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InfertilityPhase 4PEM-ESDNCT02402192

Type of Gonadotropin and Embryo Kinetics of Development

A Phase 4 study testing Corifollitropin alfa in people with Infertility, run by IVI Madrid.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The study is proposed to determine the effect of three types of gonadotropins that are currently used in protocols of controlled ovarian stimulation in women undergoing in vitro fertilization techniques on the kinetics of embryonic development. Read more about this study

Who is it for?
Ages 18 to 37 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infertility
What is being tested?
Corifollitropin alfa
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
201 participants
Where
No sites listed yet
Study dates
Apr 2015to Dec 2016
Phase
Phase 4
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 37 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Women <38 years old
  • Weight <60 kg
  • Own oocytes
  • Patients have to provide signed informed consent

Who cannot join

  • Oocyte donors
  • Vitrified oocytes
  • Severe male factor (<1 million spz/ml)
  • Weight >60 kg

About this study

Official title: A Prospective Randomized Trial to Analyze the Effect of the Gonadotropin Administered During Control Ovarian Stimulation on Embryo Kinetics of Development

The study is proposed to determine the effect of three types of gonadotropins that are currently used in protocols of controlled ovarian stimulation in women undergoing in vitro fertilization techniques on the kinetics of embryonic development.

Conditions
Infertility
Being tested
Corifollitropin alfa
Keywords
corifollitropin alfa, recombinant FSH, HP-hMG, time-lapse, kinetics of development
Medical subject headings
Infertility

What participants receive

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

  • Corifollitropin alfaDrug

    Also called Elonva

Study groups in NCT02402192
Study groupRoleWhat they receive
Corifollitropin alfaActive comparatorUnder current practice, 67 participants will be stimulated with a single injection of 100 mg, sc of Corifollitropin alpha (Elonva®). From day 6 stimulation and even prior to induction of ovulation day, 0.25 mg / day was administered sc ganirelix (Orgalutran®). From day 8 stimulation and depending on the ovarian response, you can add recombinant FSH (Puregon) up to 150 IU by Puregon Pen® device. In the presence of 3 or more follicles ≥17 mm, ovulation is induced with a single dose of 0.2 mg Decapeptyl 6500u or hCG (Ovitrelle) if there is no risk of OHSS, and 36 hours later he held the follicular puncture oocyte retrieval.
Receives: Drug: Corifollitropin alfa
recombinant FSHActive comparatorUnder current practice, 67 participants will be stimulated with a daily dose of recombinant FSH. Administration of recombinant FSH (Puregon) starts at an initial dose of 150-225 IU / day by the Puregon Pen® device. From day 6 stimulation 0.25 mg / day administered sc ganirelix (Orgalutran®). From this day may also vary the dose of recombinant FSH according ovarian response. In the presence of 3 or more follicles ≥17 mm, a single dose of 0.2 mg or Decapeptyl hCG 6500u (Ovitrelle) is given if there is no risk of OHSS, and 36 hours then held follicular puncture for recovering oocytes.
Receives: Drug: Corifollitropin alfa
HP- hMGActive comparatorUnder current practice, 67 participants will be stimulated with HP-hMG, following the same pattern described for the group of recombinant FSH. In this case, the initial dose is 225-300 IU / day of HP-hMG (Menopur®). From day 6 stimulation 0.25 mg / day administered sc ganirelix (Orgalutran®). From this day may also vary the dose of HP-hMG according ovarian response. In the presence of 3 or more follicles ≥17 mm, a single dose of 0.2 mg Decapeptyl 6500u or hCG (Ovitrelle) is given if there is no risk of OHSS and 36 hours then held the follicular puncture for oocyte retrieval .
Receives: Drug: Corifollitropin alfa

What is being measured

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

  1. T5 defined as the time that embryo needs to reach a 5-cell stage.

    Measured: Baseline

Secondary outcomes (13)

