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

NCT01212263 | Completed

• 1 other identifier: MansouraIFC1
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Polycystic Ovary Syndrome

Keywords

PCOS; Clomiphene resistance; ovulation induction; low dose uFSH; uFSH step-up protocol

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Live birth rate

  6 months

• number of follicles sized 16 mm or more mean diameter in both ovaries at the time of hCG

  3 months

• Endometrial thickness

  3 months

• serum Estradiol(E2)

  3 months

• incidence of multiple pregnancy

  3 months

Study Arms (2)

Clomiphene Citrate plus HP uFSH

EXPERIMENTAL

Starting from the 2nd day of the cycle Clomiphene Citrate( CC)50 mg tablets are given in 100 mg daily dose for 5 days together with an low dose HP uFSH (half ampoule: 37.5 IU) given im daily for 8-10 days.

Drug: Clomiphine citrate plus low dose uFSH

Step-up HP uFSH

ACTIVE COMPARATOR

HP uFSH started in doses of half ampole (37.5 )IU daily from the 2nd day of cycle for 7 days ,then dose is stepped-up to one ampoule ( 75 IU) for 7 days then the one and a half amps (112.5) IU /day until follicular diameter reaches 18 mm mean diameter

Drug: Step-up HP u FSH

Interventions

Step-up HP u FSH DRUG

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

Step-up HP uFSH

Clomiphine citrate plus low dose uFSH DRUG

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

Clomiphene Citrate plus HP uFSH

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura Integrated Fertility Center: lead

Study Sites (1)

Mansoura Integrated fertility Center

Al Mansurah, Dekahlia, Egypt

Location

Related Publications (3)

• 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.

  PMID: 19809318 BACKGROUND

• 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.

  PMID: 17185789 BACKGROUND

• 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.

  PMID: 24014214 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Mohamad E Ghanem, MD

  Mansoura Integrated Fertility Center

  STUDY CHAIR

• Mohammad A Emam, MD

  Mansoura Integrated Fertility Center

  STUDY DIRECTOR

• Mohamad E Ghanem, MD

  Mansoura Integrated Fertility Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: September 30, 2010
• Study Start: January 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: May 30, 2013

Record last verified: 2013-05

Locations

EG (1)