Clinical trial NCT01212263: Clomiphene Citrate (CC) Co-treatment With HP Urinary FSH vs HP Urinary FSH in CC-resistant PCOS
Official title: Clomiphene Citrate Co-treatment With Low Dose HP Urinary FSH vs. HP Urinary FSH Step-up Protocol for Clomiphene-citrate Resistant PCOS Anovulatory Infertility: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
Clomiphene resistance
ovulation induction
low dose uFSH
uFSH step-up protocol
Lead sponsor: Mansoura Integrated Fertility Center
Sponsor class: OTHER
First posted: 2010-09-30
Enrollment: 174
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To test whether adding small doses of HP urinary FSH to standard regimen of clomiphene citrate in clomiphene resistant PCOS well yield better results in terms of better ovulation rate,lower follicle number, less consumption of HP urinary FSH,lower treatment cost , better pregnancy rate, lower multiple pregnancy rates compared with the exclusive use of HP urinary FSH in these cases.

Detailed description: To test whether CC co- treatment with chronic low dose HP uFSH vs chronic low dose HP uFSH in CC resistant PCOS will yield better results in terms of ,ovulation rate, lower follicle number,lower HP uFSH dose ,better outcome in terms of pregnancy rates, better cost-effectiveness ratio, lower multiple pregnancy rates,lower cycle cancellation.

Eligibility criteria: Inclusion Criteria:

* CC resistant PCOS
* Infertile
* Females
* Age 18-38

Exclusion Criteria:

* Hyperprolactinaemia
* Cushing syndrome
* Adult onset adrenal hyperplasia
* Age \>38
* Other infertility factors in the couple than PCOS: male factor,tubal factor,edometriosis

Primary outcomes:
measure: ovulation rate
timeFrame: 6 months
Secondary outcomes:
measure: Live birth rate
timeFrame: 6 months
measure: number of follicles sized 16 mm or more mean diameter in both ovaries at the time of hCG
timeFrame: 3 months
measure: Endometrial thickness
timeFrame: 3 months
measure: serum Estradiol(E2)
timeFrame: 3 months
measure: incidence of multiple pregnancy
timeFrame: 3 months
measure: costs per cycle
timeFrame: 3 months
measure: cost effectiveness ratio
timeFrame: 6 months
measure: clinical and biochemical predictors of response to treatment
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura Integrated fertility Center
state: Dekahlia
Study officials:
affiliation: Mansoura Integrated Fertility Center
name: Mohamad E Ghanem, MD
role: STUDY_CHAIR
affiliation: Mansoura Integrated Fertility Center
name: Mohammad A Emam, MD
role: STUDY_DIRECTOR
affiliation: Mansoura Integrated Fertility Center
name: Mohamad E Ghanem, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Palomba S, Falbo A, Zullo F. Management strategies for ovulation induction in women with polycystic ovary syndrome and known clomifene citrate resistance. Curr Opin Obstet Gynecol. 2009 Dec;21(6):465-73. doi: 10.1097/GCO.0b013e328332d188.
citation: Gorry A, White DM, Franks S. Infertility in polycystic ovary syndrome: focus on low-dose gonadotropin treatment. Endocrine. 2006 Aug;30(1):27-33. doi: 10.1385/ENDO:30:1:27.
citation: Ghanem ME, Elboghdady LA, Hassan M, Helal AS, Gibreel A, Houssen M, Shaker ME, Bahlol I, Mesbah Y. Clomiphene citrate co-treatment with low dose urinary FSH versus urinary FSH for clomiphene resistant PCOS: randomized controlled trial. J Assist Reprod Genet. 2013 Nov;30(11):1477-85. doi: 10.1007/s10815-013-0090-2. Epub 2013 Sep 7.