Minimal Stimulation or Clomiphene Citrate in Treatment of Polycystic Ovary Syndrome

NCT ID: NCT01157312

Last Updated: 2010-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-04-30

Brief Summary

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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

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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.

Conditions

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Polycystic Ovary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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minimal stimulation protocol

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

Group Type EXPERIMENTAL

clomiphene citrate +highly purified uFSH

Intervention Type DRUG

clomiphene citrate(CC)

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

Group Type ACTIVE_COMPARATOR

clomiphene citrate

Intervention Type DRUG

Interventions

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clomiphene citrate +highly purified uFSH

Intervention Type DRUG

clomiphene citrate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Congenital adrenal hyperplasia
* Cushing syndrome
* Androgen secreting tumors
Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Mansoura Faculty of Medicine, Mansoura University.

Principal Investigators

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Hatem Abu Hashim, MD MRCOG

Role: PRINCIPAL_INVESTIGATOR

Mansoura University Hospital

Mohamed F Bazeed, MD

Role: STUDY_DIRECTOR

Mansoura University Hospital

Ibrahim Abd Elaal, MD

Role: STUDY_CHAIR

Mansoura University Hospital

Locations

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Mansoura University Hospitals,OB/GYN department

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 8774291 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11821101 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12512925 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21770837 (View on PubMed)

Other Identifiers

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FMH-212-G

Identifier Type: -

Identifier Source: secondary_id

MU-290s

Identifier Type: -

Identifier Source: org_study_id

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