InfertilityPhase 4NCT01715324
Adjuvant Growth Therapy in in Vitro Fertilization
A Phase 4 study testing Adjuvant Growth Hormon in people with Infertility, run by Clinique Ovo at 1 site in Canada.
Trial summary
In an In Vitro Fertilization (IVF) cycle super ovulating drugs (gonadotropins) are usually taken to stimulate the ovaries to produce more than one egg. In Vitro Fertilization protocols are constantly under review in order to improve the recruitment of the follicles, which contain the eggs, whilst minimizing the doses… Read more about this study
- Who is it for?
- Ages 35 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Adjuvant Growth Hormon
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteCanada
- Study dates
- 25 Jun 2014to Aug 2021
- Phase
- Phase 4
- 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 35 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women between the ages of 35 to 42
- Primary or secondary infertility)
- No previous treatment IVF cycle using the same proposed protocol
- Negative pregnancy test at randomization (urine or blood)
Who cannot join
- Contraindication to Saizen®
- Simultaneous participation in another clinical trial
- follicle stimulating hormone > 12 IU/L and/or anti-mullerian hormone < 0.5 pg/ml
- Body mass index ≥ 35 kg/m2
- Known risk of gestational diabetes
- Administration of any investigational medication three months prior to study enrolment
- Positive results of screening for either partner for HIV antibodies, Hepatitis B (other than surface antibodies present after vaccination) or Hepatitis C
- Not able to communicate in French or English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjuvant Growth Therapy in in Vitro Fertilization: A Randomized Control Trial
In an In Vitro Fertilization (IVF) cycle super ovulating drugs (gonadotropins) are usually taken to stimulate the ovaries to produce more than one egg. In Vitro Fertilization protocols are constantly under review in order to improve the recruitment of the follicles, which contain the eggs, whilst minimizing the doses of gonadotrophins required, with the ultimate aim of increasing the live birth rate.
Read the detailed description
The addition of growth hormone, which is a biological hormone that can be synthetically produced, as a supplement to gonadotrophins in an In Vitro Fertilization cycle has been suggested as a way in which In Vitro Fertilization pregnancy rates may be increased.Growth hormone has been shown, in animal and human studies, to be important in the recruitment of follicles.However, to date, only a limited number of clinical studies have been performed in order to assess whether the addition of growth hormone can improve the probability of pregnancy in women undergoing ovarian stimulation for In Vitro Fertilization. As the total number of patients analysed in these studies was small it has not been possible to determine whether if there is any improvement the outcome of an In Vitro Fertilization cycle when a woman is given growth hormone therapy as a supplement during her treatment.
This goal of this study is to determine the effectiveness of using growth hormone therapy as a supplement to the administration of gonadotropins in an antagonist In Vitro Fertilization protocol.
- Conditions
- Infertility
- Being tested
- Adjuvant Growth Hormon
- Keywords
- In vitro fertilization, Antagonist protocol, Growth Hormone
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adjuvant Growth HormonDrug
Also called Saizen
The treatment group will receive 2.5 mg of Saizen daily via subcutaneous injections, from the beginning of the ovarian reserve stimulation until the day of the ovulation triggering
| Study group | Role | What they receive |
|---|---|---|
| Growth Hormon | Experimental | The participants randomized in the control group will be prescribed a regular antagonist IVF cycle with dose appropriate stimulation medication and will receive 2.5 mg of Adjuvant Growth Hormon (Saizen) daily via subcutaneous injections, from the beginning of the ovarian reserve stimulation until the day of the ovulation triggering. Receives: Drug: Adjuvant Growth Hormon |
| Control | No intervention | The participants randomized in the control group will be prescribed a regular antagonist IVF cycle with dose appropriate stimulation medication without Adjuvant Growth Hormon (Saizen). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
To determine if the clinical pregnancy rate during the course of one treatment cycle in women receiving Growth Hormone daily in addition to gonadotropin-releasing hormone antagonist protocol is significantly higher than those receiving only gonadotropin-releasing hormone antagonist protocol (control group).
Measured: 7 weeks
Secondary outcomes (13)
Total dose of gonadotropins
To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
Measured: 7 weeks
Number of observed follicles
To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
Measured: 7 weeks
Number of mature (Metaphase II) oocytes retrieved
To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
Measured: 7 weeks
Oocyte morphology
To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
Measured: 7 weeks
Fertilization rate
To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
Measured: 7 weeks
Embryo morphology
To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
Measured: 7 weeks
Embryo cleavage rate
To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
Measured: 7 weeks
Number of embryos available
To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
Measured: 7 weeks
Number of supernumerary embryos available for cryopreservation
To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
Measured: 7 weeks
Implantation rate
To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
Measured: 7 weeks
Miscarriage rate
To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
Measured: 40 weeks
Live birth rate
To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
Measured: 40 weeks
Adverse side effects in women
To evaluate the effectiveness of Growth Hormon adjuvant therapy in gonadotropin-releasing hormone antagonist protocol when compared to the control group.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study start25 Jun 2014
- Primary completionJul 2021
- Study completionAug 2021
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 InfertilityStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Ovo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EMD Serono
- Responsible party
- Sponsor
- Investigators
- Jacques Kadoch, MD, Principal investigator, Clinique Ovo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715324
- Sponsor's protocol ID
- OVO-09-03
- Status last verified
- Jan 2022
- First submitted
- 24 Oct 2012
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mourad A, Jamal W, Hemmings R, Tadevosyan A, Phillips S, Kadoch IJ. Empirical use of growth hormone in IVF is useless: the largest randomized controlled trial. Hum Reprod. 2025 Jan 1;40(1):77-84. doi: 10.1093/humrep/deae251.
