NCT02244866

Brief Summary

To compare the efficacy between LH supplementation (Pergoveris) and non-LH supplementation (Follitropin alpha) in patients aged ≥ 35 years undergoing IVF treatment. Study hypothesis: Pergoveris (LH supplementation) is better than follitropin alpha (non-LH supplementation) for ovarian stimulation in aged IVF patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

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

October 1, 2012

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
Last Updated

December 25, 2014

Status Verified

December 1, 2014

Enrollment Period

1.5 years

First QC Date

September 16, 2014

Last Update Submit

December 23, 2014

Conditions

Infertility

Keywords

IVFLH supplementationovarian stimulationpoor responder

Outcome Measures

Primary Outcomes (2)

  • Clinical pregnancy

    Clinical pregnancy is defined by the image gestational sac under ultrasonography.

    7 weeks after embryo transfer

  • Live birth

    Live birth is defined if a live newborn delivered.

    at the time of delivery

Secondary Outcomes (1)

  • Total FSH international units (IU) used for stimulation

    Measure at the time when stimulation finishes, eg. in average 10-11 days, maximum 20 days

Study Arms (2)

Pergoveris (FSH and LH)

ACTIVE COMPARATOR

150 IU of recombinant FSH and 75 IU of recombinant LH (Pergoveris) daily subcutaneous injection

Drug: Pergoveris (FSH and LH)

Follitropin alpha (FSH)

ACTIVE COMPARATOR

150 IU of recombinant FSH (follitropin alpha or Gonal-F) daily subcutaneous injection

Drug: Follitropin alpha (FSH)

Interventions

Pergoveris (FSH and LH)DRUG

Drugs are injected subcutaneously everyday until ovarian follicles reach 17mm in diameter.

Also known as: Pergoveris
Pergoveris (FSH and LH)
Follitropin alpha (FSH)DRUG

Drugs are injected subcutaneously everyday until ovarian follicles reach 17mm in diameter.

Also known as: Gonal-F
Follitropin alpha (FSH)

Eligibility Criteria

Age35 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age ≥ 35 years
  • body mass index \<28 kg/m2
  • had ≤ 3 previous IVF attempts
  • receiving a GnRH-antagonist protocol
  • agreement to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.
  • have given written informed consent with the understanding that the subject may withdraw consent at any time

You may not qualify if:

  • participating in another interventional clinical trial
  • PCOS or WHO group 1
  • have uterine abnormalities
  • have endocrine disorders such as hyperprolactinemia, thyroid disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

An Sinh Hospital

Ho Chi Minh City, Vietnam

Location

Related Publications (1)

  • Vuong TN, Phung HT, Ho MT. Recombinant follicle-stimulating hormone and recombinant luteinizing hormone versus recombinant follicle-stimulating hormone alone during GnRH antagonist ovarian stimulation in patients aged >/=35 years: a randomized controlled trial. Hum Reprod. 2015 May;30(5):1188-95. doi: 10.1093/humrep/dev038. Epub 2015 Mar 3.

    PMID: 25740882DERIVED

MeSH Terms

Conditions

Infertility

Interventions

pergoverisGlycoprotein Hormones, alpha Subunitfollitropin alfa

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Chorionic GonadotropinGonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsFollicle Stimulating HormoneGonadotropins, PituitaryLuteinizing HormonePituitary Hormones, AnteriorPituitary HormonesThyrotropinPlacental HormonesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Tuong M Ho, MD

    CGRH, School of Medicine, Vietnam National University HCMC, Vietnam

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 16, 2014

First Posted

September 19, 2014

Study Start

October 1, 2012

Primary Completion

April 1, 2014

Study Completion

June 1, 2014

Last Updated

December 25, 2014

Record last verified: 2014-12

Locations

VN(1)