InfertilityPhase 4NCT00802360
MENOPUR® Versus FOLLISTIM®
A Phase 4 study testing Menotropin, Progestrone vaginal insert and follitropin beta in people with Infertility, run by Ferring Pharmaceuticals at 7 sites in United States.
Trial summary
To compare the efficacy and safety of highly purified menotropin (Menopur®) with that of follitropin beta (FOLLISTIM®) in patients who are undergoing gonadotropin-releasing hormone (GnRH) antagonist in vitro fertilization (IVF) cycles Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Menotropin, Progestrone vaginal insert and follitropin beta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 7 sitesUnited States
- Study dates
- Dec 2008to Jan 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pre-menopausal females between the ages of 18 and 42 years
- Body mass index (BMI) of 18-34
- Early follicular phase (day 2-4) Follicle stimulating hormone (FSH) <15 IU/L and Estradiol (E2) within normal limits
- Documented history of infertility (e.g., unable to conceive for at least one year, or for 6 months for women >38 years of age, or bilateral tubal occlusion or absence, or male factor but excluding severe male factor requiring invasive or surgical sperm retrieval. Donor sperm may be used.)
- Transvaginal ultrasound at screening consistent with findings adequate for assisted reproductive technology (ART) with respect to uterus and adnexa
- Signed informed consent
Who cannot join
- Gestational or surrogate carrier, donor oocyte
- Presence of any clinically relevant systemic disease (e.g., insulin-dependent diabetes mellitus, uterine cancer)
- Surgical or medical condition which, in the judgment of the Investigator or Sponsor, may interfere with absorption, distribution, metabolism, or excretion of the drugs to be used
- Previous In vitro fertilization (IVF) or Assisted reproductive technology (ART) failure due to a poor response to gonadotropins. Poor response is defined as development of 2 mature follicles or history of >2 previous failed in vitro fertilization (IVF) cycles.
- History of recurrent pregnancy loss (>2).
- Presence of abnormal uterine bleeding of undetermined origin
Show all 10Show fewer
- Current or recent substance abuse, including alcohol or smoking >10 cigarettes per day
- Refusal or inability to comply with the requirements of the Protocol for any reason, including scheduled clinic visits and laboratory tests
- Participation in any experimental drug study within 30 days prior to Screening
- Severe male factor requiring invasive or surgical sperm retrieval (e.g., microsurgical epididymal sperm aspiration [MESA], testicular sperm extraction [TESE])
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
A Woman's Center for Reproductive Medicine
Baton Rouge, Louisiana, 70815
Center for Assisted Reproduction
Bedford, Texas, 76022
Women's Medical Research Group, LLC
Clearwater, Florida, 33759
Conceptions Reproductive Associates of Colorado
Littleton, Colorado, 80129
The Advanced IVF Institute; Charles E. Miller, MD & Associates
Naperville, Illinois, 60540
Huntington Reproductive Center
Pasadena, California, 91105
San Diego Fertility Center
San Diego, California, 92130
About this study
Official title: A Multi-Center, Randomized, Open-Label Evaluation of MENOPUR® Versus FOLLISTIM® in GnRH Antagonist Cycles
To compare the efficacy and safety of highly purified menotropin (Menopur®) with that of follitropin beta (FOLLISTIM®) in patients who are undergoing gonadotropin-releasing hormone (GnRH) antagonist in vitro fertilization (IVF) cycles
Read the detailed description
This multicenter, randomized, open-label exploratory study will be performed in approximately 200 healthy females undergoing in vitro fertilization (IVF). Each study center will follow its study center standard practice for in vitro fertilization (IVF) within the study parameters as noted in this protocol. The study centers will use marketed products purchased from Schraft's Pharmacy for all phases of the study (down-regulation, stimulation, ovulation induction, and luteal support). Subjects will be randomly assigned prior to the start of stimulation to highly purified menotropin (Menopur®) or follitropin beta (Follistim Pen®) for stimulation and progesterone vaginal insert (Endometrin®) or progesterone in oil for luteal support. Subjects will return to the study center for regular scheduled clinic visits as required per in vitro fertilization (IVF) protocol at the site and at specified time periods during the cycle for estradiol (E2), progesterone (P4) and human chorionic gonadotropin (hCG) tests, and first serum pregnancy test. All subjects will be required to complete a final study visit at completion of luteal support or negative serum pregnancy test following embryo transfer.
