NCT01298960

Brief Summary

Experimental study to evaluate if rGH addition to a standard controlled ovarian stimulation treatment improves ovarian response in women with previous poor ovarian response.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

February 17, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 18, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

2.3 years

First QC Date

February 17, 2011

Last Update Submit

February 10, 2020

Conditions

Complications; Artificial Fertilization, Introduction of Embryo in Embryo Transfer

Keywords

Poor Ovarian response in IVFMetaphase II oocytesPregnancy RateGrowth Hormone

Outcome Measures

Primary Outcomes (1)

  • Number of metaphase II oocytes retrieved

    3 months after having finished recruitment

Secondary Outcomes (2)

  • Pregnancy rate

    9 months after ovum pick-up

  • Adverse events due to rGH

    3 months after having finished recruitment

Study Arms (2)

rGH Group

EXPERIMENTAL
Drug: Somatropin

Non rGH group

NO INTERVENTION

Interventions

SomatropinDRUG

0.1 IU/Kg/day from day one of stimulation until rHCG triggering

rGH Group

Eligibility Criteria

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

You may qualify if:

  • Women who desire pregnancy with regular spontaneous menstrual cycles of 25-30 days length.
  • Infertility requiring IVF with or without ICSI.
  • Antecedent of a failed previous IVF cycle with a GnRH long agonist protocol in which at least 3000 IU of FSH were used (cancellation due to poor ovarian response - \< 4 mature follicles - or less than 5 oocytes retrieved)and antral follicle count \< 5.
  • Partner sperm.
  • Presence of both ovaries and normal uterine cavity.
  • PAP smear within normality in previous 3 years.
  • Negative pregnancy test (serum or urine) before rFSH administration.
  • Willingness of adhesion to protocol during the whole study period.
  • Signed informed consent given.

You may not qualify if:

  • HIV, HCV, HBV positive serologies in women or partner.
  • Important systemic diseases that could interfere with gonadotrophin treatment (ovarian and hypothalamic tumors...).
  • BMI \> 32 kg/m2 or antecedent of diabetes mellitus.
  • Gonadotrophin treatment within the previous 30 days.
  • Availability of frozen embryos of previous IVF cycles .
  • Abnormal uterine bleeding.
  • Previous treatment with LH or LH effect drugs.
  • Polycystic ovaries, increased size ovaries or presence of ovarian cysts of unknown ethiology.
  • Contraindication for pregnancy.
  • Allergies to gonadotrophins or somatotropin.
  • History of drug or alcohol abuse in the previous 5 years.
  • Previous enrollment in this study or simultaneous participation in another study with drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus

Barcelona, 08037, Spain

Location

Related Publications (2)

  • Harper K, Proctor M, Hughes E. Growth hormone for in vitro fertilization. Cochrane Database Syst Rev. 2003;(3):CD000099. doi: 10.1002/14651858.CD000099.

    PMID: 12917883BACKGROUND

  • Kolibianakis EM, Venetis CA, Diedrich K, Tarlatzis BC, Griesinger G. Addition of growth hormone to gonadotrophins in ovarian stimulation of poor responders treated by in-vitro fertilization: a systematic review and meta-analysis. Hum Reprod Update. 2009 Nov-Dec;15(6):613-22. doi: 10.1093/humupd/dmp026. Epub 2009 Jun 26.

    PMID: 19561136BACKGROUND

Related Links

MeSH Terms

Interventions

Human Growth Hormone

Intervention Hierarchy (Ancestors)

Growth HormonePituitary Hormones, AnteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Pedro N Barri, PhD, MD

    Department of Obstetrics, Gyneacology and Reproductive Medicine, Institut Universitari Dexeus

    STUDY CHAIR

  • Buenaventura Coroleu, PhD. MD

    Departament of Obstetrics, Gyneacology and Reproductive Medine, Institut Universitari Dexeus

    PRINCIPAL INVESTIGATOR

  • Marta Devesa, MD

    Department of Obstetrics, Gyneacology and Reproductive Medicine, Institut Universitari Dexeus

    PRINCIPAL INVESTIGATOR

  • Francisca Martinez, PhD. MD

    Department of Obstetrics, Gyneacology and Reproductive Medicine, Institut Universitari Dexeus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
BSC

Study Record Dates

First Submitted

February 17, 2011

First Posted

February 18, 2011

Study Start

February 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

February 12, 2020

Record last verified: 2020-02

Locations

ES(1)