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InfertilityPhase 4MEGASET HRNCT02554279

MENOPUR® in a Gonadotropin-Releasing Hormone (GnRH) Antagonist Cycle With Single-Blastocyst Transfer in a High Responder Subject Population

A Phase 4 study testing menotropin and recombinant FSH in people with Infertility, run by Ferring Pharmaceuticals at 35 sites in United States.

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

The purpose of this trial is to demonstrate non-inferiority of MENOPUR® versus recombinant Follicle Stimulating Hormone (rFSH) (Gonal-f®) with respect to ongoing pregnancy rate in women undergoing controlled ovarian stimulation (COS) following GnRH treatment. Read more about this study

Who is it for?
Ages 21 to 35 years, women only
Conditions the study is for
Infertility
What is being tested?
menotropin and recombinant FSH
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
620 participants
Where
35 sitesUnited States
Study dates
31 Aug 2015to 2 Feb 2017
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 21 to 35 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Females aged 21 to 35 years with regular ovulatory menstrual cycles of 21 to 45 days, with a Body Mass Index (BMI) between 18 and 30 kg/m2 who desire pregnancy.
  • Subjects must be high responders, defined as subjects who have a serum anti-Müllerian hormone (AMH) ≥5 ng/mL at screening.
  • Documented history of infertility (e.g., unable to conceive for at least 12 months or for at least 6 months if receiving donor sperm) with a Day 2 or Day 3 serum FSH level between 1 and 12 IU/L (inclusive), the results of which should be obtained within 6 months prior to randomization.

Who cannot join

  • Known stage III-IV endometriosis (American Society for Reproductive Medicine, 2012).
  • History of recurrent miscarriage not followed by a live birth (recurrent is defined as two (2) or more consecutive miscarriages).
  • 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 cycle cancellations prior to oocytes retrieval due to poor response.

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

United States35 sites

  • Abington Hospital, Jefferson Health

    Abington, Pennsylvania

  • Reproductive Medicine Associates of New Jersey

    Basking Ridge, New Jersey

  • Center for Assisted Reproduction

    Bedford, Texas

  • Idaho Center for Reproductive Medicine

    Boise, Idaho

  • Main Line Fertility Center

    Bryn Mawr, Pennsylvania

  • Reach

    Charlotte, North Carolina

  • Fertility Centers of Illinois

    Chicago, Illinois

  • Women's Medical Research Group

    Clearwater, Florida

  • HRC Fertility

    Encino, California

  • InVia Fertility Specialists, SC

    Hoffman Estates, Illinois

  • Fertility Institute of Hawaii

    Honolulu, Hawaii

  • Houston Fertility Institute

    Houston, Texas

  • Fertility Center of Las Vegas

    Las Vegas, Nevada

  • IVF New England

    Lexington, Massachusetts

  • Colorado Center for Reproductive Medicine (CCRM)

    Lone Tree, Colorado

  • California Fertility Partners

    Los Angeles, California

  • Fertility and IVF Center of Miami

    Miami, Florida

  • Coastal Fertility Specialists

    Mt. Pleasant, South Carolina

  • The Advanced IVF Institute

    Naperville, Illinois

  • Reproductive Associates of Delaware

    Newark, Delaware

  • The Jones Institute for Reproductive Medicine

    Norfolk, Virginia

  • Center for Reproductive Medicine

    Orlando, Florida

  • Utah Fertility Center

    Pleasant Grove, Utah

  • Carolina Conceptions

    Raleigh, North Carolina

  • Virginia Center for Reproductive Medicine

    Reston, Virginia

  • Shady Grove Fertility Centers

    Rockville, Maryland

  • Reproductive Care Center

    Sandy City, Utah

  • Georgia Reproductive Specialists

    Sandy Springs, Georgia

  • Bloom Reproductive Institute

    Scottsdale, Arizona

  • Seattle Reproductive Medicine

    Seattle, Washington

  • The Reproductive Medicine Group

    Tampa, Florida

  • Fertility Treatment Center

    Tempe, Arizona

  • Shady Grove Fertility

    Towson, Maryland

  • Boston IVF

    Waltham, Massachusetts

  • Center of Reproductive Medicine

    Webster, Texas

Other trials in United States

About this study

Official title: A Randomized, Assessor-blind Trial Comparing MENOPUR® (Menotropins for Injection) and Recombinant FSH (Follicle Stimulating Hormone) in a GnRH Antagonist Cycle With Single-Blastocyst Transfer in a High Responder Subject Population

The purpose of this trial is to demonstrate non-inferiority of MENOPUR® versus recombinant Follicle Stimulating Hormone (rFSH) (Gonal-f®) with respect to ongoing pregnancy rate in women undergoing controlled ovarian stimulation (COS) following GnRH treatment.

Conditions
Infertility
Being tested
menotropin, recombinant FSH
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 Menopur®

  • recombinant FSHDrug

    Also called Gonal-f®

Study groups in NCT02554279
Study groupRoleWhat they receive
menotropinExperimentalmenotropins for injection
Receives: Drug: menotropin
recombinant FSHActive comparatorNot described
Receives: Drug: recombinant FSH

What is being measured

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

  1. Ongoing Pregnancy Rate

    Defined as the percentage of participants with the presence of at least 1 intrauterine pregnancy with a detectable fetal heartbeat at 10-11 weeks of gestation.