- Conditions
- Infertility
- Being tested
- Menotropin, Progestrone vaginal insert, follitropin beta, Progesterone in oil, Ganirelix
- Keywords
- Healthy, pre-menopausal women, age 18-42 with a history of infertility and requiring IVF
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenotropinDrug
Also called highly purified menotropins, Menopur®, hMG
225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days until human chorionic gonadotropin (hCG) criteria are met.
Progestrone vaginal insertDrug
Also called progesterone, Endometrin®
100 mg progesterone vaginal insert 2 or 3 times daily (BID or TID) (start on the day after oocyte retrieval) until 10 weeks gestation or confirmation of negative pregnancy test.
follitropin betaDrug
Also called Follistim Pen®, Follistim®
225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in oilDrug
50 mg by intramuscular injection once per day, starting on the day after oocyte retrieval until 10 weeks gestation or confirmation of negative pregnancy test.
GanirelixDrug
Also called ganirelix acetate, GnRH antagonist
Ganirelix acetate 250 µg as a daily subcutaneous injection starting on day 6 and continuing until hCG criteria were met.
| Study group | Role | What they receive |
|---|---|---|
| Menopur/Endometrin | Experimental | Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progestrone vaginal insert (Endometrin®) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained. Receives: Drug: Menotropin; Drug: Progestrone vaginal insert; Drug: Ganirelix |
| Menopur/Progesterone in Oil | Experimental | Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in Oil injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained. Receives: Drug: Menotropin; Drug: Progesterone in oil; Drug: Ganirelix |
| Follistim/Endometrin | Active comparator | Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progestrone vaginal insert (Endometrin®) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained. Receives: Drug: Progestrone vaginal insert; Drug: follitropin beta; Drug: Ganirelix |
| Follistim/Progesterone in Oil | Active comparator | Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.
Progesterone in Oil injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained. Receives: Drug: follitropin beta; Drug: Progesterone in oil; Drug: Ganirelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Ongoing Pregnancy at Week 8
The ongoing pregnancy was defined as a positive fetal heart movement (motion) at approximately six weeks of gestation and confirmed in a follow-up pregnancy ultrasound.
Measured: Week 8 (Week 6 of gestation)
Secondary outcomes (10)
Number of Follicles Observed at Day 15
The mean number of follicles observed in both ovaries at the last transvaginal ultrasound in the stimulation phase.
Measured: Day 15
Number of Oocytes Retrieved at Day 18
The mean number of oocytes retrieved within 34-36 hours of human chorionic gonadotropin (hCG) administration.
Measured: Approximately Day 18
Proportion of Oocytes Fertilized of the Total Number of Oocytes Retrieved
The proportion of the number of oocytes inseminated (fertilized) of the total number of oocytes retrieved.
Measured: Approximately Day 19
Number of Embryos Transferred at Three Stages of Development
The number of embryos, morula and blastocytes transferred to the study participant on either day 3 or day 5 following fertilization.
Measured: Approximately Day 24
Number of Embryos Frozen at Day 24
The number of embryos that were not transferred but instead were frozen for future use.
Measured: Approximately Day 24
Participants With Cycle Cancellation Following One In Vitro Fertilization (IVF) Treatment Cycle
A count of participants whose discontinuation was clearly documented on the study completion/termination form as 1) due to cycle cancelled or 2) cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS).
Measured: Day 1 to Day 24
Participants With Biochemical Pregnancy at Day 38
Biochemical pregnancy is a positive β-hCG pregnancy test 12-14 days post embryo transfer.
Measured: approximately day 38 (Day 14 post embryo transfer)
Participants With Clinical Pregnancy at Week 7
Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.
