Ovulation InductionNCT03307720
Agonist Versus Classical HCG Trigger (Poor Responders, Normoresponders and High Responders)
A study testing Gonadotropin Releasing Hormone Agonists (GNRH-A) and Human chorionic gonadotropin in people with Ovulation Induction and In Vitro Fertilization (IVF), run by Ginegorama S.L. at 1 site in Spain.
Trial summary
Agonist triggering in controlled ovarian stimulation protocols is being used during last years (among high responder patients to avoid OHSS). Indeed, agonist triggering is more physiologic than HCG triggering. Read more about this study
- Who is it for?
- Ages 18 to 48 years, women only
- Conditions the study is for
- Ovulation Induction, In Vitro Fertilization (IVF), Infertility, Female
- What is being tested?
- Gonadotropin Releasing Hormone Agonists (GNRH-A) and Human chorionic gonadotropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 18 Dec 2017to May 2018
- Phase
- Interventional
- 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 48 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women scheduled for IVF treatment.
- First ovarian stimulation
- Two ovaries present
- No previous ovarian surgery
- No contraindication for any of the assigned treatments
Who cannot join
- Previous ovarian surgery.
- Previous IVF treatments.
- Absence of one ovary
- Presence of an endometrioma
Trial locations and contacts
1 site in 1 country.
Amaia Garcia, PhD contact
Spain1 site
Reproduccion Bilbao Assisted Reproduction Center
Bilbao, Bizkaia, 48014
About this study
Official title: Agonist Trigger Versus Classical HCG Trigger in Controlled Ovarian Stimulation Among Three Different Subsets of Patients (Poor Responders, Normoresponders and High Responders)
Agonist triggering in controlled ovarian stimulation protocols is being used during last years (among high responder patients to avoid OHSS).
Indeed, agonist triggering is more physiologic than HCG triggering. Investigators propose to compare the effectiveness of both types of trigger among three different subsets of patients:
- Poor responders.
- Normo-responders
- High responders Comparing both the number and the quality of achieved oocytes.
Read the detailed description
During the last years, ovulation triggering in controlled ovarian stimulation protocols has been used specially to avoid hyperstimulation syndromes (OHSS). Indeed, the substitution of the classical HCG triggering by the agonist one, reduces almost to zero the risk of OHSS.
On the other hand poor responder patients to ovarian stimulation represent a challenge in assisted reproduction. Defining poor responders is not easy, but we can define them as those patients with less than 4 eggs obtained after oocyte retrieval.
Different strategies have been proposed to overcome this problem. In other words, to obtain more oocytes. These include an increase in FSH doses, an increase in FSH action by adding sensitizers agents.
Among the possible strategies, investigators propose the agonist triggering. HCG (classical) triggering represents the use of a LH-like product (with a prolonged action). The administration of a GnRH agonist provoke the production and liberation of both FSH and LH. Thus, the pro-ovulatory action is more physiologic , and possibly, more effective.
So, the use of a triggering protocol that nowadays is being used among high responders (thus reducing the OHSS risk) is proposed for both poor responder and normo-responder patients trying to achieve more oocytes, and specifically more mature oocytes.
- Being tested
- Gonadotropin Releasing Hormone Agonists (GNRH-A), Human chorionic gonadotropin
- Keywords
- agonist trigger, Ovulation induction, Controlled ovarian stimulation (COS), Poor responder
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gonadotropin Releasing Hormone Agonists (GNRH-A)Drug
Also called Agonist trigger
Administration of a gonadotropin releasing hormone agonist (GnRH-a) (0,2 ml) subcutaneously, 36 hours before ovum pick-up in IVF treatments.
Human chorionic gonadotropinDrug
Also called HCG trigger
Administration of Human chorionic gonadotropin (HCG) 250 IU subcutaneously , 36 hours before ovum pick-up in IVF treatments.
| Study group | Role | What they receive |
|---|---|---|
| Poor responders. Classical trigger | Active comparator | Intervention: HCG trigger (Administration of recombinant HCG 250 UI subcutaneously 36 prior to oocyte retrieval.
Women scheduled for IVF treatment with 4 or less antral follicles in ultrasound assessment. Receives: Drug: Human chorionic gonadotropin |
| Poor responders. Agonist trigger | Experimental | Intervention: Agonist trigger (administration of 0,2 mg of Triptoreline subcutaneously 36 hours prior to oocyte retrieval)
Women scheduled for IVF treatment with 4 or less antral follicles in ultrasound assessment. Receives: Drug: Gonadotropin Releasing Hormone Agonists (GNRH-A) |
| Normo responders. Classical trigger | Active comparator | Intervention: HCG trigger (Administration of recombinant HCG 250 UI subcutaneously 36 prior to oocyte retrieval.
