In-vitro FertilizationPhase 3NCT02862782
Combination of Gonadotropin-releasing Hormone Agonist and Human Chorionic Gonadotropin Triggered by Normal Responder in GnRH-antagonist Cycles
A Phase 3 study testing hCG (Ovitrelle 250 mcg mcg - Merck Serono) and hCG (Ovitrelle 250 mcg mcg - Merck Serono) + GnRH agonist (Decapeptyl 0.2mg - Ferring Gmgh) in people with In-vitro Fertilization, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Background The trigger for the final maturation of the ovum by providing integration of Human Chorionic Gonadotropin (hCG) and Gonadotropin - releasing hormone (GnRH) agonist was first introduced long ago, but clinically not accepted until the advent of GnRH antagonist protocol in IVF treatment. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- In-vitro Fertilization
- What is being tested?
- hCG (Ovitrelle 250 mcg mcg - Merck Serono) and hCG (Ovitrelle 250 mcg mcg - Merck Serono) + GnRH agonist (Decapeptyl 0.2mg - Ferring Gmgh)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Sep 2019
- Phase
- Phase 3
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women who are going through IVF by protocol GnRH - Antagonist
Who cannot join
- Women with Ovarian Hyperstimulation Syndrome
Trial locations and contacts
No sites are listed yet.
About this study
Background
The trigger for the final maturation of the ovum by providing integration of Human Chorionic Gonadotropin (hCG) and Gonadotropin - releasing hormone (GnRH) agonist was first introduced long ago, but clinically not accepted until the advent of GnRH antagonist protocol in IVF treatment.
Read more
In a recently published work which compared two types of ovulation induction (standard dose of hcg and in combination of GnRH agonist) in women with normal ovarian response, there was a statistically significant increase in the rates of implantation, clinical pregnancies and live births rates by providing integration of hCG and GnRH agonist.
To conclude, providing GnRH agonist in combination of hCF in standard dose is today an accepted treatment for final maturation of the ovums.
OBJECTIVE
The investigators objective is to investigate whether providing integrated treatment of Gonadotropin - releasing hormone (GnRH) Agonist and human Chorionic Gonadotropin (hCG) to final maturation of the ovum can improve the quality of the embryos, clinical pregnancies and live births rates in women treated with GnRH Antagonist protocol.
The main objective is to compare between two existing treatments.
Read the detailed description
Background
The trigger for the final maturation of the ovum by providing integration of Human Chorionic Gonadotropin (hCG) and Gonadotropin - releasing hormone (GnRH) agonist was first introduced long ago, but clinically not accepted until the advent of GnRH antagonist protocol in IVF treatment.
In order to prevent Ovarian Hyperstimulation Syndrome in the treatment cycles with GnRH antagonist protocol, it is possible to make the final maturation of the ovums by providing GnRH agonist.
In a recently published work which compared two types of ovulation induction (standard dose of hcg and in combination of GnRH agonist) in women with normal ovarian response, there was a statistically significant increase in the rates of implantation, clinical pregnancies and live births rates by providing integration of hCG and GnRH agonist.
To conclude, providing GnRH agonist in combination of hCF in standard dose is today an accepted treatment for final maturation of the ovums.
OBJECTIVE
The investigators objective is to investigate whether providing integrated treatment of Gonadotropin - releasing hormone (GnRH) Agonist and human Chorionic Gonadotropin (hCG) to final maturation of the ovum can improve the quality of the embryos, clinical pregnancies and live births rates in women treated with GnRH Antagonist protocol.
The main objective is to compare between two existing treatments.
PATIENTS \& METHODS
Women treated through IVF by protocol Gnarl - Antagonist
- Conditions
- In-vitro Fertilization
- Being tested
- hCG (Ovitrelle 250 mcg mcg - Merck Serono), hCG (Ovitrelle 250 mcg mcg - Merck Serono) + GnRH agonist (Decapeptyl 0.2mg - Ferring Gmgh)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hCG (Ovitrelle 250 mcg mcg - Merck Serono)Drug
hCG (Ovitrelle 250 mcg mcg - Merck Serono) + GnRH agonist (Decapeptyl 0.2mg - Ferring Gmgh)Drug
| Study group | Role | What they receive |
|---|---|---|
| hCG | Experimental | Injection of hCG - Human Chorionic Gonadotropin (Ovitrelle 250 mcg mcg - Merck Serono) Receives: Drug: hCG (Ovitrelle 250 mcg mcg - Merck Serono) |
| hCG + GnRH agonist | Experimental | Injection of hCG - Human Chorionic Gonadotropin (Ovitrelle 250 mcg mcg - Merck Serono) and GnRH agonist - Gonadotropin - releasing hormone (Decapeptyl 0.2mg - Ferring Gmgh) Receives: Drug: hCG (Ovitrelle 250 mcg mcg - Merck Serono) + GnRH agonist (Decapeptyl 0.2mg - Ferring Gmgh) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancies rate
Number of pregnancies per treatment Injection of hCG - Human Chorionic Gonadotropin (Ovitrelle 250 mcg mcg - Merck Serono) and GnRH agonist - Gonadotropin - releasing hormone (Decapeptyl 0.2mg - Ferring Gmgh) in comperesment to Human Chorionic Gonadotropin (Ovitrelle 250 mcg mcg - Merck Serono)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startSep 2016
- Primary completionSep 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In-vitro FertilizationStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Beni Almog, professor, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862782
- Sponsor's protocol ID
- 0317-16-TLV
- Status last verified
- Aug 2016
- First submitted
- 8 Aug 2016
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Gonadotropin-releasing Hormone Agonist and Human Chorionic Gonadotropin Triggered by Normal Responder in GnRH-antagonist Cycles
- ClinicalTrials.gov ID
- NCT02862782
- Acronym / sponsor ID
- 0317-16-TLV
- Conditions
- In-vitro Fertilization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Sep 2016
- Primary completion
- Sep 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 11 Aug 2016 (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.
