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InfertilityPhase 3NCT00230815

A Phase 3b Study to Evaluate Subject Satisfaction With Follitropin Alfa Injection in Oligoanovulatory Infertile Women Undergoing Ovulation Induction

A Phase 3 study testing Follitropin alfa injected by Pen device and Recombinant Human Choriogonadotropin (r-hCG) in people with Infertility, run by EMD Serono.

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

This is a prospective, open-label, multicenter, trial evaluating subject satisfaction and efficacy with follitropin alfa injection applied by Pen device compared with the subject's previous experience with injectable gonadotropins in oligoanovulatory infertile women undergoing ovulation induction Read more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Infertility
What is being tested?
Follitropin alfa injected by Pen device and Recombinant Human Choriogonadotropin (r-hCG)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
No sites listed yet
Study dates
Jul 2004to Nov 2005
Phase
Phase 3
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 40 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Infertile woman wishing to conceive who has had at least 1 previous cycle of treatment with injectable gonadotropins within the past 6 months, excluding treatment with any gonadotropin multi-dose formulation in vials or administered by Pen device, whose physician has recommended that she undergo ovulation induction. This inclusion criterion is modified to include subjects who had previous treatment with any gonadotropin multi-dose formulation in vials, excluding those gonadotropins administered by a Pen device
  • Premenopausal and aged 18-40 years, inclusive
  • Ovulatory dysfunction as defined by any of the following (a) usual cycle length less than (<) 21 or greater than (>) 35 days with at least 6 menses per year (b) usual cycle length > 35 days with less than 6 menses per year. Subjects in this group must have a positive response to a progesterone challenge within the past 6 months or during the screening period
  • Spontaneous menses or a positive response to progestin withdrawal within 6 months of the start of gonadotropin therapy or positive response to clomiphene citrate withdrawal at least 30 days prior to start of gonadotropin therapy is acceptable to demonstrate induced menses
  • Normal Papanicolaou (PAP) smear within 6 months prior to initial visit
  • Male partner with an acceptable semen analysis within 6 months prior to study entry, according to the standard practice at the clinic, for ovulation induction. Use of donor sperm is acceptable
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  • Body mass index (BMI) less than 35.0 kilogram per square meter (kg/m^2). BMI = Body Weight / Height x Height (BMI is equal to body weight [kilogram {kg}] divided by Height * Height [square meter {m^2}])
  • Patency and apparent normality of at least 1 fallopian tube with an ipsilateral functional ovary, as documented by an hysterosonogram or hysterosalpingography (HSG) within 3 years prior to study entry
  • Local laboratory screening results demonstrating the following, within the past year: (a) prolactin within normal limits (b) Follicle stimulating hormone (FSH) within the normal limit for the early follicular phase at the local laboratory (c) thyroid stimulating hormone (TSH) within normal limits. Subjects with low TSH levels who were receiving replacement therapy could be enrolled at the discretion of the Investigator
  • Been willing and able to comply with the protocol for the duration of the study
  • Voluntarily provided written informed consent and a subject authorization under Health Insurance Portability and Accountability Act (HIPAA), prior to any study-related procedure not part of normal medical care, with the understanding that consent could be withdrawn by the subject at any time without prejudice to their future medical care. The male partner must also have provided a written subject authorization under HIPAA

Who cannot join

  • Clinically significant systemic disease or clinically significant abnormal hematology, chemistry, or urinalysis results at screening
  • Previous treatment with any gonadotropin multi-dose formulation in vials or administered by Pen device in the past 6 months
  • Any significant allergic disease, which in the opinion of the Investigator could interfere with study treatment
  • Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus
  • Prior severe Ovarian Hyperstimulation Syndrome (OHSS)
  • Significant allergic response to gonadotropin preparations
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  • Ongoing pregnancy, any pregnancy within 3 months prior to study entry, or any contraindication to pregnancy or carrying pregnancy to term
  • Clinically significant abnormal findings evident on a transvaginal pelvic ultrasound performed within 2 cycles (maximum 90 days) of study entry
  • Poor response in a prior gonadotropin stimulation cycle, defined as an estradiol level < 100 pg/mL per mature follicle (>=16 mm mean diameter)
  • Prior excessive response to gonadotropin stimulation as defined by development of >3 mature follicles at a treatment dose of 75 IU FSH
  • Treatment with gonadotropins, clomiphene citrate, insulin-sensitizing agents (e.g., metformin, Avandia®) or Gonadotropin Releasing Hormone (GnRH) analogs within 1 month prior to study entry
  • Hypothyroidism (untreated). Subjects with low Thyroid Stimulating Hormone (TSH) levels who were receiving replacement therapy (e.g., Synthroid) could be enrolled at the discretion of the Investigator if local laboratory results demonstrated satisfactory thyroid function
  • Hyperprolactinemia (untreated)
  • Abnormal, undiagnosed, gynecological bleeding
  • Known current American Society Reproductive Medicine (ASRM) Stage 3 or 4 endometriosis
  • A residual ovarian cyst with a mean diameter >25 mm or an estradiol (E2) >100 pg/mL at the baseline examination
  • Three or more consecutive pregnancy losses, due to any cause
  • Known current substance abuse (including smokers consuming more than 5 cigarettes/day)
  • Previous participation (within 3 months prior to study entry) in another investigational drug or drug delivery system trial