  1. Length of stimulation (days)

    Measured: a month

  2. Total dose of gonadotropins (IU)

    Measured: A month

  3. Levels of FSH (IU) Levels of estradiol (pg / ml) - Levels of progesterone (ng / ml) - Fertilization rate - Number of embryos transferred and cryopreserved - Pregnancy rate - Implantation

    Measured: A month

  4. Levels of estradiol (pg / ml) Number of embryos transferred and cryopreserved - Pregnancy rate - Implantation

    Measured: A month

  5. Levels of progesterone (ng/ml)

    Measured: A month

  6. Fertilization rate

    Measured: A month

  7. Number of embryos transferred and cryopreserved

    Measured: A month

  8. Pregnancy rate

    Measured: A month

  9. Implantation rate

    Measured: A monthe

  10. Miscarriage rate

    Measured: A month

  11. Cancellation rate per cycle initiated

    Measured: A month

  12. Ovarian hyperstimulation syndrome rate

    Measured: A month

  13. Timings of cellular divisions

    Measured: A month

Timeline

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

  1. First posted30 Mar 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionSep 2015
  4. Study completionDec 2016

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
None (open label)
Enrolment
201 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02402192
Sponsor's protocol ID
1411-MAD-079-CB
Acronym
PEM-ESD
Status last verified
Aug 2022
First submitted
18 Mar 2015
Last updated
11 Aug 2022
Results posted
No
Data monitoring committee
No

Publications

  • Meseguer M, Rubio I, Cruz M, Basile N, Marcos J, Requena A. Embryo incubation and selection in a time-lapse monitoring system improves pregnancy outcome compared with a standard incubator: a retrospective cohort study. Fertil Steril. 2012 Dec;98(6):1481-9.e10. doi: 10.1016/j.fertnstert.2012.08.016. Epub 2012 Sep 10.

    PubMed 22975113

  • Devroey P, Boostanfar R, Koper NP, Mannaerts BM, Ijzerman-Boon PC, Fauser BC; ENGAGE Investigators. A double-blind, non-inferiority RCT comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol. Hum Reprod. 2009 Dec;24(12):3063-72. doi: 10.1093/humrep/dep291. Epub 2009 Aug 14.

    PubMed 19684043

  • Garcia-Velasco JA, Zuniga A, Pacheco A, Gomez R, Simon C, Remohi J, Pellicer A. Coasting acts through downregulation of VEGF gene expression and protein secretion. Hum Reprod. 2004 Jul;19(7):1530-8. doi: 10.1093/humrep/deh298. Epub 2004 May 20.

    PubMed 15155606

  • Requena A, Cruz M, Collado D, Izquierdo A, Ballesteros A, Munoz M, Garcia-Velasco JA. Evaluation of the degree of satisfaction in oocyte donors using sustained-release FSH corifollitropin alpha. Reprod Biomed Online. 2013 Mar;26(3):253-9. doi: 10.1016/j.rbmo.2012.11.015. Epub 2012 Dec 5.

    PubMed 23352098

  • Seyhan A, Ata B. The role of corifollitropin alfa in controlled ovarian stimulation for IVF in combination with GnRH antagonist. Int J Womens Health. 2011;3:243-55. doi: 10.2147/IJWH.S15002. Epub 2011 Aug 8.

    PubMed 21892335

  • Meseguer M, Herrero J, Tejera A, Hilligsoe KM, Ramsing NB, Remohi J. The use of morphokinetics as a predictor of embryo implantation. Hum Reprod. 2011 Oct;26(10):2658-71. doi: 10.1093/humrep/der256. Epub 2011 Aug 9.

    PubMed 21828117

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Corifollitropin alfa in people with Infertility, run by IVI Madrid.

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 4 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: stopped early, as of the sponsor's last update on 11 Aug 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 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?

The study was stopped early. Results are not available in the source record.

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?

T5 defined as the time that embryo needs to reach a 5-cell stage. (time frame: Baseline). 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 NCT02402192, which also lists 6 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 11 Aug 2022.

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