IVFPhase 4COTRIDNCT05321511
Comparison of Triggers in Double Ovarian Stimulation (DuoStim).
A Phase 4 study testing Triptorelin acetate (a-GnRH), Ovitrelle® (hCG) and Decapeptyl 0.1 mg® (a-GnRH) and Ovitrelle® (hCG) used together in people with IVF and LOW OVARIAN RESPONSE, run by Instituto Bernabeu at 4 sites in Spain.
Trial summary
This study aims to investigate the efficacy of 3 different trigggers used for final maturation in the second ovarian stimulation in double stimulation protocol (aGnRH and hCG-rec vs. aGnRH only vs. hCG-rec only). Read more about this study
- Who is it for?
- Ages 28 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- IVF, LOW OVARIAN RESPONSE
- What is being tested?
- Triptorelin acetate (a-GnRH), Ovitrelle® (hCG) and Decapeptyl 0.1 mg® (a-GnRH) and Ovitrelle® (hCG) used together
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 4 sitesSpain
- Study dates
- 3 Mar 2022to 31 Mar 2023
- 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 28 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI below 32
- Presence of both ovaries
- Indication for ovarian stimulation under Double Stimulation protocol (Duo Stim)
- Meeting the criteria for Duo Stim
- Medical history, history and physical examination without alterations
- AMH and AFV results in accordnace to Poseidon classification group 3 or 4 no more than 6 months prior to signing the consent form
Show all 9Show fewer
- Ability to participate and comply with the study protocol.
- To have given written consent
- Normal karyotype and fragile X.
Who cannot join
- Non-compliance with instructions and/or non-formalization of consents or legal requirements for IVF.
- Concurrent participation in another study
Trial locations and contacts
4 sites in 1 country.
Spain4 sites, 4 recruiting
- Recruiting
Instituto Bernabeu
Albacete, 02005
Anna Pitas, PhD, +34663926079, apitas@institutobernabeu.com
Lydia Luque, Dr.
- Recruiting
Instituto Bernabeu
Alicante, 03016
Anna Pitas, PhD, +34663926079, apitas@institutobernabeu.com
Andrea Bernabeu, Dr.
- Recruiting
Instituto Bernabeu
Madrid, 28001
Anna Pitas, PhD, +34663926079, apitas@institutobernabeu.com
Ruth Romero, Dr.
- Recruiting
Instituto Bernabeu
Palma de Mallorca, Mallorca, 07006
Anna Pitas, PhD, +34663926079, apitas@institutobernabeu.com
Jordi Suñol, Dr.
About this study
Official title: Double Ovarian Stimulation (DuoStim) Comparison of Triggers: Is There Any Advantage Using 3 Different Methods of Trigger for the Second Egg Collection in Predicted Low Responders?
This study aims to investigate the efficacy of 3 different trigggers used for final maturation in the second ovarian stimulation in double stimulation protocol (aGnRH and hCG-rec vs. aGnRH only vs. hCG-rec only). The main objective is to compare the number of all retrieved oocytes and mature oocytes in patients predicted to be low ovarian responders.
This is a controlled randomized clinical study where 165 patients will be recruited.
- Conditions
- IVF, LOW OVARIAN RESPONSE
- Being tested
- Triptorelin acetate (a-GnRH), Ovitrelle® (hCG), Decapeptyl 0.1 mg® (a-GnRH) and Ovitrelle® (hCG) used together
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triptorelin acetate (a-GnRH)Drug
Also called Decapeptyl 0.1 mg®
Adminsitration of triptoreline acetate 0.2 mg for final oocyte maturation in the second ovarian stimuation inthe Double stimulation protocol.
Ovitrelle® (hCG)Drug
Adminsitration of coriogonadotropine alfa 250 mcg for final oocyte maturation in the second ovarian stimuation inthe Double stimulation protocol.
Decapeptyl 0.1 mg® (a-GnRH) and Ovitrelle® (hCG) used togetherDrug
Adminsitration of triptoreline acetate 0.2 mg and coriogonadotropine alfa 250 mcg for final oocyte maturation in the second ovarian stimuation inthe Double stimulation protocol.
| Study group | Role | What they receive |
|---|---|---|
| a-GnRH | Active comparator | Administration of triptorelin acetate 0.2 mg for final oocyte maturation. Receives: Drug: Triptorelin acetate (a-GnRH) |
| hCG | Active comparator | Administration of coriogonadotropine alfa 250 mcg for final oocyte maturation. Receives: Drug: Ovitrelle® (hCG) |
| a-GnRH + hCG | Experimental | Administration of triptorelin acetate 0.2 mg and coriogonadotropine alfa 250 mcg for final oocyte maturation. Receives: Drug: Decapeptyl 0.1 mg® (a-GnRH) and Ovitrelle® (hCG) used together |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of retrieved oocytes
number of oocytes retrieved in the second ovarian stimulation in the double stimulation protocol.
