NCT02402192

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2015

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 11, 2022

Status Verified

August 1, 2022

Enrollment Period

5 months

First QC Date

March 18, 2015

Last Update Submit

August 9, 2022

Conditions

Infertility

Keywords

corifollitropin alfarecombinant FSHHP-hMGtime-lapsekinetics of development

Outcome Measures

Primary Outcomes (1)

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

    Baseline

Secondary Outcomes (13)

  • Length of stimulation (days)

    a month

  • Total dose of gonadotropins (IU)

    A month

  • 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

    A month

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

    A month

  • Levels of progesterone (ng/ml)

    A month

  • +8 more secondary outcomes

Study Arms (3)

Corifollitropin alfa

ACTIVE COMPARATOR

Under 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.

Drug: Corifollitropin alfa

recombinant FSH

ACTIVE COMPARATOR

Under 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.

Drug: Corifollitropin alfa

HP- hMG

ACTIVE COMPARATOR

Under 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 .

Drug: Corifollitropin alfa

Interventions

Corifollitropin alfaDRUG
Also known as: Elonva
Corifollitropin alfaHP- hMGrecombinant FSH

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 22975113BACKGROUND

  • 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.

    PMID: 19684043RESULT

  • 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.

    PMID: 15155606RESULT

  • 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.

    PMID: 23352098RESULT

  • 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.

    PMID: 21892335RESULT

  • 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.

    PMID: 21828117RESULT

MeSH Terms

Conditions

Infertility

Interventions

follicle stimulating hormone, human, with HCG C-terminal peptide

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD MD

Study Record Dates

First Submitted

March 18, 2015

First Posted

March 30, 2015

Study Start

April 1, 2015

Primary Completion

September 1, 2015

Study Completion

December 1, 2016

Last Updated

August 11, 2022

Record last verified: 2022-08