Measured: approximately week 7
Participants With Adverse Events (AEs), Including Ovarian Hyperstimulation Syndrome (OHSS)
Number of participants with adverse events (AEs) that started after first treatment. Severity used a three point scale:
mild=awareness of signs/symptoms, but no disruption of usual activity moderate=event sufficient to affect usual activity (disturbing) severe=event causes inability to work or perform usual activities (unacceptable)
Relatedness to study treatment used a four point scale: unrelated, unlikely, possible, probable.
Seriousness refers to death, hospitalization, a life-threatening experience, persistent or significant disability/incapacity, or congenital anomaly.
Measured: Day 1 - week 12
Number of Live Births
Measured: Approximately 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionNov 2009
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00802360
- Sponsor's protocol ID
- 2008-04
- Status last verified
- Oct 2011
- First submitted
- 3 Dec 2008
- Last updated
- 2 Nov 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Open-Label Evaluation of MENOPUR® Versus FOLLISTIM® in GnRH Antagonist Cycles
- ClinicalTrials.gov ID
- NCT00802360
- Acronym / sponsor ID
- 2008-04
- Conditions
- Infertility
- Keywords
- Healthy, pre-menopausal women, age 18-42 with a history of infertility and requiring IVF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 4 Dec 2008 (estimated)
- Results
- Posted 30 Aug 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy and safety of highly purified menotropin (Menopur®) with that of follitropin beta (FOLLISTIM®) in patients who are undergoing gonadotropin-releasing hormone (GnRH) antagonist in vitro fertilization (IVF) cycles
Detailed description
This multicenter, randomized, open-label exploratory study will be performed in approximately 200 healthy females undergoing in vitro fertilization (IVF). Each study center will follow its study center standard practice for in vitro fertilization (IVF) within the study parameters as noted in this protocol. The study centers will use marketed products purchased from Schraft's Pharmacy for all phases of the study (down-regulation, stimulation, ovulation induction, and luteal support). Subjects will be randomly assigned prior to the start of stimulation to highly purified menotropin (Menopur®) or follitropin beta (Follistim Pen®) for stimulation and progesterone vaginal insert (Endometrin®) or progesterone in oil for luteal support. Subjects will return to the study center for regular scheduled clinic visits as required per in vitro fertilization (IVF) protocol at the site and at specified time periods during the cycle for estradiol (E2), progesterone (P4) and human chorionic gonadotropin (hCG) tests, and first serum pregnancy test. All subjects will be required to complete a final study visit at completion of luteal support or negative serum pregnancy test following embryo transfer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Menopur/Endometrin | Experimental | Drug: Menotropin, Drug: Progestrone vaginal insert, Drug: GanirelixHighly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progestrone vaginal insert (Endometrin®) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained. |
| Menopur/Progesterone in Oil | Experimental | Drug: Menotropin, Drug: Progesterone in oil, Drug: GanirelixHighly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in Oil injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained. |
| Follistim/Endometrin | Active comparator | Drug: Progestrone vaginal insert, Drug: follitropin beta, Drug: GanirelixFollitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progestrone vaginal insert (Endometrin®) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained. |
| Follistim/Progesterone in Oil | Active comparator | Drug: follitropin beta, Drug: Progesterone in oil, Drug: GanirelixFollitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met. Progesterone in Oil injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained. |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pre-menopausal females between the ages of 18 and 42 years
- Body mass index (BMI) of 18-34
- Early follicular phase (day 2-4) Follicle stimulating hormone (FSH) <15 IU/L and Estradiol (E2) within normal limits
- Documented history of infertility (e.g., unable to conceive for at least one year, or for 6 months for women >38 years of age, or bilateral tubal occlusion or absence, or male factor but excluding severe male factor requiring invasive or surgical sperm retrieval. Donor sperm may be used.)
