INFERTILITYNCT02813239
Dual Triggering in Patients With a High Immature Oocyte Rate
An observational study of INFERTILITY, run by IVI Madrid.
Trial summary
In in vitro fertilization (IVF) cycles, even after adequate triggering, some patients present a high rate of immature oocytes retrieved after controlled ovarian stimulation. In vitro oocyte maturation is still an experimental technique, with poorer results than conventional IVF. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- INFERTILITY
- What is being tested?
- hCG and hCG + GnRH agonist
- Type of treatment
- Pill or oral medicine
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Nov 2015
- Phase
- Observational
- 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 43 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women undergoing controlled ovarian stimulation with a high immature oocyte rate
Who may be able to join
- BMI of 18-30 kg/m2
- Male factor required for ICSI
Who cannot join
- -
About this study
Official title: Dual Triggering With Gonadotropin-releasing Hormone Agonist and Standard Dose Human Chorionic Gonadotropin in Patients With a High Immature Oocyte Rate
In in vitro fertilization (IVF) cycles, even after adequate triggering, some patients present a high rate of immature oocytes retrieved after controlled ovarian stimulation. In vitro oocyte maturation is still an experimental technique, with poorer results than conventional IVF. For that reason improve in in vivo maturation could have a better impact on reproductive outcome.
Read the detailed description
Investigators performed an observational study analyzing the difference in the percentage of mature oocytes retrieved in patients with more than 50% immature oocytes in a previous IVF cycle triggered with human chorionic gonadotropin (rhCG) compared to the rate of mature oocytes retrieved in subsequent cycles, triggered with both gonadotropin-releasing hormone agonist (GnRHa) and (hCG). The main outcome measure was the number and percentage of mature oocytes retrieved.
- Conditions
- INFERTILITY
- Being tested
- hCG, hCG + GnRH agonist
- Keywords
- IVF, Dual trigger, GnRH agonist, hCG, mature oocytes
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hCGOther
Also called OVITRELLE (Merck Serono)
Oocyte maturation with hCG
hCG + GnRH agonistOther
Also called Ovitrelle (Merck Serono) + Decapeptyl (Ipsen Pharma)
Oocyte maturation with hCG + GnRH agonist
| Study group | Role | What they receive |
|---|---|---|
| HCG triggering | Patients were scheduled by prescribing oral contraceptive (OC) for 12-16 days and recombinant FSH and/or highly purified u-hMG according to the patient's age, BMI, antral follicular count, AMH and previous responses to ovarian controlled stimulation. GnRH antagonist was added when at least one follicle reached 13 mm. Ovulation was induced by hCG when at least 2 follicles had a mean diameter of 17 mm. Receives: Other: hCG | |
| HCG + GnRH agonist triggering | Patients were scheduled by prescribing oral contraceptive (OC) for 12-16 days and recombinant FSH and/or highly purified u-hMG according to the patient's age, BMI, antral follicular count, AMH and previous responses to ovarian controlled stimulation. GnRH antagonist was added when at least one follicle reached 13 mm. Ovulation was induced by hCG and GnRH agonist when at least 2 follicles had a mean diameter of 17 mm. Receives: Other: hCG + GnRH agonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metaphase II rate
Number of metaphase II among total of recovered oocytes
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startNov 2014
- Primary completionNov 2014
- Study completionNov 2015
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
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan A Garcia-Velasco, IVI Madrid
- Investigators
- Juan Antonio Garcia Velasco, MD, Principal investigator, IVI Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813239
- Sponsor's protocol ID
- 1408-MAD-058-JG
- Status last verified
- Jun 2016
- First submitted
- 16 Jun 2016
- Last updated
- 24 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fatemi HM, Garcia-Velasco J. Avoiding ovarian hyperstimulation syndrome with the use of gonadotropin-releasing hormone agonist trigger. Fertil Steril. 2015 Apr;103(4):870-3. doi: 10.1016/j.fertnstert.2015.02.004. Epub 2015 Feb 24.