Background
The trigger for the final maturation of the ovum by providing integration of Human Chorionic Gonadotropin (hCG) and Gonadotropin - releasing hormone (GnRH) agonist was first introduced long ago, but clinically not accepted until the advent of GnRH antagonist protocol in IVF treatment.
In a recently published work which compared two types of ovulation induction (standard dose of hcg and in combination of GnRH agonist) in women with normal ovarian response, there was a statistically significant increase in the rates of implantation, clinical pregnancies and live births rates by providing integration of hCG and GnRH agonist.
To conclude, providing GnRH agonist in combination of hCF in standard dose is today an accepted treatment for final maturation of the ovums.
OBJECTIVE
The investigators objective is to investigate whether providing integrated treatment of Gonadotropin - releasing hormone (GnRH) Agonist and human Chorionic Gonadotropin (hCG) to final maturation of the ovum can improve the quality of the embryos, clinical pregnancies and live births rates in women treated with GnRH Antagonist protocol.
The main objective is to compare between two existing treatments.
Detailed description
Background
The trigger for the final maturation of the ovum by providing integration of Human Chorionic Gonadotropin (hCG) and Gonadotropin - releasing hormone (GnRH) agonist was first introduced long ago, but clinically not accepted until the advent of GnRH antagonist protocol in IVF treatment.
In order to prevent Ovarian Hyperstimulation Syndrome in the treatment cycles with GnRH antagonist protocol, it is possible to make the final maturation of the ovums by providing GnRH agonist.
In a recently published work which compared two types of ovulation induction (standard dose of hcg and in combination of GnRH agonist) in women with normal ovarian response, there was a statistically significant increase in the rates of implantation, clinical pregnancies and live births rates by providing integration of hCG and GnRH agonist.
To conclude, providing GnRH agonist in combination of hCF in standard dose is today an accepted treatment for final maturation of the ovums.
OBJECTIVE
The investigators objective is to investigate whether providing integrated treatment of Gonadotropin - releasing hormone (GnRH) Agonist and human Chorionic Gonadotropin (hCG) to final maturation of the ovum can improve the quality of the embryos, clinical pregnancies and live births rates in women treated with GnRH Antagonist protocol.
The main objective is to compare between two existing treatments.
PATIENTS \& METHODS
Women treated through IVF by protocol Gnarl - Antagonist
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hCG | Experimental | Drug: hCG (Ovitrelle 250 mcg mcg - Merck Serono)Injection of hCG - Human Chorionic Gonadotropin (Ovitrelle 250 mcg mcg - Merck Serono) |
| hCG + GnRH agonist | Experimental | Drug: hCG (Ovitrelle 250 mcg mcg - Merck Serono) + GnRH agonist (Decapeptyl 0.2mg - Ferring Gmgh)Injection of hCG - Human Chorionic Gonadotropin (Ovitrelle 250 mcg mcg - Merck Serono) and GnRH agonist - Gonadotropin - releasing hormone (Decapeptyl 0.2mg - Ferring Gmgh) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women who are going through IVF by protocol GnRH - Antagonist
Key exclusion criteria (1 listed)
- Women with Ovarian Hyperstimulation Syndrome
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 |
|---|---|---|
| hCG (Ovitrelle 250 mcg mcg - Merck Serono) | Drug | hCG |
| hCG (Ovitrelle 250 mcg mcg - Merck Serono) + GnRH agonist (Decapeptyl 0.2mg - Ferring Gmgh) | Drug | hCG + GnRH agonist |
Primary outcome
Clinical pregnancies rate
Time frame: 1 month
Number of pregnancies per treatment Injection of hCG - Human Chorionic Gonadotropin (Ovitrelle 250 mcg mcg - Merck Serono) and GnRH agonist - Gonadotropin - releasing hormone (Decapeptyl 0.2mg - Ferring Gmgh) in comperesment to Human Chorionic Gonadotropin (Ovitrelle 250 mcg mcg - Merck Serono)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2016.
- Individual participant dataSharing planned: No
Related trials for In-vitro Fertilization
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
RecruitingPhase 2
Ubiquinone vs. Ubiquinol Supplementation
IVF
Recruiting
Trigger Timing in Ovarian Stimulations
IVF Outcome
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
RecruitingPhase 4
Study of G-CSF for DOR in Patients Undergoing IVF
Diminished Ovarian Reserve, IVF
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.
Beni Almog, professor principal investigator
Tel Aviv Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing hCG (Ovitrelle 250 mcg mcg - Merck Serono) and hCG (Ovitrelle 250 mcg mcg - Merck Serono) + GnRH agonist (Decapeptyl 0.2mg - Ferring Gmgh) in people with In-vitro Fertilization, run by Tel-Aviv Sourasky Medical Center.
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 1 inclusion and 1 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 11 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Beni Almog, professor (052-4266991, benia@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical pregnancies rate (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2016.