Measured: through study completion, usually will be evaluated on the last day of the treatment
number of mature (MII) oocytes
number of mature (MII) oocytes retrieved in the second ovarian stimulation in the double stimulation protocol.
Measured: through study completion, usually will be evaluated on the last day of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start3 Mar 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for IVFStudies 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
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Bernabeu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Bernabeu García, Instituto Bernabeu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321511
- Sponsor's protocol ID
- IB-0121
- Acronym
- COTRID
- Status last verified
- Apr 2022
- First submitted
- 24 Mar 2022
- Last updated
- 11 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Castillo JC, Haahr T, Martinez-Moya M, Humaidan P. Gonadotropin-releasing hormone agonist ovulation trigger-beyond OHSS prevention. Ups J Med Sci. 2020 May;125(2):138-143. doi: 10.1080/03009734.2020.1737599. Epub 2020 Mar 25.
PubMed 32208810Pereira N, Elias RT, Neri QV, Gerber RS, Lekovich JP, Palermo GD, Rosenwaks Z. Adjuvant gonadotrophin-releasing hormone agonist trigger with human chorionic gonadotrophin to enhance ooplasmic maturity. Reprod Biomed Online. 2016 Nov;33(5):568-574. doi: 10.1016/j.rbmo.2016.08.009. Epub 2016 Aug 20.
PubMed 27567429Moffat R, Pirtea P, Gayet V, Wolf JP, Chapron C, de Ziegler D. Dual ovarian stimulation is a new viable option for enhancing the oocyte yield when the time for assisted reproductive technnology is limited. Reprod Biomed Online. 2014 Dec;29(6):659-61. doi: 10.1016/j.rbmo.2014.08.010. Epub 2014 Sep 4.
PubMed 25311972Lin MH, Wu FS, Hwu YM, Lee RK, Li RS, Li SH. Dual trigger with gonadotropin releasing hormone agonist and human chorionic gonadotropin significantly improves live birth rate for women with diminished ovarian reserve. Reprod Biol Endocrinol. 2019 Jan 4;17(1):7. doi: 10.1186/s12958-018-0451-x.
PubMed 30609935Haas J, Zilberberg E, Dar S, Kedem A, Machtinger R, Orvieto R. Co-administration of GnRH-agonist and hCG for final oocyte maturation (double trigger) in patients with low number of oocytes retrieved per number of preovulatory follicles--a preliminary report. J Ovarian Res. 2014 Aug 2;7:77. doi: 10.1186/1757-2215-7-77.
PubMed 25296696Zhang J, Wang Y, Mao X, Chen Q, Hong Q, Cai R, Zhang S, Kuang Y. Dual trigger of final oocyte maturation in poor ovarian responders undergoing IVF/ICSI cycles. Reprod Biomed Online. 2017 Dec;35(6):701-707. doi: 10.1016/j.rbmo.2017.09.002. Epub 2017 Sep 21.
PubMed 28993105
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Ovarian Stimulation (DuoStim) Comparison of Triggers: Is There Any Advantage Using 3 Different Methods of Trigger for the Second Egg Collection in Predicted Low Responders?
- ClinicalTrials.gov ID
- NCT05321511
- Acronym / sponsor ID
- COTRID / IB-0121
- Conditions
- IVF, LOW OVARIAN RESPONSE
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Instituto BernabeuUniversity, hospital or other
- Study start
- 3 Mar 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 11 Apr 2022 (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.
This study aims to investigate the efficacy of 3 different trigggers used for final maturation in the second ovarian stimulation in double stimulation protocol (aGnRH and hCG-rec vs. aGnRH only vs. hCG-rec only). The main objective is to compare the number of all retrieved oocytes and mature oocytes in patients predicted to be low ovarian responders.
This is a controlled randomized clinical study where 165 patients will be recruited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| a-GnRH | Active comparator | Drug: Triptorelin acetate (a-GnRH)Administration of triptorelin acetate 0.2 mg for final oocyte maturation. |
| hCG | Active comparator | Drug: Ovitrelle® (hCG)Administration of coriogonadotropine alfa 250 mcg for final oocyte maturation. |
| a-GnRH + hCG | Experimental | Drug: Decapeptyl 0.1 mg® (a-GnRH) and Ovitrelle® (hCG) used togetherAdministration of triptorelin acetate 0.2 mg and coriogonadotropine alfa 250 mcg for final oocyte maturation. |
Who may qualify
- Ages
- 28 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- BMI below 32
- Presence of both ovaries
- Indication for ovarian stimulation under Double Stimulation protocol (Duo Stim)
- Meeting the criteria for Duo Stim
- Medical history, history and physical examination without alterations
Key exclusion criteria (2 listed)
- Non-compliance with instructions and/or non-formalization of consents or legal requirements for IVF.