- Transvaginal ultrasound at screening consistent with findings adequate for assisted reproductive technology (ART) with respect to uterus and adnexa
Key exclusion criteria (10 listed)
- Gestational or surrogate carrier, donor oocyte
- Presence of any clinically relevant systemic disease (e.g., insulin-dependent diabetes mellitus, uterine cancer)
- Surgical or medical condition which, in the judgment of the Investigator or Sponsor, may interfere with absorption, distribution, metabolism, or excretion of the drugs to be used
- Previous In vitro fertilization (IVF) or Assisted reproductive technology (ART) failure due to a poor response to gonadotropins. Poor response is defined as development of 2 mature follicles or history of >2 previous failed in vitro fertilization (IVF) cycles.
- History of recurrent pregnancy loss (>2).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MenotropinAlso: highly purified menotropins, Menopur®, hMG225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days until human chorionic gonadotropin (hCG) criteria are met. | Drug | Menopur/Endometrin, Menopur/Progesterone in Oil |
| Progestrone vaginal insertAlso: progesterone, Endometrin®100 mg progesterone vaginal insert 2 or 3 times daily (BID or TID) (start on the day after oocyte retrieval) until 10 weeks gestation or confirmation of negative pregnancy test. | Drug | Follistim/Endometrin, Menopur/Endometrin |
| follitropin betaAlso: Follistim Pen®, Follistim®225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days until human chorionic gonadotropin (hCG) criteria are met. | Drug | Follistim/Endometrin, Follistim/Progesterone in Oil |
| Progesterone in oil50 mg by intramuscular injection once per day, starting on the day after oocyte retrieval until 10 weeks gestation or confirmation of negative pregnancy test. | Drug | Follistim/Progesterone in Oil, Menopur/Progesterone in Oil |
| GanirelixAlso: ganirelix acetate, GnRH antagonistGanirelix acetate 250 µg as a daily subcutaneous injection starting on day 6 and continuing until hCG criteria were met. | Drug | Follistim/Endometrin, Follistim/Progesterone in Oil, Menopur/Endometrin, Menopur/Progesterone in Oil |
Primary outcome
Percentage of Participants With Ongoing Pregnancy at Week 8
Time frame: Week 8 (Week 6 of gestation)
The ongoing pregnancy was defined as a positive fetal heart movement (motion) at approximately six weeks of gestation and confirmed in a follow-up pregnancy ultrasound.
10 secondary outcomes
Number of Follicles Observed at Day 15
Time frame: Day 15
Number of Oocytes Retrieved at Day 18
Time frame: Approximately Day 18
Proportion of Oocytes Fertilized of the Total Number of Oocytes Retrieved
Time frame: Approximately Day 19
Number of Embryos Transferred at Three Stages of Development
Time frame: Approximately Day 24
Number of Embryos Frozen at Day 24
Time frame: Approximately Day 24
Participants With Cycle Cancellation Following One In Vitro Fertilization (IVF) Treatment Cycle
Time frame: Day 1 to Day 24
Participants With Biochemical Pregnancy at Day 38
Time frame: approximately day 38 (Day 14 post embryo transfer)
Participants With Clinical Pregnancy at Week 7
Time frame: approximately week 7
Participants With Adverse Events (AEs), Including Ovarian Hyperstimulation Syndrome (OHSS)
Time frame: Day 1 - week 12
Number of Live Births
Time frame: Approximately 10 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Infertility
RecruitingPhase 3
A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)
Infertility
Active, not recruitingObservational study
Fresh Versus Vitrified-Warmed Donor Oocytes: Embryological and Clinical Outcomes
Infertility, Donor Oocyte Assisted Reproduction
RecruitingObservational study
Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
Infertility
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
Not yet recruiting
Implementing IVM for Fertility Treatment in Clinical Practice
Infertility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development Support study director
Ferring Pharmaceuticals
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Menotropin, Progestrone vaginal insert and follitropin beta in people with Infertility, run by Ferring Pharmaceuticals at 7 sites in United States.
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 6 inclusion and 10 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 2 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Ongoing Pregnancy at Week 8 (time frame: Week 8 (Week 6 of gestation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2011.