Women scheduled for IVF treatment with more than 4 and less than 16 antral follicles in ultrasound assessment. Receives: Drug: Human chorionic gonadotropin |
| Normo responders. Agonist trigger | Experimental | Intervention: Agonist trigger (administration of 0,2 mg of Triptoreline subcutaneously 36 hours prior to oocyte retrieval)
Women scheduled for IVF treatment with more than 4 and less than 16 antral follicles in ultrasound assessment. Receives: Drug: Gonadotropin Releasing Hormone Agonists (GNRH-A) |
| High responders. Classical trigger | Active comparator | Intervention: HCG trigger (Administration of recombinant HCG 250 UI subcutaneously 36 prior to oocyte retrieval.
Women scheduled for IVF treatment with more than 15 antral follicles in ultrasound assessment. Receives: Drug: Human chorionic gonadotropin |
| High responders. Agonist trigger | Experimental | Intervention: Agonist trigger (administration of 0,2 mg of Triptoreline subcutaneously 36 hours prior to oocyte retrieval)
Women scheduled for IVF treatment with more than 15 antral follicles in ultrasound assessment. Receives: Drug: Gonadotropin Releasing Hormone Agonists (GNRH-A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mature oocytes
Number of mature oocytes achieved after oocyte retrieval.
Measured: Up to 24 weeks
Secondary outcomes (5)
Relation mature oocytes/punctured oocytes
Relation between the number of mature oocytes and the follicles.
Measured: Up to 24 weeks
Fertilized oocytes
Number of fertilized oocytes
Measured: Up to 24 weeks
Relation fertilized oocytes/achieved Mature oocytes
Relation between the number of fertilized oocytes and the mature oocytes achieved.
Measured: Up to 24 weeks
Number of blastocysts developed
Number of blastocysts developed in each arm of the study.
Measured: Up to 24 weeks
Cancelled cycles
Percentage of cancelled cycles
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start18 Dec 2017 (estimated)
- Primary completionFeb 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovulation InductionStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- IVF patients enrolled either to HCG or agonist trigger ovulation induction
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ginegorama S.L.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gorka Barrenetxea, Ginegorama S.L.
- Investigators
- Gorka Barrenetxea, PhD, Principal investigator, Reproducción Bilbao. Universidad del País Vasco/Euskal Herriko UnibertsitateaJon Iker Arambarri, MD, Study chair, Reproducción Bilbao. Universidad del País Vasco/Euskal Herriko Unibertsitatea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307720
- Sponsor's protocol ID
- AGONIST TRIGGER
- Status last verified
- Dec 2017
- First submitted
- 30 Sep 2017
- Last updated
- 11 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Agonist Trigger Versus Classical HCG Trigger in Controlled Ovarian Stimulation Among Three Different Subsets of Patients (Poor Responders, Normoresponders and High Responders)
- ClinicalTrials.gov ID
- NCT03307720
- Acronym / sponsor ID
- AGONIST TRIGGER
- Keywords
- agonist trigger, Ovulation induction, Controlled ovarian stimulation (COS), Poor responder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Ginegorama S.L.University, hospital or other
- Study start
- 18 Dec 2017 (estimated)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 12 Oct 2017 (actual)
- 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.
Agonist triggering in controlled ovarian stimulation protocols is being used during last years (among high responder patients to avoid OHSS).
Indeed, agonist triggering is more physiologic than HCG triggering. Investigators propose to compare the effectiveness of both types of trigger among three different subsets of patients:
- Poor responders.
- Normo-responders
- High responders Comparing both the number and the quality of achieved oocytes.
Detailed description
During the last years, ovulation triggering in controlled ovarian stimulation protocols has been used specially to avoid hyperstimulation syndromes (OHSS). Indeed, the substitution of the classical HCG triggering by the agonist one, reduces almost to zero the risk of OHSS.
On the other hand poor responder patients to ovarian stimulation represent a challenge in assisted reproduction. Defining poor responders is not easy, but we can define them as those patients with less than 4 eggs obtained after oocyte retrieval.
Different strategies have been proposed to overcome this problem. In other words, to obtain more oocytes. These include an increase in FSH doses, an increase in FSH action by adding sensitizers agents.
Among the possible strategies, investigators propose the agonist triggering. HCG (classical) triggering represents the use of a LH-like product (with a prolonged action). The administration of a GnRH agonist provoke the production and liberation of both FSH and LH. Thus, the pro-ovulatory action is more physiologic , and possibly, more effective.
