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

Primary Purpose

Polycystic Ovary Syndrome

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Step-up HP u FSH

Clomiphine citrate plus low dose uFSH

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring PCOS, Clomiphene resistance, ovulation induction, low dose uFSH, uFSH step-up protocol

Eligibility Criteria

18 Years - 38 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Mansoura Integrated fertility Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Clomiphene Citrate plus HP uFSH

Step-up HP uFSH

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Live birth rate

% of of cases that result in live birth > 20 weeks pregnancy

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

Endometrial thickness

Measuring endometrial thickness in mm in both study arms at the time of ovulation trigerring to see if there is difference

serum Estradiol(E2)

serum level of E2 is measured in both groups at the time of ovulation triggerring to test for differences

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

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

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.

clinical and biochemical predictors of response to treatment

Full Information

NCT ID

NCT01212263

First Posted

September 29, 2010

Last Updated

May 29, 2013

Sponsor

Mansoura Integrated Fertility Center

1. Study Identification

Unique Protocol Identification Number

NCT01212263

Brief Title

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

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mansoura Integrated Fertility Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polycystic Ovary Syndrome

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

174 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Clomiphene Citrate plus HP uFSH

Arm Type

Experimental

Arm Description

Arm Title

Step-up HP uFSH

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Step-up HP u FSH

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Clomiphine citrate plus low dose uFSH

Intervention Description

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

Primary Outcome Measure Information:

Title

ovulation rate

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

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Live birth rate

Description

% of of cases that result in live birth > 20 weeks pregnancy

Time Frame

6 months

Title

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

Description

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

Time Frame

3 months

Title

Endometrial thickness

Description

Measuring endometrial thickness in mm in both study arms at the time of ovulation trigerring to see if there is difference

Time Frame

3 months

Title

serum Estradiol(E2)

Description

serum level of E2 is measured in both groups at the time of ovulation triggerring to test for differences

Time Frame

3 months

Title

incidence of multiple pregnancy

Description

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

Time Frame

3 months

Title

costs per cycle

Description

Time Frame

3 months

Title

cost effectiveness ratio

Description

Time Frame

6 months

Title

clinical and biochemical predictors of response to treatment

Time Frame

6 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

38 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohamad E Ghanem, MD

Organizational Affiliation

Mansoura Integrated Fertility Center

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Mohammad A Emam, MD

Organizational Affiliation

Mansoura Integrated Fertility Center

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Mohamad E Ghanem, MD

Organizational Affiliation

Mansoura Integrated Fertility Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mansoura Integrated fertility Center

City

Mansoura

State/Province

Dekahlia

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

19809318

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.

Results Reference

background

PubMed Identifier

17185789

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.

Results Reference

background

PubMed Identifier

24014214

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. Erratum In: J Assist Reprod Genet. 2014 Apr;31(4):505-6.

Results Reference

derived

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

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