InfertilityPhase 4NCT00415766
Comparison Between Recombinant Versus Urinary hCG for Ovulation Induction in High Responders
A Phase 4 study testing rHCG 250ug, uHCG 5000 IU and uHCG 7500 IU in people with Infertility, run by Eugonia at 1 site in Greece.
Trial summary
The purpose of this study is to compare the clinical outcomes of recombinant human chorionic gonadotrophin (rHCG) and urinary HCG (uHCG) in patients undergoing IVF cycles. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- rHCG 250ug, uHCG 5000 IU and uHCG 7500 IU
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGreece
- Study dates
- Jun 2013to Jul 2016
- 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 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- At least 14 follicles >11mm on the day of triggering final oocyte maturation
- Pretreated with GnRH antagonist protocol
Who cannot join
- Poor responders
- Women with 25 or more follicles on the day of trigger
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Recombinant hCG (Ovitrelle) Vesrus Urinary hCG (Pregnyl) for Triggering Final Oocyte Maturation in High Responders
The purpose of this study is to compare the clinical outcomes of recombinant human chorionic gonadotrophin (rHCG) and urinary HCG (uHCG) in patients undergoing IVF cycles.
Read the detailed description
Urinary human chorionic gonadotrophin (u-hCG) has been widely used to induce final oocyte maturation and to trigger ovulation in assisted conception. Recombinant technology has allowed the production of r-hCG inj which all urinary contaminants are absent. Hence, this would allow the safe subcutaneous administration of a compound with less batch-to-batch variation. This study will investigate the effectiveness of the recombinant hCG compared to the currently used urinary hCG.
- Conditions
- Infertility
- Being tested
- rHCG 250ug, uHCG 5000 IU, uHCG 7500 IU
- Keywords
- recombinant hCG, urinary hCG
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rHCG 250ugDrug
Also called Ovitrelle
Injection of 250 ug Ovitrelle to trigger final oocyte maturation
uHCG 5000 IUDrug
Also called Pregnyl 5000 IU
Injection of 5000 IU Pregnyl to trigger final oocyte maturation
uHCG 7500 IUDrug
Also called Pregnyl 7500 IU
Injection of 7500 IU Pregnyl to trigger final oocyte maturation
| Study group | Role | What they receive |
|---|---|---|
| rHCG 250 ug | Active comparator | Injection of 250 ug Ovitrelle to trigger final oocyte maturation Receives: Drug: rHCG 250ug |
| uHCG 5000 IU | Active comparator | Injection of 5000 IU Pregnyl to trigger final oocyte maturation Receives: Drug: uHCG 5000 IU |
| uHCG 7500 IU | Active comparator | Injection of 7500 IU Pregnyl to trigger final oocyte maturation Receives: Drug: uHCG 7500 IU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of mature oocytes
Percentage MII/COCs
Measured: Day of oocyte retrieval (Day 0)
Secondary outcomes (8)
Positive test per embryo transfer
Measured: 15 days post oocyte retrieval
Clinical pregnancy per embryo transfer
Measured: 7 weeks of gestation
Ongoing pregnancy per embryo transfer
Measured: 12 weeks of gestation
Level of serum hCG on day of oocyte retrieval
Measured: Day of oocyte retrieval
Number of oocytes (COC) retrieved
Measured: Day of oocyte retrieval
Number of mature oocytes (MII)
Measured: Day of oocyte retrieval
Oocyte retrieval rate
Number of oocytes retrieved/number of follicles on the day of triggering final oocyte maturation
Measured: Day of oocyte retrieval (Day 0)
Incidence of severe early OHSS
Measured: up to Day 5 post oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2006 (estimated)
- Study startJun 2013
- Primary completionDec 2015
- Study completionJul 2016 (estimated)
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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eugonia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tryfon Lainas, PhD, Principal investigator, Eugonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00415766
- Sponsor's protocol ID
- ovitrelle vs pregnyl
- Status last verified
- Jan 2016
- First submitted
- 22 Dec 2006
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Revelli A, Poso F, Gennarelli G, Moffa F, Grassi G, Massobrio M. Recombinant versus highly-purified, urinary follicle-stimulating hormone (r-FSH vs. HP-uFSH) in ovulation induction: a prospective, randomized study with cost-minimization analysis. Reprod Biol Endocrinol. 2006 Jul 18;4:38. doi: 10.1186/1477-7827-4-38.
