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Polycystic Ovary SyndromeNCT01212263

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

A study testing Step-up HP u FSH and Clomiphine citrate plus low dose uFSH in people with Polycystic Ovary Syndrome, run by Mansoura Integrated Fertility Center at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 38 years, women only
Conditions the study is for
Polycystic Ovary Syndrome
What is being tested?
Step-up HP u FSH and Clomiphine citrate plus low dose uFSH
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
1 siteEgypt
Study dates
Jan 2010to Sep 2012
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 38 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Mansoura Integrated fertility Center

    Al Mansurah, Dekahlia

Other trials in Egypt

About this study

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

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.

Read the 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.

Being tested
Step-up HP u FSH, Clomiphine citrate plus low dose uFSH
Keywords
PCOS, Clomiphene resistance, ovulation induction, low dose uFSH, uFSH step-up protocol
Medical subject headings
Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Step-up HP u FSHDrug

    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 uFSHDrug

    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

Study groups in NCT01212263
Study groupRoleWhat they receive
Clomiphene Citrate plus HP uFSHExperimentalStarting 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.
Receives: Drug: Clomiphine citrate plus low dose uFSH
Step-up HP uFSHActive comparatorHP 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
Receives: Drug: Step-up HP u FSH

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6 months

Secondary outcomes (8)

  1. Live birth rate

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

    Measured: 6 months

  2. 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

    Measured: 3 months

  3. Endometrial thickness

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

    Measured: 3 months

  4. serum Estradiol(E2)

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

    Measured: 3 months

  5. 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

    Measured: 3 months

  6. 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

    Measured: 3 months

  7. 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.

    Measured: 6 months

  8. clinical and biochemical predictors of response to treatment

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2010 (estimated)
  2. Study startJan 2010
  3. Primary completionSep 2012
  4. Study completionSep 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01212263
Sponsor's protocol ID
MansouraIFC1
Status last verified
May 2013
First submitted
29 Sep 2010
Last updated
30 May 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19809318

  • 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.

    PubMed 17185789

  • 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.

    PubMed 24014214

Questions about this trial

What is this clinical trial studying?

A study testing Step-up HP u FSH and Clomiphine citrate plus low dose uFSH in people with Polycystic Ovary Syndrome, run by Mansoura Integrated Fertility Center at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ovulation rate (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01212263, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2013.

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