InfertilityPhase 4DUAL-TNCT04992468
Dual Trigger for Elective Fertility Preservation
A Phase 4 study testing Ovulation triggering with GnRH-a+rhCG and Ovulation triggering with GnRH-a in people with Infertility, run by Fundación Santiago Dexeus Font at 1 site in Spain.
Trial summary
The widespread availability of efficient contraception as well as women's increased education has led to childbearing postponement. Combined with the increased recognition of the concept of "ovarian aging", this has opened the Pandora´s box of EOC, which is currently considered a safe and cost-efficient approach among… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Ovulation triggering with GnRH-a+rhCG and Ovulation triggering with GnRH-a
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteSpain
- Study dates
- 5 Oct 2021to 25 Apr 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Able and willing to sign the Patient Consent Form and adhere to study visitation schedule
- antral follicle count (AFC) <20
- Anti-Mullerian hormone (AMH) ≤3ng/ml (AMH result of up to one year will be valid)
- Age >=18 and ≤40 years
- BMI >18 and <30 kg/m2
Who cannot join
- Medically indicated fertility preservation
- AFC ≥ 20
- Polycystic ovarian syndrome (PCOS) according to the Rotterdam criteria
- FSH ≥ 20
- History of untreated autoimmune, endocrine or metabolic disorders
- Contraindication for hormonal treatment
- Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dual Trigger vs.GnRH-a Trigger for Elective Fertility Preservation. A Randomized Controlled Trial
The widespread availability of efficient contraception as well as women's increased education has led to childbearing postponement. Combined with the increased recognition of the concept of "ovarian aging", this has opened the Pandora´s box of EOC, which is currently considered a safe and cost-efficient approach among assisted reproduction techniques.
Previous studies have shown that two main factors determine the CLBR after EOC: 1) patient's age at the time of oocyte banking, and 2) the number of oocytes retrieved. Therefore, measures aiming at increasing the oocyte yield, specially the number of mature oocytes retrieved, will maximize the success of this technique.
In the last few years, the dual trigger for final oocyte maturation has emerged has an approach that seems to improve both oocyte yield and quality when compared to the hCG trigger alone. Nowadays, the standard of care in EOC patients is final oocyte maturation with a single bolus of GnRH-a. Understanding the impact of the dual trigger on the number of MII oocytes retrieved in patients undergoing EOC will improve the treatment protocols and allow for a better patient counselling.
Read the detailed description
Elective oocyte cryopreservation (EOC) has been gaining increasing importance in the last few years, driven by the widespread information regarding the concept of 'age-related fertility decline', as well as the availability of efficient contraception and women's increasing educational and professional aspirations. Considering the similar clinical outcomes regarding live birth rate after vitrified-warmed and fresh oocytes and the proven cost-effectiveness of this approach, oocyte banking is now considered an efficient technique in assisted reproduction.
Previous studies have shown that both patient's age and the number of oocytes retrieved have a significant impact on the cumulative live birth rate (CLBR) in patients undergoing EOC, highlighting the importance of maximizing oocyte yield in these patients.
In all these former reports, final follicular maturation was triggered by one bolus of human chorionic gonadotropin (hCG) or, following recent trends in clinical practice, by a single bolus of Gonadotropin Releasing Hormone agonist (GnRH-a).
More recently, the concomitant administration of both GnRH-a and a bolus of HCG prior to oocyte retrieval (dual trigger) has been proposed as a new strategy for final follicular maturation, aiming to improve oocyte and embryo quality . When compared to HCG trigger, the dual trigger adds the more physiologic follicular stimulating hormone (FSH) and luteinizing hormone (LH) peak provided by GnRH-a. With this approach, several studies have reported an increase in the number of MII oocytes retrieved, as well as in the number of good quality embryos and improved pregnancy outcomes in different subpopulations of infertile patients.
Nowadays, the standard of care in patients undergoing a freeze-all approach, either for oocyte or embryo cryopreservation, is final follicular maturation with GnRH-a due to its more physiologic and shorter surge of both LH and FSH, terminating 24h after its onset, and reducing the risk of ovarian hyperstimulation syndrome (OHSS). So far, no study has compared the dual trigger approach to the use of a single bolus of GnRH-a. By adding HCG activity and, therefore, generating higher intracellular cyclic adenosine monophosphate (cAMP) accumulation, an amplification of the steroidogenic response of the pre-ovulatory follicle might be achieved with the dual trigger when compared to the GnRH-a trigger alone.