PubMed 16848893Al-Inany HG, Aboulghar M, Mansour R, Proctor M. Recombinant versus urinary human chorionic gonadotrophin for ovulation induction in assisted conception. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003719. doi: 10.1002/14651858.CD003719.pub2.
PubMed 15846677
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant hCG (Ovitrelle) Vesrus Urinary hCG (Pregnyl) for Triggering Final Oocyte Maturation in High Responders
- ClinicalTrials.gov ID
- NCT00415766
- Acronym / sponsor ID
- ovitrelle vs pregnyl
- Conditions
- Infertility
- Keywords
- recombinant hCG, urinary hCG
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- EugoniaUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jul 2016 (estimated)
- First posted
- 25 Dec 2006 (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.
The purpose of this study is to compare the clinical outcomes of recombinant human chorionic gonadotrophin (rHCG) and urinary HCG (uHCG) in patients undergoing IVF cycles.
Detailed description
Urinary human chorionic gonadotrophin (u-hCG) has been widely used to induce final oocyte maturation and to trigger ovulation in assisted conception. Recombinant technology has allowed the production of r-hCG inj which all urinary contaminants are absent. Hence, this would allow the safe subcutaneous administration of a compound with less batch-to-batch variation. This study will investigate the effectiveness of the recombinant hCG compared to the currently used urinary hCG.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| rHCG 250 ug | Active comparator | Drug: rHCG 250ugInjection of 250 ug Ovitrelle to trigger final oocyte maturation |
| uHCG 5000 IU | Active comparator | Drug: uHCG 5000 IUInjection of 5000 IU Pregnyl to trigger final oocyte maturation |
| uHCG 7500 IU | Active comparator | Drug: uHCG 7500 IUInjection of 7500 IU Pregnyl to trigger final oocyte maturation |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- At least 14 follicles >11mm on the day of triggering final oocyte maturation
- Pretreated with GnRH antagonist protocol
Key exclusion criteria (2 listed)
- Poor responders
- Women with 25 or more follicles on the day of trigger
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 |
|---|---|---|
| rHCG 250ugAlso: OvitrelleInjection of 250 ug Ovitrelle to trigger final oocyte maturation | Drug | rHCG 250 ug |
| uHCG 5000 IUAlso: Pregnyl 5000 IUInjection of 5000 IU Pregnyl to trigger final oocyte maturation | Drug | uHCG 5000 IU |
| uHCG 7500 IUAlso: Pregnyl 7500 IUInjection of 7500 IU Pregnyl to trigger final oocyte maturation | Drug | uHCG 7500 IU |
Primary outcome
Percentage of mature oocytes
Time frame: Day of oocyte retrieval (Day 0)
Percentage MII/COCs
8 secondary outcomes
Positive test per embryo transfer
Time frame: 15 days post oocyte retrieval
Clinical pregnancy per embryo transfer
Time frame: 7 weeks of gestation
Ongoing pregnancy per embryo transfer
Time frame: 12 weeks of gestation
Level of serum hCG on day of oocyte retrieval
Time frame: Day of oocyte retrieval
Number of oocytes (COC) retrieved
Time frame: Day of oocyte retrieval
Number of mature oocytes (MII)
Time frame: Day of oocyte retrieval
Oocyte retrieval rate
Time frame: Day of oocyte retrieval (Day 0)
Incidence of severe early OHSS
Time frame: up to Day 5 post oocyte retrieval
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
- Background: PubMed 16848893Revelli A, Poso F, Gennarelli G, Moffa F, Grassi G, Massobrio M. Recombinant versus highly-purified, urinary follicle-stimulating hormone (r-FSH vs. HP-uFSH) in ovulation induction: a prospective, randomized study with cost-minimization analysis. Reprod Biol Endocrinol. 2006 Jul 18;4:38. doi: 10.1186/1477-7827-4-38.
- Background: PubMed 15846677Al-Inany HG, Aboulghar M, Mansour R, Proctor M. Recombinant versus urinary human chorionic gonadotrophin for ovulation induction in assisted conception. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD003719. doi: 10.1002/14651858.CD003719.pub2.
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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.
Tryfon Lainas, PhD principal investigator
Eugonia
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 rHCG 250ug, uHCG 5000 IU and uHCG 7500 IU in people with Infertility, run by Eugonia at 1 site in Greece.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Jan 2016. 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 Greece. 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?
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?
Percentage of mature oocytes (time frame: Day of oocyte retrieval (Day 0)). 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 NCT00415766, 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 20 Jan 2016.