Female Urogenital DiseasesPhase 2TIMINGNCT02244151
Evaluation of Time Interval Between Ovulation Trigger With Triptorelin Acetate and Oocyte Retrieval
A Phase 2 study testing Decapeptyl® diario and Decapeptyl® daily in people with Female Urogenital Diseases, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
Trial summary
The aim of this study is to determine what is the best time interval between GnRH agonist (triptorelin acetate) ovulation induction allowing for the higher number of mature oocytes (MII) collected in IVF cycles. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Female Urogenital Diseases
- What is being tested?
- Decapeptyl® diario and Decapeptyl® daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2014to 2 Feb 2018
- Phase
- Phase 2
- 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 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Signed informed consent prior to carry out any procedure associated with the clinical trial.
- Women between 18 and 37 years of age at the time of randomization (both ages included).
- Basal serum levels of FSH <10 mIU /ml.
- Serum AMH > 5 to <45 pmol / l.
- Antral follicle count > 6 and < 24.
- Vaginal ultrasound documenting correct visualization of both ovaries and the absence of significant ovarian pathology.
- Short stimulation protocol with GnRH antagonist and conventional dose for ovarian stimulation with 225-300 UI of rhFSH.
- Number of follicles ≥ 16 mm > 5 on the ovulation induction day.
Who cannot join
- Presence of severe endometriosis (Grade III-IV).
- Absence of one ovary due to previous surgery.
- Presence of significant uterine pathology (submucous myomas, endometrial polyp, malformations..)
- Diagnosis of polycystic ovary syndrome (defined according to the Rotterdam criteria).
- History of previous poor response to conventional ovarian stimulation protocols (< 3 MII oocytes or canceled cycle)
- Severe male factor ( TMS< 1 million).
- Participation in another RCT within the past one year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Time Interval Between Ovulation Trigger With Triptorelin Acetate and Oocyte Retrieval in IVF Cycles: A Simple Blind, Randomized Controlled Trial.
The aim of this study is to determine what is the best time interval between GnRH agonist (triptorelin acetate) ovulation induction allowing for the higher number of mature oocytes (MII) collected in IVF cycles.
Read the detailed description
Human chorionic gonadotrophin (hCG) has been the gold standard for ovulation induction for several decades. When GnRH antagonist protocols were introduced, it became possible to trigger final oocyte maturation and ovulation with a single bolus of a GnRH agonist (GnRHa) as an alternative to hCG. The use of GnRHa to trigger final oocyte maturation has potential advantages: the simultaneous induction of a FSH surge, higher numbers of mature oocytes retrieved as compared to hCG and the total elimination of ovarian hyperstimulation syndrome.
From the earliest reports of GnRHa for ovulation triggering, it has been presumed that the timing of the ovum pick-up (OPU) after GnRHa administration should be the same as after hCG triggering (34-36 h). However, differences exist regarding the duration and profile of the GnRHa induced surge of gonadotrophins when compared with that of hCG. Even more, differences in the intra-follicular mechanisms involved in ovulation have been described after GnRHa and hCG trigger.
No previous randomized controlled trials have been reported to evaluate the optimal interval of time between ovulation induction by GnRHa and oocyte collection.
The present study compares the ovarian response and the IVF outcomes after induction by triptorelin 0.2 mg at four different time intervals:
Group 1: OPU 24 hours after GnRHa administration. Group 2: OPU 30 hours after GnRHa administration. Group 3: OPU 40 hours after GnRHa administration. Group 4: control group: OPU 36 hours after GnRHa administration.
- Conditions
- Female Urogenital Diseases
- Being tested
- Decapeptyl® diario, Decapeptyl® daily
- Keywords
- ovulation induction,oocyte maturation timing and collection
- Medical subject headings
- Female Urogenital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decapeptyl® diarioDrug
Also called Decapeptyl® daily; GnRHa
Decapeptyl® daily administration (Triptorelin acetate) and follicular puncture at 24, 30, 36 or 40 after administration.
Decapeptyl® dailyDrug
Also called Decapeptyl® diario; GnRHa
Decapeptyl® daily OPU 36 hrs after GnRH administration
| Study group | Role | What they receive |
|---|---|---|
| DECAPEPTYL® diario | Experimental | Group 1: DECAPEPTYL® diario,OPU 24 hours after GnRHa administration. Receives: Drug: Decapeptyl® diario |
| Decapeptyl® diaro | Experimental | Group 2:Decapeptyl® diario OPU 30 hours after GnRHa administration. Receives: Drug: Decapeptyl® diario |
| Decapeptyl® diario. | Experimental | Group 3: Decapeptyl® diario, OPU 40 hours after GnRHa administration. Receives: Drug: Decapeptyl® diario |
| Decapeptyl® daily | Active comparator | Group 4: Decapeptyl® daily OPU 36 hrs after GnRH administration Receives: Drug: Decapeptyl® daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of mature oocytes 24 hours post Decapeptyl administration
The trial pretends to determine the interval time needed for final oocyte maturation and ovulation after triptorelin administration.
