Clinical trial NCT01157312: 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
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic ovary syndrome
clomiphene citrate
minimal stimulation
infertility treatment
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2010-07-07
Enrollment: 113
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: clinical pregnancy rate per cycle
Secondary outcomes:
measure: endometrial thickness at the time of hCG administration
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospitals,OB/GYN department
state: Dakahlia Governorate
Study officials:
affiliation: Mansoura University Hospital
name: Hatem Abu Hashim, MD MRCOG
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University Hospital
name: Mohamed F Bazeed, MD
role: STUDY_DIRECTOR
affiliation: Mansoura University Hospital
name: Ibrahim Abd Elaal, MD
role: STUDY_CHAIR
References:
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.
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.
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.
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.