Clomiphene Citrate (CC) Co-treatment With HP Urinary FSH vs HP Urinary FSH in CC-resistant PCOS

Polycystic Ovary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01212263
• Other study ID #: MansouraIFC1
• Status: Completed
• Phase: N/A
• First received: September 29, 2010
• Last updated: May 29, 2013
• Start date: January 2010
• Est. completion date: September 2012

Study information

• Verified date: May 2013
• Source: Mansoura Integrated Fertility Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt:Ministry of health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

Drug:
• Step-up HP u FSH
HP u FSH (Fostimone 75 IU ,IBSA Institut Biochimique SA-CH 6903 Lugano) in doses of 37.5 IU (half ampole) im /day statrted from second day of the cycle for 7 days ,then increased to 75 IU for another 7 days ,then to 112.5 IU (one and half ampoule) untilleading follicle mean diameter reaches 18 mm
• Clomiphine citrate plus low dose uFSH
Clomiphene citrate 50 mg tab oral tablets(Clomid 50 mg tablets Global Napi , Egypt) two tablets(100 mg) /day are started from the 2nd day of cycle for 5 days togeteher with 37.5 IU HP uFSH (Fostimone 75 IU IBSA)/day for 8 days and may be extended to 10-12 days until leading follicle diameter reaches 18 mm

Locations

Country	Name	City	State
Egypt	Mansoura Integrated fertility Center	Mansoura	Dekahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura Integrated Fertility Center

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Gorry A, White DM, Franks S. Infertility in polycystic ovary syndrome: focus on low-dose gonadotropin treatment. Endocrine. 2006 Aug;30(1):27-33. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ovulation rate	IF CC Co-treatment with low dose step-up HP urinary(u)FSH results in similar or higher ovulation rate compared with step-up low dose HP uFSH	6 months	No
Secondary	Live birth rate	% of of cases that result in live birth > 20 weeks pregnancy	6 months	No
Secondary	number of follicles sized 16 mm or more mean diameter in both ovaries at the time of hCG	To test if CC-co treatment with low dose HP uFSH results in lower number of follicles 16 mm mean diameter or more at time of triggerring ovulation compared with low dose HP uFSH	3 months	Yes
Secondary	Endometrial thickness	Measuring endometrial thickness in mm in both study arms at the time of ovulation trigerring to see if there is difference	3 months	No
Secondary	serum Estradiol(E2)	serum level of E2 is measured in both groups at the time of ovulation triggerring to test for differences	3 months	No
Secondary	incidence of multiple pregnancy	To test if CC-co treatment with low dose HP uFSH results in lower or higher incidence of multiple pregnancies compared with low dose HP uFSH	3 months	Yes
Secondary	costs per cycle	costs of drugs used to induce ovulation in each arm of the study in Egyptian pounds The cost of HP uFSH per cycle was calculated by multiplying the cost of a single IU with the mean number of FSH IU used per cycle. Add to this the cost of clomiphene citrate in the relevant arm	3 months	No
Secondary	cost effectiveness ratio	The cost-effectiveness ratio is calculated multiplying the cost per cycle by the total number of cycles performed in each arm then dividing the result for the number of clinical pregnancies obtained in the arm during the trial.	6 months	No
Secondary	clinical and biochemical predictors of response to treatment		6 weeks	No