Measured: 24 hours post Decapeptyl administration
Number of mature oocytes 30 hours post Decapeptyl administration
The trial pretends to determine the interval time needed for final oocyte maturation and ovulation after triptorelin administration.
Measured: 30 hours post Decapeptyl administration
Number of mature oocytes 36 hours post Decapeptyl administration
The trial pretends to determine the interval time needed for final oocyte maturation and ovulation after triptorelin administration.
Measured: 36 hours post Decapeptyl administration
Number of mature oocytes 40 hours post Decapeptyl administration
The trial pretends to determine the interval time needed for final oocyte maturation and ovulation after triptorelin administration.
Measured: 40 hours post Decapeptyl administration
Secondary outcomes (4)
Total number of follicles > 16 mm punctured.
Total number of follicles > 16 mm punctured.
Measured: Time 0 (when Decapeptyl administration)
Total number of oocytes retrieved
Total number of oocytes retrieved
Measured: 24, 30, 36 and 40 hours post Decapeptyl administration
Serum and follicular fluid levels of Amphiregulin (AR) and Epiregulin
Serum and follicular fluid levels of Amphiregulin (AR) and Epiregulin
Measured: 24, 30, 36 and 40 hours post Decapeptyl administration
Serum and follicular fluid hormonal levels (estradiol , LH and progesterone)
Serum and follicular fluid hormonal levels (estradiol , LH and progesterone)
Measured: Time 0 (when Decapeptyl administration) , 12 hours after Decapeptyl administration , OPU moment and day of embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study startSep 2014
- Primary completion1 Feb 2018
- Study completion2 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Urogenital DiseasesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigacion Sanitaria La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alicia Marzal, M.D, Principal investigator, Grupo de Investigación en Medicina Reproductiva, IIS La Fe, Valencia ; SpainCésar Díaz-García, M.D, Study chair, Unidad de Reproducción Humana, Area de Salud de la Mujer, Hospital Universitaria La Fe, Valencia, Spain. Grupo de Investigación en Medicina Reproductiva, IIS La Fe, Valencia ; SpainAntonio Pellicer, Professor, Study director, Unidad de Reproducción Humana, Area de Salud de la Mujer, Hospital Universitaria La Fe, Valencia, Spain. Grupo de Investigación en Medicina Reproductiva, IIS La Fe, Valencia ; Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244151
- Sponsor's protocol ID
- TIMING
- Other IDs
- 2012-005571-14
- Acronym
- TIMING
- Status last verified
- Aug 2017
- First submitted
- 17 Jun 2014
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Time Interval Between Ovulation Trigger With Triptorelin Acetate and Oocyte Retrieval in IVF Cycles: A Simple Blind, Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02244151
- Acronym / sponsor ID
- TIMING / TIMING
- Conditions
- Female Urogenital Diseases
- Keywords
- ovulation induction,oocyte maturation timing and collection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Instituto de Investigacion Sanitaria La FeUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 2 Feb 2018 (actual)
- First posted
- 18 Sep 2014 (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 aim of this study is to determine what is the best time interval between GnRH agonist (triptorelin acetate) ovulation induction allowing for the higher number of mature oocytes (MII) collected in IVF cycles.
Detailed description
Human chorionic gonadotrophin (hCG) has been the gold standard for ovulation induction for several decades. When GnRH antagonist protocols were introduced, it became possible to trigger final oocyte maturation and ovulation with a single bolus of a GnRH agonist (GnRHa) as an alternative to hCG. The use of GnRHa to trigger final oocyte maturation has potential advantages: the simultaneous induction of a FSH surge, higher numbers of mature oocytes retrieved as compared to hCG and the total elimination of ovarian hyperstimulation syndrome.
From the earliest reports of GnRHa for ovulation triggering, it has been presumed that the timing of the ovum pick-up (OPU) after GnRHa administration should be the same as after hCG triggering (34-36 h). However, differences exist regarding the duration and profile of the GnRHa induced surge of gonadotrophins when compared with that of hCG. Even more, differences in the intra-follicular mechanisms involved in ovulation have been described after GnRHa and hCG trigger.
No previous randomized controlled trials have been reported to evaluate the optimal interval of time between ovulation induction by GnRHa and oocyte collection.
