NCT01816321

Brief Summary

In combination with the existing literature, previous work indicates that 1) women with poor ovarian response fulfilling the "Bologna criteria" have very low pregnancy rates, irrespective of age 2) current treatment protocols demonstrate ongoing pregnancy rates that do not exceed 8.5% and 3) corifollitropin alfa followed by hpHMG might increase ongoing pregnancy rates in young patients (\<40years old) fulfilling the criteria. These findings provide a strong rationale for a definitive large RCT. The COMPORT study will provide conclusive evidence regarding the superiority or not of this novel protocol with corifollitropin alfa followed by hpHMG for the treatment of young poor ovarian responders fulfilling the Bologna criteria.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2013

Typical duration for phase_3

Geographic Reach
2 countries

2 active sites

Status
completed

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

Study Start

First participant enrolled

March 1, 2013

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 22, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 23, 2016

Status Verified

June 1, 2016

Enrollment Period

3.2 years

First QC Date

March 16, 2013

Last Update Submit

June 21, 2016

Conditions

InfertilityPoor Ovarian Response

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy

    The presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity at 9-10 weeks of gestation.

    9-10 weeks of gestation

Secondary Outcomes (3)

  • Clinical pregnancy

    7 weeks of gestation

  • Biochemical pregnancy

    2 weeks after embryo transfer

  • Number of oocytes retrieved

    9 -20 days from initiation of ovarian stimulation

Other Outcomes (6)

  • Cycle cancellation due to poor ovarian response

    Day 8-10 of ovarian stimulation

  • Number of cycles reaching the stage of embryo transfer

    9 -20 days from initiation of ovarian stimulation

  • Number and quality of embryos

    Day of embryo transfer

  • +3 more other outcomes

Study Arms (2)

Corifollitropin alfa followed by hpHMG

EXPERIMENTAL
Drug: Corifollitropin alfaDrug: GanirelixDrug: hp HMG

recombinant FSH

ACTIVE COMPARATOR
Drug: recombinant FSHDrug: Ganirelix

Interventions

Corifollitropin alfaDRUG

Corifollitropin alfa 150μg on day 2 of the menstrual cycle (stimulation day 1)

Corifollitropin alfa followed by hpHMG
recombinant FSHDRUG

recombinant FSH 300IU/daily from day 2 of the cycle (stimulation day 8)until day of ovulation triggering

recombinant FSH
GanirelixDRUG

Ganirelix 0.25mg/daily from day 7 of the cycle(stimulation day 6) until day of ovulation triggering

Corifollitropin alfa followed by hpHMGrecombinant FSH
hp HMGDRUG

hp HMG 300IU/daily from day 9 of the cycle (stimulation day 8)until day of ovulation triggering

Corifollitropin alfa followed by hpHMG

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age less than 40 years
  • Fulfillment of the "Bologna criteria" for poor ovarian response.
  • Women \< 40 years old AND ≤3 oocytes in one of the previous cycles AND (Antral follicle count \<7 or antimullerian hormone serum values \<1.1 ng/ml)
  • Women \<40 years old and ≤3 oocytes in two the previous cycles with maximum ovarian stimulation
  • In addition women less than 40 years old will be considered eligible if they had undergone previous ovarian surgery or chemotherapy (risk factors for poor ovarian response) and have an AMH\<1.1ng/ml or an AFC\<7, as suggested by the Bologna criteria

You may not qualify if:

  • Uterine abnormalities
  • Recent history of any current untreated endocrine abnormality
  • Unilateral or bilateral hydrosalpinx (visible on transvaginal ultrasound, unless clipped)
  • Contraindications for the use of gonadotropins
  • Recent history of severe disease requiring regular treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

Location

University of Medicine and Pharmacy of Ho Chi Minh City

Ho Chi Minh City, Vietnam

Location

Related Publications (6)

  • Polyzos NP, De Vos M, Corona R, Vloeberghs V, Ortega-Hrepich C, Stoop D, Tournaye H. Addition of highly purified HMG after corifollitropin alfa in antagonist-treated poor ovarian responders: a pilot study. Hum Reprod. 2013 May;28(5):1254-60. doi: 10.1093/humrep/det045. Epub 2013 Feb 26.

    PMID: 23442756BACKGROUND

  • Polyzos NP, Devos M, Humaidan P, Stoop D, Ortega-Hrepich C, Devroey P, Tournaye H. Corifollitropin alfa followed by rFSH in a GnRH antagonist protocol for poor ovarian responder patients: an observational pilot study. Fertil Steril. 2013 Feb;99(2):422-6. doi: 10.1016/j.fertnstert.2012.09.043. Epub 2012 Oct 16.

    PMID: 23084565BACKGROUND

  • Polyzos NP, Blockeel C, Verpoest W, De Vos M, Stoop D, Vloeberghs V, Camus M, Devroey P, Tournaye H. Live birth rates following natural cycle IVF in women with poor ovarian response according to the Bologna criteria. Hum Reprod. 2012 Dec;27(12):3481-6. doi: 10.1093/humrep/des318. Epub 2012 Aug 30.

    PMID: 22940767BACKGROUND

  • Polyzos NP, Devroey P. A systematic review of randomized trials for the treatment of poor ovarian responders: is there any light at the end of the tunnel? Fertil Steril. 2011 Nov;96(5):1058-61.e7. doi: 10.1016/j.fertnstert.2011.09.048.

    PMID: 22036048BACKGROUND

  • Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19.

    PMID: 21505041BACKGROUND

  • Drakopoulos P, Vuong TNL, Ho NAV, Vaiarelli A, Ho MT, Blockeel C, Camus M, Lam AT, van de Vijver A, Humaidan P, Tournaye H, Polyzos NP. Corifollitropin alfa followed by highly purified HMG versus recombinant FSH in young poor ovarian responders: a multicentre randomized controlled clinical trial. Hum Reprod. 2017 Nov 1;32(11):2225-2233. doi: 10.1093/humrep/dex296.

    PMID: 29040589DERIVED

MeSH Terms

Conditions

Infertility

Interventions

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

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Nikolaos P Polyzos, MD PhD

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 16, 2013

First Posted

March 22, 2013

Study Start

March 1, 2013

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

June 23, 2016

Record last verified: 2016-06

Locations

BE(1)VN(1)