- Concurrent participation in another study
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 |
|---|---|---|
| Triptorelin acetate (a-GnRH)Also: Decapeptyl 0.1 mg®Adminsitration of triptoreline acetate 0.2 mg for final oocyte maturation in the second ovarian stimuation inthe Double stimulation protocol. | Drug | a-GnRH |
| Ovitrelle® (hCG)Adminsitration of coriogonadotropine alfa 250 mcg for final oocyte maturation in the second ovarian stimuation inthe Double stimulation protocol. | Drug | hCG |
| Decapeptyl 0.1 mg® (a-GnRH) and Ovitrelle® (hCG) used togetherAdminsitration of triptoreline acetate 0.2 mg and coriogonadotropine alfa 250 mcg for final oocyte maturation in the second ovarian stimuation inthe Double stimulation protocol. | Drug | a-GnRH + hCG |
Primary outcome
number of retrieved oocytes
Time frame: through study completion, usually will be evaluated on the last day of the treatment
number of oocytes retrieved in the second ovarian stimulation in the double stimulation protocol.
number of mature (MII) oocytes
Time frame: through study completion, usually will be evaluated on the last day of the treatment
number of mature (MII) oocytes retrieved in the second ovarian stimulation in the double stimulation protocol.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Results publication: PubMed 32208810Castillo JC, Haahr T, Martinez-Moya M, Humaidan P. Gonadotropin-releasing hormone agonist ovulation trigger-beyond OHSS prevention. Ups J Med Sci. 2020 May;125(2):138-143. doi: 10.1080/03009734.2020.1737599. Epub 2020 Mar 25.
- Results publication: PubMed 27567429Pereira N, Elias RT, Neri QV, Gerber RS, Lekovich JP, Palermo GD, Rosenwaks Z. Adjuvant gonadotrophin-releasing hormone agonist trigger with human chorionic gonadotrophin to enhance ooplasmic maturity. Reprod Biomed Online. 2016 Nov;33(5):568-574. doi: 10.1016/j.rbmo.2016.08.009. Epub 2016 Aug 20.
- Results publication: PubMed 25311972Moffat R, Pirtea P, Gayet V, Wolf JP, Chapron C, de Ziegler D. Dual ovarian stimulation is a new viable option for enhancing the oocyte yield when the time for assisted reproductive technnology is limited. Reprod Biomed Online. 2014 Dec;29(6):659-61. doi: 10.1016/j.rbmo.2014.08.010. Epub 2014 Sep 4.
- Results publication: PubMed 30609935Lin MH, Wu FS, Hwu YM, Lee RK, Li RS, Li SH. Dual trigger with gonadotropin releasing hormone agonist and human chorionic gonadotropin significantly improves live birth rate for women with diminished ovarian reserve. Reprod Biol Endocrinol. 2019 Jan 4;17(1):7. doi: 10.1186/s12958-018-0451-x.
- Results publication: PubMed 25296696Haas J, Zilberberg E, Dar S, Kedem A, Machtinger R, Orvieto R. Co-administration of GnRH-agonist and hCG for final oocyte maturation (double trigger) in patients with low number of oocytes retrieved per number of preovulatory follicles--a preliminary report. J Ovarian Res. 2014 Aug 2;7:77. doi: 10.1186/1757-2215-7-77.
- Results publication: PubMed 28993105Zhang J, Wang Y, Mao X, Chen Q, Hong Q, Cai R, Zhang S, Kuang Y. Dual trigger of final oocyte maturation in poor ovarian responders undergoing IVF/ICSI cycles. Reprod Biomed Online. 2017 Dec;35(6):701-707. doi: 10.1016/j.rbmo.2017.09.002. Epub 2017 Sep 21.
- 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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Triptorelin acetate (a-GnRH), Ovitrelle® (hCG) and Decapeptyl 0.1 mg® (a-GnRH) and Ovitrelle® (hCG) used together in people with IVF and LOW OVARIAN RESPONSE, run by Instituto Bernabeu at 4 sites 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 9 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 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 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?
Contact Anna Pitas, PhD (+34663926079, apitas@institutobernabeu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of retrieved oocytes (time frame: through study completion, usually will be evaluated on the last day of the treatment). The study lists 2 primary outcomes in all. 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 NCT05321511, which also lists 6 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 11 Apr 2022.