Therefore, the investigators set out to perform this randomized controlled trial aiming to compare, for the first time, the dual trigger and the GnRH-a trigger regarding the number of MII oocytes retrieved in patients undergoing EOC.
- Conditions
- Infertility
- Being tested
- Ovulation triggering with GnRH-a+rhCG, Ovulation triggering with GnRH-a
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovulation triggering with GnRH-a+rhCGDrug
recombinant follicle stimulating hormone (rFSH) 225-300 IU (Gonal-F®/Puregon®/ Ovaleap®/Rekovelle®) Micronized progesterone 200mg (Utrogestan®) Ovulation trigger: Triptorelin 0.2 mg (Decapeptyl®) + Recombinant human chorionic gonadotropin (rhCG) 250μg (Ovitrelle®)
Ovulation triggering with GnRH-aDrug
rFSH 225-300 IU (Gonal-F®/Puregon®/Ovaleap®/ Rekovelle®) Micronized progesterone 200mg (Utrogestan®) Ovulation trigger: Triptorelin 0.2 mg (Decapeptyl®)
| Study group | Role | What they receive |
|---|---|---|
| GnRH-a+rhCG | Experimental | Ovulation triggering with GnRH-a+rhCG Receives: Drug: Ovulation triggering with GnRH-a+rhCG |
| GnRH-a | Active comparator | Ovulation triggering with GnRH-a Receives: Drug: Ovulation triggering with GnRH-a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of mature oocytes (MIIs) retrieved
Measured: 7 -20 days from initiation of ovarian stimulation
Secondary outcomes (6)
Number of oocytes retrieved
Measured: 7 -20 days from initiation of ovarian stimulation
Change in Progesterone values
Measured: Day 1 of ovarian stimulation, Day of HCG/HCG+Decapeptyl administration and Day after HCG/HCG+Decapeptyl
Change in Estradiol values
Measured: Day 1 of ovarian stimulation, Day of HCG/HCG+Decapeptyl administration and Day after HCG/HCG+Decapeptyl
Change in FSH values
Measured: Day 1 of ovarian stimulation, Day of HCG/HCG+Decapeptyl administration and Day after HCG/HCG+Decapeptyl
Change in LH values
Measured: Day 1 of ovarian stimulation, Day of HCG/HCG+Decapeptyl administration and Day after HCG/HCG+Decapeptyl
Ovarian hyperstimulation syndrome (OHSS) (percent)
Measured: Until 15 days after the end of ovarian stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start5 Oct 2021
- Primary completion25 Apr 2023
- Study completion25 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Santiago Dexeus Font
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikolaos P Polyzos, MD PhD, Study chair, Hospital Universitari DexeusAna Neves, MD, Principal investigator, Hospital Universitari Dexeus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992468
- Sponsor's protocol ID
- FSD-PSE-2021-09
- Other IDs
- 2021-002467-22
- Acronym
- DUAL-T
- Status last verified
- Jul 2023
- First submitted
- 5 Jul 2021
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ovarian Stimulation TEGGO, Bosch E, Broer S, Griesinger G, Grynberg M, Humaidan P, Kolibianakis E, Kunicki M, La Marca A, Lainas G, Le Clef N, Massin N, Mastenbroek S, Polyzos N, Sunkara SK, Timeva T, Toyli M, Urbancsek J, Vermeulen N, Broekmans F. ESHRE guideline: ovarian stimulation for IVF/ICSIdagger. Hum Reprod Open. 2020 May 1;2020(2):hoaa009. doi: 10.1093/hropen/hoaa009. eCollection 2020.
PubMed 32395637Casarini L, Lispi M, Longobardi S, Milosa F, La Marca A, Tagliasacchi D, Pignatti E, Simoni M. LH and hCG action on the same receptor results in quantitatively and qualitatively different intracellular signalling. PLoS One. 2012;7(10):e46682. doi: 10.1371/journal.pone.0046682. Epub 2012 Oct 5.
PubMed 23071612Cobo A, Garcia-Velasco J, Domingo J, Pellicer A, Remohi J. Elective and Onco-fertility preservation: factors related to IVF outcomes. Hum Reprod. 2018 Dec 1;33(12):2222-2231. doi: 10.1093/humrep/dey321.
