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CompletedNCT01157312Updated Jul 19, 2010

Minimal Stimulation or Clomiphene Citrate in Treatment of Polycystic Ovary Syndrome

An interventional study of clomiphene citrate +highly purified uFSH and clomiphene citrate in Polycystic Ovary Syndrome, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 39 Years. Per ClinicalTrials.gov, last updated 2010-07-19.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
113
Allocation
Randomized
Ages
20 Years to 39 Years
Sex
Female
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Study 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).

Read the 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.

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Conditions studied

  • Polycystic Ovary Syndrome

Keywords

  • Polycystic ovary syndrome
  • clomiphene citrate
  • minimal stimulation
  • infertility treatment
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In context

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.

This study's enrollment of 113 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Congenital adrenal hyperplasia
  • Cushing syndrome
  • Androgen secreting tumors
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
113 participants (actual)

Study arms

  • Experimental
    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

    Drug: clomiphene citrate +highly purified uFSH

  • Active comparator
    clomiphene citrate(CC)

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

    Drug: clomiphene citrate

Interventions

  • Drugclomiphene citrate +highly purified uFSH
  • Drugclomiphene citrate
06

What researchers measure

Primary outcomes

  1. clinical pregnancy rate per cycle

Secondary outcomes

  1. endometrial thickness at the time of hCG administration

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Study locations

1 site
  • Mansoura University Hospitals,OB/GYN department
    Mansoura, Dakahlia Governorate, Egypt
08

References and documents

Publications

  • 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. PubMed 8774291 ↗
  • 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. PubMed 11821101 ↗
  • 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. PubMed 12512925 ↗
  • 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. PubMed 21770837 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01157312
Lead sponsor
Mansoura University
First posted
Jul 7, 2010
Start date
Aug 2008
Primary completion
Apr 2010
Completion
Apr 2010
Last update
Jul 19, 2010

Study contacts

Hatem Abu Hashim, MD MRCOG
principal investigator · Mansoura University Hospital
Mohamed F Bazeed, MD
study director · Mansoura University Hospital
Ibrahim Abd Elaal, MD
study chair · Mansoura University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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