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AzTrials

InfertilityPhase 3NCT01599494

An Efficacy and Safety Study of Corifollitropin Alfa (MK-8962) in Contrast to Recombinant FSH for Use in Controlled Ovarian Stimulation of Indian Women (P07056, Also Known as MK-8962-029)

A Phase 3 study testing MK-8962, recFSH and Ganirelix in people with Infertility, run by Organon and Co.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study, conducted in India, will be recruiting women participants who are between the ages of 18 and 42, and who have an indication for controlled ovarian stimulation (COS), but have not yet undergone in-vitro fertilization and/or intracytoplasmic sperm injection (IVF/ICSI). 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?
MK-8962, recFSH and Ganirelix
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Mar 2014to Jun 2015
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 42 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Please Note: In this trial an Indian female participant is defined as a woman 1) with native Indian parents, and 2) who is also in possession of an Indian identification card.
  • Indian woman with an indication for COS and IVF/ICSI, but has not yet undergone IVF/ICSI.
  • Body mass index (BMI) of 18.0 to 32.0 kg/m2
  • Regular spontaneous menstrual cycle (ie, a menstrual schedule that consistently occurs within a range of 24 to 35 days)
  • Access to available ejaculatory sperm. Use of donated and/or cryopreserved sperm is allowed, however sperm obtained via surgical sperm retrieval is not allowed.
  • Results documented as 'within normal limits' from clinical laboratory tests (ie, complete blood count [CBC], blood chemistries, and urinalysis).
  • Normal cervical smear result obtained within 12 months prior to study enrollment, otherwise test will be performed during screening.
  • Able to adhere to dose and study visit schedules

Who cannot join

  • Has a recent (ie, within 3 years prior to enrollment in study) history of/or
  • any active endocrine abnormality, treated or untreated.
  • Contraindicated use of gonadotropins
  • History of ovarian hyper-responsiveness
  • History of/or current polycystic ovary syndrome (PCOS)
  • Has less than 2 ovaries or has any other ovarian abnormality, including endometrioma (greater than 10 mm in size), and/or has unilateral or bilateral hydrosalpinx and/or intrauterine fibroids (5 cm in size or greater), confirmed by an ultrasound scan.
Show all 19Show fewer
  • Has any clinically relevant pathology that may impair embryo implantation or continuation of pregnancy.
  • Experienced more than three unsuccessful COS cycles for IVF/ICSI since
  • the last established ongoing pregnancy, if applicable.
  • History of non- or low ovarian response to FSH and/or Menopausal Gonadotropin (hMG) treatment.
  • History of recurrent miscarriage (ie, 3 or more)
  • Positive test results for Human Immunodeficiency Virus (HIV) or
  • Hepatitis B
  • Recent history of/or current epilepsy, thrombophilia, diabetes, cardiovascular, gastro-intestinal, hepatic, renal or pulmonary or auto-immune disease, any of which required or requires treatment.
  • Smokes or recently stopped smoking (ie, within 3 months of study enrollment)
  • History of/or active alcohol and/or drug abuse (ie, within 12 months prior to study enrollment).
  • Previous use of corifollitropin alfa
  • Use of hormonal agents known to affect ovulation or any drug/agent considered to be teratogenic
  • Use of any experimental drug within 3 months prior to study enrollment or participation in another clinical study, other than one that is survey-questionnaire based.

About this study

Official title: A Multi-center, Open-label, Randomized Trial in India to Investigate the Efficacy and Safety of a Single Injection of MK-8962 (Corifollitropin Alfa) to Induce Multifollicular Development for Controlled Ovarian Stimulation Using Daily Recombinant FSH as a Reference (Phase III, Protocol No. MK-8962-029-00 [Also Known as SCH900962, P07056])

This study, conducted in India, will be recruiting women participants who are between the ages of 18 and 42, and who have an indication for controlled ovarian stimulation (COS), but have not yet undergone in-vitro fertilization and/or intracytoplasmic sperm injection (IVF/ICSI). The study is designed to compare the difference in oocyte (immature egg cell) production after administration of the investigative drug, MK-8962 (corifollitropin alfa) + recombinant follicle stimulating hormone (recFSH), in contrast to use of only the reference drug, recFSH.

Conditions
Infertility
Being tested
MK-8962, recFSH, Ganirelix, human Chorionic Gonadotropin (hCG), Progesterone
Medical subject headings
Infertility

What participants receive

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

  • MK-8962Drug

    Also called Corifollitropin alfa

    MK-8962 is supplied in a ready-to-use prefilled syringe containing

    100 microgram (μg) or 150 μg corifollitropin alfa per 0.5 mL. Participants are randomized to receive a single subcutaneous (SC) injection of MK-8962 in the abdominal wall on Cycle Day 2 or Cycle Day 3. Dose of administered MK-8962 is weight-based. Participants who weigh 60 kilograms (kg) or less will be given 100 μg MK-8962 and those who weigh more than 60 kg will be given 150 μg MK-8962.

