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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


N/A
18 Years
38 Years
Not Enrolling
Female
Polycystic Ovary Syndrome

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

ovulation rate

Outcome Description:

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

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Mohamad E Ghanem, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mansoura Integrated Fertility Center

Authority:

Egypt:Ministry of health

Study ID:

MansouraIFC1

NCT ID:

NCT01212263

Start Date:

January 2010

Completion Date:

September 2012

Related Keywords:

  • Polycystic Ovary Syndrome
  • PCOS
  • Clomiphene resistance
  • ovulation induction
  • low dose uFSH
  • uFSH step-up protocol
  • Polycystic Ovary Syndrome

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