Complications; Artificial Fertilization, Introduction of Embryo in Embryo TransferPhase 2FUNDEX001NCT01298960
Growth Hormone (GH) in in Vitro Fertilization (IVF) Poor-responder Patients
A Phase 2 study testing Somatropin in people with Complications; Artificial Fertilization, Introduction of Embryo in Embryo Transfer, run by Fundacion Dexeus at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Complications; Artificial Fertilization, Introduction of Embryo in Embryo Transfer
- What is being tested?
- Somatropin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2011to Jun 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 9Show fewer
- Negative pregnancy test (serum or urine) before rFSH administration.
- Willingness of adhesion to protocol during the whole study period.
- Signed informed consent given.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus
Barcelona, 08037
About this study
Official title: 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.
- Being tested
- Somatropin
- Keywords
- Poor Ovarian response in IVF, Metaphase II oocytes, Pregnancy Rate, Growth Hormone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomatropinDrug
0.1 IU/Kg/day from day one of stimulation until rHCG triggering
| Study group | Role | What they receive |
|---|---|---|
| rGH Group | Experimental | Not described Receives: Drug: Somatropin |
| Non rGH group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of metaphase II oocytes retrieved
Measured: 3 months after having finished recruitment
Secondary outcomes (2)
Pregnancy rate
Measured: 9 months after ovum pick-up
Adverse events due to rGH
Measured: 3 months after having finished recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Complications; Artificial Fertilization, Introduction of Embryo in Embryo TransferStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Dexeus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignacio Rodriguez MSc, Fundacion Dexeus
- Investigators
- Pedro N Barri, PhD, MD, Study chair, Department of Obstetrics, Gyneacology and Reproductive Medicine, Institut Universitari DexeusBuenaventura Coroleu, PhD. MD, Principal investigator, Departament of Obstetrics, Gyneacology and Reproductive Medine, Institut Universitari DexeusMarta Devesa, MD, Principal investigator, Department of Obstetrics, Gyneacology and Reproductive Medicine, Institut Universitari DexeusFrancisca Martinez, PhD. MD, Principal investigator, Department of Obstetrics, Gyneacology and Reproductive Medicine, Institut Universitari Dexeus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298960
- Sponsor's protocol ID
- FUNDEX001
- Other IDs
- 2010-022151-32
- Acronym
- FUNDEX001
- Status last verified
- Feb 2020
- First submitted
- 17 Feb 2011
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Harper K, Proctor M, Hughes E. Growth hormone for in vitro fertilization. Cochrane Database Syst Rev. 2003;(3):CD000099. doi: 10.1002/14651858.CD000099.
PubMed 12917883Kolibianakis 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.
PubMed 19561136
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Randomized Study of Cotreatment With Growth Hormone in a Long GnRH Agonist Protocol in Women With Previous Poor Ovarian Response
- ClinicalTrials.gov ID
- NCT01298960
- Acronym / sponsor ID
- FUNDEX001 / FUNDEX001
- Keywords
- Poor Ovarian response in IVF, Metaphase II oocytes, Pregnancy Rate, Growth Hormone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Fundacion DexeusUniversity, hospital or other
- Study start
- Feb 2011 (actual)
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rGH Group | Experimental | Drug: Somatropin |
| Non rGH group | No intervention | – |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Somatropin0.1 IU/Kg/day from day one of stimulation until rHCG triggering | Drug | rGH Group |
Primary outcome
Number of metaphase II oocytes retrieved
Time frame: 3 months after having finished recruitment
2 secondary outcomes
Pregnancy rate
Time frame: 9 months after ovum pick-up
Adverse events due to rGH
Time frame: 3 months after having finished recruitment
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Background: PubMed 12917883Harper K, Proctor M, Hughes E. Growth hormone for in vitro fertilization. Cochrane Database Syst Rev. 2003;(3):CD000099. doi: 10.1002/14651858.CD000099.
- Background: PubMed 19561136Kolibianakis 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.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro N Barri, PhD, MD study chair
Department of Obstetrics, Gyneacology and Reproductive Medicine, Institut Universitari Dexeus
Buenaventura Coroleu, PhD. MD principal investigator
Departament of Obstetrics, Gyneacology and Reproductive Medine, Institut Universitari Dexeus
Marta Devesa, MD principal investigator
Department of Obstetrics, Gyneacology and Reproductive Medicine, Institut Universitari Dexeus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Somatropin in people with Complications; Artificial Fertilization, Introduction of Embryo in Embryo Transfer, run by Fundacion Dexeus at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of metaphase II oocytes retrieved (time frame: 3 months after having finished recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01298960, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.