PubMed 39673334Sood A, Mohiyiddeen G, Ahmad G, Fitzgerald C, Watson A, Mohiyiddeen L. Growth hormone for in vitro fertilisation (IVF). Cochrane Database Syst Rev. 2021 Nov 22;11(11):CD000099. doi: 10.1002/14651858.CD000099.pub4.
PubMed 34808697
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Growth Therapy in in Vitro Fertilization: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT01715324
- Acronym / sponsor ID
- OVO-09-03
- Conditions
- Infertility
- Keywords
- In vitro fertilization, Antagonist protocol, Growth Hormone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Clinique OvoIndustry (pharma, biotech, devices)
- Collaborators
- EMD Serono
- Study start
- 25 Jun 2014 (actual)
- Primary completion
- Jul 2021 (actual)
- Study completion
- Aug 2021 (actual)
- First posted
- 26 Oct 2012 (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.
In an In Vitro Fertilization (IVF) cycle super ovulating drugs (gonadotropins) are usually taken to stimulate the ovaries to produce more than one egg. In Vitro Fertilization protocols are constantly under review in order to improve the recruitment of the follicles, which contain the eggs, whilst minimizing the doses of gonadotrophins required, with the ultimate aim of increasing the live birth rate.
Detailed description
The addition of growth hormone, which is a biological hormone that can be synthetically produced, as a supplement to gonadotrophins in an In Vitro Fertilization cycle has been suggested as a way in which In Vitro Fertilization pregnancy rates may be increased.Growth hormone has been shown, in animal and human studies, to be important in the recruitment of follicles.However, to date, only a limited number of clinical studies have been performed in order to assess whether the addition of growth hormone can improve the probability of pregnancy in women undergoing ovarian stimulation for In Vitro Fertilization. As the total number of patients analysed in these studies was small it has not been possible to determine whether if there is any improvement the outcome of an In Vitro Fertilization cycle when a woman is given growth hormone therapy as a supplement during her treatment.
This goal of this study is to determine the effectiveness of using growth hormone therapy as a supplement to the administration of gonadotropins in an antagonist In Vitro Fertilization protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Growth Hormon | Experimental | Drug: Adjuvant Growth HormonThe participants randomized in the control group will be prescribed a regular antagonist IVF cycle with dose appropriate stimulation medication and will receive 2.5 mg of Adjuvant Growth Hormon (Saizen) daily via subcutaneous injections, from the beginning of the ovarian reserve stimulation until the day of the ovulation triggering. |
| Control | No intervention | –The participants randomized in the control group will be prescribed a regular antagonist IVF cycle with dose appropriate stimulation medication without Adjuvant Growth Hormon (Saizen). |
Who may qualify
- Ages
- 35 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women between the ages of 35 to 42
- Primary or secondary infertility)
- Negative pregnancy test at randomization (urine or blood)
Key exclusion criteria (8 listed)
- Contraindication to Saizen®
- Simultaneous participation in another clinical trial
- follicle stimulating hormone > 12 IU/L and/or anti-mullerian hormone < 0.5 pg/ml
- Body mass index ≥ 35 kg/m2
- Known risk of gestational diabetes
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 |
|---|---|---|
| Adjuvant Growth HormonAlso: SaizenThe treatment group will receive 2.5 mg of Saizen daily via subcutaneous injections, from the beginning of the ovarian reserve stimulation until the day of the ovulation triggering | Drug | Growth Hormon |
Primary outcome
Clinical pregnancy rate
Time frame: 7 weeks
To determine if the clinical pregnancy rate during the course of one treatment cycle in women receiving Growth Hormone daily in addition to gonadotropin-releasing hormone antagonist protocol is significantly higher than those receiving only gonadotropin-releasing hormone antagonist protocol (control group).
13 secondary outcomes
Total dose of gonadotropins
Time frame: 7 weeks
Number of observed follicles
Time frame: 7 weeks
Number of mature (Metaphase II) oocytes retrieved
Time frame: 7 weeks
Oocyte morphology
Time frame: 7 weeks
Fertilization rate
Time frame: 7 weeks
Embryo morphology
Time frame: 7 weeks
Embryo cleavage rate
Time frame: 7 weeks
Number of embryos available
Time frame: 7 weeks
Number of supernumerary embryos available for cryopreservation
Time frame: 7 weeks
Implantation rate
Time frame: 7 weeks
Miscarriage rate
Time frame: 40 weeks
Live birth rate
Time frame: 40 weeks
Adverse side effects in women
Time frame: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Derived from this study: PubMed 39673334Mourad A, Jamal W, Hemmings R, Tadevosyan A, Phillips S, Kadoch IJ. Empirical use of growth hormone in IVF is useless: the largest randomized controlled trial. Hum Reprod. 2025 Jan 1;40(1):77-84. doi: 10.1093/humrep/deae251.
- Derived from this study: PubMed 34808697Sood A, Mohiyiddeen G, Ahmad G, Fitzgerald C, Watson A, Mohiyiddeen L. Growth hormone for in vitro fertilisation (IVF). Cochrane Database Syst Rev. 2021 Nov 22;11(11):CD000099. doi: 10.1002/14651858.CD000099.pub4.
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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.
Jacques Kadoch, MD principal investigator
Clinique Ovo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adjuvant Growth Hormon in people with Infertility, run by Clinique Ovo at 1 site in Canada.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 11 Jan 2022. 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 Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical pregnancy rate (time frame: 7 weeks). 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 NCT01715324, 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 11 Jan 2022.