The present study compares the ovarian response and the IVF outcomes after induction by triptorelin 0.2 mg at four different time intervals:
Group 1: OPU 24 hours after GnRHa administration. Group 2: OPU 30 hours after GnRHa administration. Group 3: OPU 40 hours after GnRHa administration. Group 4: control group: OPU 36 hours after GnRHa administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DECAPEPTYL® diario | Experimental | Drug: Decapeptyl® diarioGroup 1: DECAPEPTYL® diario,OPU 24 hours after GnRHa administration. |
| Decapeptyl® diaro | Experimental | Drug: Decapeptyl® diarioGroup 2:Decapeptyl® diario OPU 30 hours after GnRHa administration. |
| Decapeptyl® diario. | Experimental | Drug: Decapeptyl® diarioGroup 3: Decapeptyl® diario, OPU 40 hours after GnRHa administration. |
| Decapeptyl® daily | Active comparator | Drug: Decapeptyl® dailyGroup 4: Decapeptyl® daily OPU 36 hrs after GnRH administration |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Signed informed consent prior to carry out any procedure associated with the clinical trial.
- Women between 18 and 37 years of age at the time of randomization (both ages included).
- Basal serum levels of FSH <10 mIU /ml.
- Serum AMH > 5 to <45 pmol / l.
- Antral follicle count > 6 and < 24.
Key exclusion criteria (7 listed)
- Presence of severe endometriosis (Grade III-IV).
- Absence of one ovary due to previous surgery.
- Presence of significant uterine pathology (submucous myomas, endometrial polyp, malformations..)
- Diagnosis of polycystic ovary syndrome (defined according to the Rotterdam criteria).
- History of previous poor response to conventional ovarian stimulation protocols (< 3 MII oocytes or canceled cycle)
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 |
|---|---|---|
| Decapeptyl® diarioAlso: Decapeptyl® daily; GnRHaDecapeptyl® daily administration (Triptorelin acetate) and follicular puncture at 24, 30, 36 or 40 after administration. | Drug | DECAPEPTYL® diario, Decapeptyl® diario., Decapeptyl® diaro |
| Decapeptyl® dailyAlso: Decapeptyl® diario; GnRHaDecapeptyl® daily OPU 36 hrs after GnRH administration | Drug | Decapeptyl® daily |
Primary outcome
Number of mature oocytes 24 hours post Decapeptyl administration
Time frame: 24 hours post Decapeptyl administration
The trial pretends to determine the interval time needed for final oocyte maturation and ovulation after triptorelin administration.
Number of mature oocytes 30 hours post Decapeptyl administration
Time frame: 30 hours post Decapeptyl administration
The trial pretends to determine the interval time needed for final oocyte maturation and ovulation after triptorelin administration.
Number of mature oocytes 36 hours post Decapeptyl administration
Time frame: 36 hours post Decapeptyl administration
The trial pretends to determine the interval time needed for final oocyte maturation and ovulation after triptorelin administration.
Number of mature oocytes 40 hours post Decapeptyl administration
Time frame: 40 hours post Decapeptyl administration
The trial pretends to determine the interval time needed for final oocyte maturation and ovulation after triptorelin administration.
4 secondary outcomes
Total number of follicles > 16 mm punctured.
Time frame: Time 0 (when Decapeptyl administration)
Total number of oocytes retrieved
Time frame: 24, 30, 36 and 40 hours post Decapeptyl administration
Serum and follicular fluid levels of Amphiregulin (AR) and Epiregulin
Time frame: 24, 30, 36 and 40 hours post Decapeptyl administration
Serum and follicular fluid hormonal levels (estradiol , LH and progesterone)
Time frame: Time 0 (when Decapeptyl administration) , 12 hours after Decapeptyl administration , OPU moment and day of embryo transfer
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 15 Feb 2018.
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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.
Alicia Marzal, M.D principal investigator
Grupo de Investigación en Medicina Reproductiva, IIS La Fe, Valencia ; Spain
César Díaz-García, M.D study chair
Unidad de Reproducción Humana, Area de Salud de la Mujer, Hospital Universitaria La Fe, Valencia, Spain. Grupo de Investigación en Medicina Reproductiva, IIS La Fe, Valencia ; Spain
Antonio Pellicer, Professor study director
Unidad de Reproducción Humana, Area de Salud de la Mujer, Hospital Universitaria La Fe, Valencia, Spain. Grupo de Investigación en Medicina Reproductiva, IIS La Fe, Valencia ; Spain.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Decapeptyl® diario and Decapeptyl® daily in people with Female Urogenital Diseases, run by Instituto de Investigacion Sanitaria La Fe 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 8 inclusion and 7 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 15 Feb 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number of mature oocytes 24 hours post Decapeptyl administration (time frame: 24 hours post Decapeptyl administration). The study lists 4 primary outcomes in all. 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 15 Feb 2018.