About this study

Official title: A Phase IIIb, Prospective, Multicenter Trial to Evaluate Subject Satisfaction With Follitropin Alfa Injection Applied by Pen Device Compared With Other Injectable Gonadotropins in Oligoanovulatory Infertile Women Undergoing Ovulation Induction

This is a prospective, open-label, multicenter, trial evaluating subject satisfaction and efficacy with follitropin alfa injection applied by Pen device compared with the subject's previous experience with injectable gonadotropins in oligoanovulatory infertile women undergoing ovulation induction

Conditions
Infertility
Being tested
Follitropin alfa injected by Pen device, Recombinant Human Choriogonadotropin (r-hCG)
Keywords
Oligoanovulatory infertility, Follitropin alfa, Pen device, Gonal-f®, Recombinant Human Choriogonadotropin (r-hCG), Ovidrel®
Medical subject headings
Infertility

What participants receive

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

  • Follitropin alfa injected by Pen deviceDevice

    Also called Gonal-f®

    Follitropin alfa will be injected subcutaneously by Pen device at a dose of 75 International Unit (IU) and 150 IU in subjects aged 18-34 and 35-40 years, respectively, for 5 days. Dose will be adjusted on stimulation Day 6 until ovulation triggering criteria will met.

  • Recombinant Human Choriogonadotropin (r-hCG)Device

    Also called Ovidrel®, Choriogonadotropin alfa

    Recombinant Human Choriogonadotropin (r-hCG) injection will be administered as a single dose of 250 microgram subcutaneously when at least 1 follicle, but not more than 3 follicles, reached a mean diameter greater than or equal to (>=)17 mm and estradiol levels are approximately 150 picogram per milliliter (pg/mL) per mature follicle.

Study groups in NCT00230815
Study groupRoleWhat they receive
Follitropin alfa injected by Pen deviceExperimentalNot described
Receives: Device: Follitropin alfa injected by Pen device; Device: Recombinant Human Choriogonadotropin (r-hCG)

What is being measured

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

  1. Percentage of subjects who prefer Gonal-f® Pen device compared to previously used injection for gonadotropin treatment

    Measured: Stimulation Day 6

Secondary outcomes (6)

  1. Number of subjects with categorical score on subject satisfaction questionnaire

    Measured: Stimulation Day 1 and Day 6

  2. Percentage of subjects with induced ovulation

    Measured: Stimulation Day 1 up to r-hCG administration day (end of stimulation cycle {approximately 6 days})

  3. Number of follicles categorized by size on r-hCG administration day

    Measured: r-hCG administration day (end of stimulation cycle {approximately 6 days})

  4. Duration of follitropin alfa treatment

    Measured: Stimulation Day 1 up to r-hCG administration day (end of stimulation cycle {approximately 6 days})

  5. Cumulative dose of follitropin alfa administered

    Measured: Stimulation Day 1 up to r-hCG administration day (end of stimulation cycle {approximately 6 days})

  6. Percentage of subjects with pregnancy

    Measured: Day 35-42 post r-hCG administration day (end of stimulation cycle {approximately 6 days})

Timeline

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

  1. First posted3 Oct 2005 (estimated)
  2. Study startJul 2004
  3. Primary completionNov 2005
  4. Study completionNov 2005

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00230815
Sponsor's protocol ID
24785
Status last verified
Nov 2013
First submitted
29 Sep 2005
Last updated
28 Nov 2013
Results posted
No

Publications

  • Somkuti SG, Schertz JC, Moore M, Ferrande L, Kelly E; Gonal-F Prefilled Pen in OI Study 24785 Group. Patient experience with follitropin alfa prefilled pen versus previously used injectable gonadotropins for ovulation induction in oligoanovulatory women. Curr Med Res Opin. 2006 Oct;22(10):1981-96. doi: 10.1185/030079906X132604.

    PubMed 17022858

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Follitropin alfa injected by Pen device and Recombinant Human Choriogonadotropin (r-hCG) in people with Infertility, run by EMD Serono.

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 11 inclusion and 19 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 28 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Percentage of subjects who prefer Gonal-f® Pen device compared to previously used injection for gonadotropin treatment (time frame: Stimulation Day 6). 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 NCT00230815, which also lists 1 linked publication.

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 28 Nov 2013.

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