  • recFSHDrug

    Also called follitropin beta

    Recombinant Follicle Stimulating Hormone (recFSH) will be supplied as a ready-to-use solution in a 600 IU cartridge for SC injection via the recFSH Pen. Starting on Day 2 or 3 of the menstrual cycle (Stimulation Day 1), recFSH will be administered daily, each morning, via injections in the abdominal wall. A starting dose of between 150 - 300 IU will be administered and is fixed for the first week of stimulation. After 6 days, and based on each participant's individual response, the Investigator may decide to reduce the fixed dose for the remainder of the study. The maximum duration of stimulation is 19 days; recFSH will not be administered on the Day of hCG Administration.

  • GanirelixDrug

    Also called Ganirelix acetate or Ganirelix diacetate

    0.25 mg/day SC injection in the upper leg, administered on Stimulation Day 5 up to and including Day of hCG Administration

  • human Chorionic Gonadotropin (hCG)Drug

    Also called human Chorionic Gonadotrophin

    Single dose of 10,000 or 5,000 IU hCG, administered via SC injection on Day of hCG Administration.

  • ProgesteroneDrug

    Also called Crinone®

    Crinone 8% (90 mg) gel administered intravaginally via a single-use, one piece polyethylene vaginal applicator once-daily on Day of Oocyte Pick-up or 1 day later and continued for at least 6 weeks or either up to menses or up to a negative pregnancy test performed at least 18 days after Day of Oocyte Pick-up.

Study groups in NCT01599494
Study groupRoleWhat they receive
Single-Dose MK-8962 + recFSHExperimentalNot described
Receives: Drug: MK-8962; Drug: recFSH; Drug: Ganirelix; Drug: human Chorionic Gonadotropin (hCG); Drug: Progesterone
Reference Group recFSH onlyActive comparatorNot described
Receives: Drug: recFSH; Drug: Ganirelix; Drug: human Chorionic Gonadotropin (hCG); Drug: Progesterone

What is being measured

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

  1. Number of Cumulus-Oocyte-Complexes Retrieved During Oocyte Pick-up

    The criterion of hCG administration is defined as three or more follicles ≥17 mm, confirmed by ultrasound. Oocyte pick up occurs 34-36 hours after the Day of hCG Administration, based on confirmed ultrasound findings.

    Measured: 34 to 36 hours after Day of Administration of Human Chorionic Gonadotropin (hCG)

Secondary outcomes (3)

  1. Confirmation of Vital Pregnancy

    Per study protocol, vital pregnancy is defined as the presence of at least one fetus with heart activity at approximately 5 weeks (ie, ~ 35 days) after Day of Embryo Transfer in the COS treatment cycle.

    Measured: Post treatment; at 35 days from Day of Embryo Transfer

  2. Percentage of Participants with Moderate or Severe Ovarian Hyperstimulation Syndrome (OHSS)

    Per study protocol, OHSS is defined as more than 30 follicles ≥11 mm in size demonstrated by ultrasound.

    Measured: From Baseline up to 10 weeks after Day of Embryo Transfer

  3. Number of Participants with an Ongoing Pregnancy

    Per study protocol, ongoing pregnancy is defined as confirmed pregnancy at 10 or more weeks ( ~ 70 days) after Day of Embryo Transfer, documented by a positive pregnancy test and ultrasound scan demonstrating at least one gestational sac with heart activity.

    Measured: Post treatment; at approximately 10 weeks from Day of Embryo Transfer

Timeline

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

  1. First posted16 May 2012 (estimated)
  2. Study startMar 2014
  3. Primary completionMay 2015 (estimated)
  4. Study completionJun 2015 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01599494
Sponsor's protocol ID
P07056
Other IDs
MK-8962-029
Status last verified
Feb 2022
First submitted
14 May 2012
Last updated
3 Feb 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MK-8962, recFSH and Ganirelix in people with Infertility, run by Organon and Co.

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 8 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: withdrawn, as of the sponsor's last update on 3 Feb 2022. 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 was withdrawn before enrolling participants, so there are no results.

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?

Number of Cumulus-Oocyte-Complexes Retrieved During Oocyte Pick-up (time frame: 34 to 36 hours after Day of Administration of Human Chorionic Gonadotropin (hCG)). 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 NCT01599494.

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 3 Feb 2022.

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