PubMed 25724740Kohls G, Ruiz F, Martinez M, Hauzman E, de la Fuente G, Pellicer A, Garcia-Velasco JA. Early progesterone cessation after in vitro fertilization/intracytoplasmic sperm injection: a randomized, controlled trial. Fertil Steril. 2012 Oct;98(4):858-62. doi: 10.1016/j.fertnstert.2012.05.046. Epub 2012 Jun 29.
PubMed 22749223
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Triggering With Gonadotropin-releasing Hormone Agonist and Standard Dose Human Chorionic Gonadotropin in Patients With a High Immature Oocyte Rate
- ClinicalTrials.gov ID
- NCT02813239
- Acronym / sponsor ID
- 1408-MAD-058-JG
- Conditions
- INFERTILITY
- Keywords
- IVF, Dual trigger, GnRH agonist, hCG, mature oocytes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- IVI MadridUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 24 Jun 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.
In in vitro fertilization (IVF) cycles, even after adequate triggering, some patients present a high rate of immature oocytes retrieved after controlled ovarian stimulation. In vitro oocyte maturation is still an experimental technique, with poorer results than conventional IVF. For that reason improve in in vivo maturation could have a better impact on reproductive outcome.
Detailed description
Investigators performed an observational study analyzing the difference in the percentage of mature oocytes retrieved in patients with more than 50% immature oocytes in a previous IVF cycle triggered with human chorionic gonadotropin (rhCG) compared to the rate of mature oocytes retrieved in subsequent cycles, triggered with both gonadotropin-releasing hormone agonist (GnRHa) and (hCG). The main outcome measure was the number and percentage of mature oocytes retrieved.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCG triggering | – | Other: hCGPatients were scheduled by prescribing oral contraceptive (OC) for 12-16 days and recombinant FSH and/or highly purified u-hMG according to the patient's age, BMI, antral follicular count, AMH and previous responses to ovarian controlled stimulation. GnRH antagonist was added when at least one follicle reached 13 mm. Ovulation was induced by hCG when at least 2 follicles had a mean diameter of 17 mm. |
| HCG + GnRH agonist triggering | – | Other: hCG + GnRH agonistPatients were scheduled by prescribing oral contraceptive (OC) for 12-16 days and recombinant FSH and/or highly purified u-hMG according to the patient's age, BMI, antral follicular count, AMH and previous responses to ovarian controlled stimulation. GnRH antagonist was added when at least one follicle reached 13 mm. Ovulation was induced by hCG and GnRH agonist when at least 2 follicles had a mean diameter of 17 mm. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women undergoing controlled ovarian stimulation with a high immature oocyte rate
Key inclusion criteria (2 listed)
- BMI of 18-30 kg/m2
- Male factor required for ICSI
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| hCGAlso: OVITRELLE (Merck Serono)Oocyte maturation with hCG | Other | HCG triggering |
| hCG + GnRH agonistAlso: Ovitrelle (Merck Serono) + Decapeptyl (Ipsen Pharma)Oocyte maturation with hCG + GnRH agonist | Other | HCG + GnRH agonist triggering |
Primary outcome
Metaphase II rate
Time frame: 1 day
Number of metaphase II among total of recovered oocytes
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 24 Jun 2016.
- Background: PubMed 25724740Fatemi HM, Garcia-Velasco J. Avoiding ovarian hyperstimulation syndrome with the use of gonadotropin-releasing hormone agonist trigger. Fertil Steril. 2015 Apr;103(4):870-3. doi: 10.1016/j.fertnstert.2015.02.004. Epub 2015 Feb 24.
- Background: PubMed 22749223Kohls G, Ruiz F, Martinez M, Hauzman E, de la Fuente G, Pellicer A, Garcia-Velasco JA. Early progesterone cessation after in vitro fertilization/intracytoplasmic sperm injection: a randomized, controlled trial. Fertil Steril. 2012 Oct;98(4):858-62. doi: 10.1016/j.fertnstert.2012.05.046. Epub 2012 Jun 29.
- 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.
Juan Antonio Garcia Velasco, MD principal investigator
IVI Madrid
Questions about this trial
What is this clinical trial studying?
An observational study of INFERTILITY, run by IVI Madrid.
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 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: finished, as of the sponsor's last update on 24 Jun 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.
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?
Metaphase II rate (time frame: 1 day). 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 NCT02813239, 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 24 Jun 2016.