Growth Hormone (GH) in in Vitro Fertilization (IVF) Poor-responder Patients (FUNDEX001)

February 10, 2020 updated by: Ignacio Rodriguez MSc, Institut Universitari Dexeus

Phase II Randomized Study of Cotreatment With Growth Hormone in a Long GnRH Agonist Protocol in Women With Previous Poor Ovarian Response

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08037
        • Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rGH Group
Drug: Somatropin
0.1 IU/Kg/day from day one of stimulation until rHCG triggering
No Intervention: Non rGH group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of metaphase II oocytes retrieved
Time Frame: 3 months after having finished recruitment
3 months after having finished recruitment

Secondary Outcome Measures

Outcome Measure
Time Frame
Pregnancy rate
Time Frame: 9 months after ovum pick-up
9 months after ovum pick-up
Adverse events due to rGH
Time Frame: 3 months after having finished recruitment
3 months after having finished recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Universitari Dexeus

Investigators

  • Study Chair: Pedro N Barri, PhD, MD, Department of Obstetrics, Gyneacology and Reproductive Medicine, Institut Universitari Dexeus
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

February 17, 2011

First Submitted That Met QC Criteria

February 17, 2011

First Posted (Estimate)

February 18, 2011

Study Record Updates

Last Update Posted (Actual)

February 12, 2020

Last Update Submitted That Met QC Criteria

February 10, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FUNDEX001
  • 2010-022151-32 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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