly 19, 2010
July 1, 2010
1.7 years
July 6, 2010
July 16, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
clinical pregnancy rate per cycle
Secondary Outcomes (1)
endometrial thickness at the time of hCG administration
Study Arms (2)
minimal stimulation protocol
EXPERIMENTAL5 days of CC (100mg/day) from day 3 followed by 150 IU of highly purified uFSH on cycle day 9 for three treatment cycles
clomiphene citrate(CC)
ACTIVE COMPARATOR5 days of CC (100mg/day) from cycle day 3 for three treatment cycles.
Interventions
Eligibility Criteria
You may qualify if:
- PCOS
- No other infertility factors
- No previous use of ovarian stimulation drugs
You may not qualify if:
- Congenital adrenal hyperplasia
- Cushing syndrome
- Androgen secreting tumors
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mansoura University Hospitals,OB/GYN department
Al Mansurah, Dakahlia Governorate, Egypt
Related Publications (4)
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.
PMID: 8774291BACKGROUNDHoumard 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.
PMID: 11821101BACKGROUNDDhaliwal 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.
PMID: 12512925BACKGROUNDAbu 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.
PMID: 21770837DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hatem Abu Hashim, MD MRCOG
Mansoura University Hospital
- STUDY DIRECTOR
Mohamed F Bazeed, MD
Mansoura University Hospital
- STUDY CHAIR
Ibrahim Abd Elaal, MD
Mansoura University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 6, 2010
First Posted
July 7, 2010
Study Start
August 1, 2008
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
July 19, 2010
Record last verified: 2010-07