    Measured: 8-9 weeks after blastocyst transfer in the fresh cycle

Secondary outcomes (11)

  1. Positive β-human Chorionic Gonadotropin (hCG) Rate

    Defined as the percentage of participants with 2 positive β-hCG tests within 2 days in serum.

    Measured: First test approximately 10-14 days after blastocyst transfer in the fresh cycle, with a second test approximately 2 days later if first test was positive

  2. Clinical Pregnancy Rate

    Defined as percentage of participants with transvaginal ultrasound (TVUS) showing at least 1 intrauterine gestational sac with fetal heart beat at 6-7 weeks of gestation.

    Measured: 4-5 weeks after blastocyst transfer in the fresh cycle

  3. Early Pregnancy Loss

    Defined as participants with 2 positive β-hCG tests but no ongoing pregnancy at 10-11 weeks of gestation in the fresh cycle. Percentage of participants with early pregnancy loss is presented.

    Measured: At 10-11 weeks of gestation in the fresh cycle

  4. Follicular Development as Assessed by TVUS

    Defined as average follicle size and average size of 3 largest follicles.

    Measured: On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days)

  5. Follicular Development as Assessed by TVUS

    Defined as percentage of participants with follicles having a diameter of ≤9 mm, 10-11 mm, 12-14 mm, 15-16 mm, and ≥17 mm.

    Measured: On stimulation Day 6 and last day of stimulation (a maximum of 20 stimulation days)

  6. Number of Oocytes Retrieved

    Measured: At oocyte retrieval visit (approximately 36 hours after hCG administration)

  7. Number of Metaphase II Oocytes

    Measured: At oocyte retrieval visit (approximately 36 hours after hCG administration)

  8. Fertilization Rate

    Defined as 100 times the ratio of number of fertilized 2 pronuclei oocytes to the number of oocytes retrieved, for each participant.

    Measured: On day 1 post-insemination

  9. Quality of Embryos

    Assessed by blastomere uniformity, cell size, the degree of fragmentation, and visual signs of multinucleation.

    Measured: 3 days after oocyte retrieval

  10. Quality of Embryos

    Assessed by cleavage stage.

    Measured: 3 days after oocyte retrieval

  11. Quality of Blastocysts

    Assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring was based on the classification system by Gardner and Schoolcraft, with additional categories for inner cell mass (degenerative or no inner cell mass) and trophectoderm (degenerative or very large cell).

    Measured: 5 days after oocyte retrieval

Timeline

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

  1. First posted18 Sep 2015 (estimated)
  2. Study start31 Aug 2015
  3. Primary completion26 Jan 2017
  4. Study completion2 Feb 2017

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
620 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02554279
Sponsor's protocol ID
000205
Acronym
MEGASET HR
Status last verified
Mar 2019
First submitted
9 Sep 2015
Last updated
21 Sep 2023
Data monitoring committee
No

Publications

  • Khair A, Brown T, Markert M, Barsoe CR, Daftary GS, Heiser PW. Highly Purified Human Menopausal Gonadotropin (HP-hMG) Versus Recombinant Follicle-Stimulating Hormone (rFSH) for Controlled Ovarian Stimulation in US Predicted High-Responder Patients: A Cost-Comparison Analysis. Pharmacoecon Open. 2023 Sep;7(5):851-860. doi: 10.1007/s41669-023-00429-8. Epub 2023 Jul 22.

    PubMed 37480456

  • Robins JC, Khair AF, Widra EA, Alper MM, Nelson WW, Foster ED, Sinha A, Ando M, Heiser PW, Daftary GS. Economic evaluation of highly purified human menotropin or recombinant follicle-stimulating hormone for controlled ovarian stimulation in high-responder patients: analysis of the Menopur in Gonadotropin-releasing Hormone Antagonist Single Embryo Transfer-High Responder (MEGASET-HR) trial. F S Rep. 2020 Nov 10;1(3):257-263. doi: 10.1016/j.xfre.2020.09.010. eCollection 2020 Dec.

    PubMed 34223253

  • Witz CA, Daftary GS, Doody KJ, Park JK, Seifu Y, Yankov VI, Heiser PW; Menopur in GnRH Antagonist Cycles with Single Embryo Transfer - High Responder (MEGASET-HR) Trial Group. Randomized, assessor-blinded trial comparing highly purified human menotropin and recombinant follicle-stimulating hormone in high responders undergoing intracytoplasmic sperm injection. Fertil Steril. 2020 Aug;114(2):321-330. doi: 10.1016/j.fertnstert.2020.03.029. Epub 2020 May 13.

    PubMed 32416978

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing menotropin and recombinant FSH in people with Infertility, run by Ferring Pharmaceuticals at 35 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 3 inclusion and 3 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 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 2 Mar 2018). 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?

Ongoing Pregnancy Rate (time frame: 8-9 weeks after blastocyst transfer in the fresh cycle). 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 NCT02554279, 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 21 Sep 2023.

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