So, the use of a triggering protocol that nowadays is being used among high responders (thus reducing the OHSS risk) is proposed for both poor responder and normo-responder patients trying to achieve more oocytes, and specifically more mature oocytes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- IVF patients enrolled either to HCG or agonist trigger ovulation induction
| Arm | Type | Receives |
|---|---|---|
| Poor responders. Classical trigger | Active comparator | Drug: Human chorionic gonadotropinIntervention: HCG trigger (Administration of recombinant HCG 250 UI subcutaneously 36 prior to oocyte retrieval. Women scheduled for IVF treatment with 4 or less antral follicles in ultrasound assessment. |
| Poor responders. Agonist trigger | Experimental | Drug: Gonadotropin Releasing Hormone Agonists (GNRH-A)Intervention: Agonist trigger (administration of 0,2 mg of Triptoreline subcutaneously 36 hours prior to oocyte retrieval) Women scheduled for IVF treatment with 4 or less antral follicles in ultrasound assessment. |
| Normo responders. Classical trigger | Active comparator | Drug: Human chorionic gonadotropinIntervention: HCG trigger (Administration of recombinant HCG 250 UI subcutaneously 36 prior to oocyte retrieval. Women scheduled for IVF treatment with more than 4 and less than 16 antral follicles in ultrasound assessment. |
| Normo responders. Agonist trigger | Experimental | Drug: Gonadotropin Releasing Hormone Agonists (GNRH-A)Intervention: Agonist trigger (administration of 0,2 mg of Triptoreline subcutaneously 36 hours prior to oocyte retrieval) Women scheduled for IVF treatment with more than 4 and less than 16 antral follicles in ultrasound assessment. |
| High responders. Classical trigger | Active comparator | Drug: Human chorionic gonadotropinIntervention: HCG trigger (Administration of recombinant HCG 250 UI subcutaneously 36 prior to oocyte retrieval. Women scheduled for IVF treatment with more than 15 antral follicles in ultrasound assessment. |
| High responders. Agonist trigger | Experimental | Drug: Gonadotropin Releasing Hormone Agonists (GNRH-A)Intervention: Agonist trigger (administration of 0,2 mg of Triptoreline subcutaneously 36 hours prior to oocyte retrieval) Women scheduled for IVF treatment with more than 15 antral follicles in ultrasound assessment. |
Who may qualify
- Ages
- 18 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women scheduled for IVF treatment.
- First ovarian stimulation
- Two ovaries present
- No previous ovarian surgery
- No contraindication for any of the assigned treatments
Key exclusion criteria (4 listed)
- Previous ovarian surgery.
- Previous IVF treatments.
- Absence of one ovary
- Presence of an endometrioma
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 |
|---|---|---|
| Gonadotropin Releasing Hormone Agonists (GNRH-A)Also: Agonist triggerAdministration of a gonadotropin releasing hormone agonist (GnRH-a) (0,2 ml) subcutaneously, 36 hours before ovum pick-up in IVF treatments. | Drug | High responders. Agonist trigger, Normo responders. Agonist trigger, Poor responders. Agonist trigger |
| Human chorionic gonadotropinAlso: HCG triggerAdministration of Human chorionic gonadotropin (HCG) 250 IU subcutaneously , 36 hours before ovum pick-up in IVF treatments. | Drug | High responders. Classical trigger, Normo responders. Classical trigger, Poor responders. Classical trigger |
Primary outcome
Mature oocytes
Time frame: Up to 24 weeks
Number of mature oocytes achieved after oocyte retrieval.
5 secondary outcomes
Relation mature oocytes/punctured oocytes
Time frame: Up to 24 weeks
Fertilized oocytes
Time frame: Up to 24 weeks
Relation fertilized oocytes/achieved Mature oocytes
Time frame: Up to 24 weeks
Number of blastocysts developed
Time frame: Up to 24 weeks
Cancelled cycles
Time frame: Up to 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
- Individual participant dataSharing planned: No
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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.
Amaia Garcia, PhD contact
Gorka Barrenetxea, PhD principal investigator
Reproducción Bilbao. Universidad del País Vasco/Euskal Herriko Unibertsitatea
Jon Iker Arambarri, MD study chair
Reproducción Bilbao. Universidad del País Vasco/Euskal Herriko Unibertsitatea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gonadotropin Releasing Hormone Agonists (GNRH-A) and Human chorionic gonadotropin in people with Ovulation Induction and In Vitro Fertilization (IVF), run by Ginegorama S.L. 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 5 inclusion and 4 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 Dec 2017. 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.
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 Gorka Barrenetxea, PhD (00 34 605711484, gbarrenetxea@reproduccionbilbao.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mature oocytes (time frame: Up to 24 weeks). 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 Dec 2017.