PubMed 30383235Cobo A, Garcia-Velasco JA, Coello A, Domingo J, Pellicer A, Remohi J. Oocyte vitrification as an efficient option for elective fertility preservation. Fertil Steril. 2016 Mar;105(3):755-764.e8. doi: 10.1016/j.fertnstert.2015.11.027. Epub 2015 Dec 10.
PubMed 26688429Devine K, Mumford SL, Goldman KN, Hodes-Wertz B, Druckenmiller S, Propst AM, Noyes N. Baby budgeting: oocyte cryopreservation in women delaying reproduction can reduce cost per live birth. Fertil Steril. 2015 Jun;103(6):1446-53.e1-2. doi: 10.1016/j.fertnstert.2015.02.029. Epub 2015 Mar 23.
PubMed 25813281Ding N, Liu X, Jian Q, Liang Z, Wang F. Dual trigger of final oocyte maturation with a combination of GnRH agonist and hCG versus a hCG alone trigger in GnRH antagonist cycle for in vitro fertilization: A Systematic Review and Meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2017 Nov;218:92-98. doi: 10.1016/j.ejogrb.2017.09.004. Epub 2017 Sep 14.
PubMed 28957685Doyle JO, Richter KS, Lim J, Stillman RJ, Graham JR, Tucker MJ. Successful elective and medically indicated oocyte vitrification and warming for autologous in vitro fertilization, with predicted birth probabilities for fertility preservation according to number of cryopreserved oocytes and age at retrieval. Fertil Steril. 2016 Feb;105(2):459-66.e2. doi: 10.1016/j.fertnstert.2015.10.026. Epub 2015 Nov 18.
PubMed 26604065Fauser BC, de Jong D, Olivennes F, Wramsby H, Tay C, Itskovitz-Eldor J, van Hooren HG. Endocrine profiles after triggering of final oocyte maturation with GnRH agonist after cotreatment with the GnRH antagonist ganirelix during ovarian hyperstimulation for in vitro fertilization. J Clin Endocrinol Metab. 2002 Feb;87(2):709-15. doi: 10.1210/jcem.87.2.8197.
PubMed 11836309Golan A, Weissman A. Symposium: Update on prediction and management of OHSS. A modern classification of OHSS. Reprod Biomed Online. 2009 Jul;19(1):28-32. doi: 10.1016/s1472-6483(10)60042-9.
PubMed 19573287Goldman RH, Racowsky C, Farland LV, Munne S, Ribustello L, Fox JH. Predicting the likelihood of live birth for elective oocyte cryopreservation: a counseling tool for physicians and patients. Hum Reprod. 2017 Apr 1;32(4):853-859. doi: 10.1093/humrep/dex008.
PubMed 28166330Griffin D, Feinn R, Engmann L, Nulsen J, Budinetz T, Benadiva C. Dual trigger with gonadotropin-releasing hormone agonist and standard dose human chorionic gonadotropin to improve oocyte maturity rates. Fertil Steril. 2014 Aug;102(2):405-9. doi: 10.1016/j.fertnstert.2014.04.028. Epub 2014 May 17.
PubMed 24842671Haas J, Bassil R, Samara N, Zilberberg E, Mehta C, Orvieto R, Casper RF. GnRH agonist and hCG (dual trigger) versus hCG trigger for final follicular maturation: a double-blinded, randomized controlled study. Hum Reprod. 2020 Jul 1;35(7):1648-1654. doi: 10.1093/humrep/deaa107.
PubMed 32563188Lin MH, Wu FS, Lee RK, Li SH, Lin SY, Hwu YM. Dual trigger with combination of gonadotropin-releasing hormone agonist and human chorionic gonadotropin significantly improves the live-birth rate for normal responders in GnRH-antagonist cycles. Fertil Steril. 2013 Nov;100(5):1296-302. doi: 10.1016/j.fertnstert.2013.07.1976. Epub 2013 Aug 28.
PubMed 23993928van Loendersloot LL, Moolenaar LM, Mol BW, Repping S, van der Veen F, Goddijn M. Expanding reproductive lifespan: a cost-effectiveness study on oocyte freezing. Hum Reprod. 2011 Nov;26(11):3054-60. doi: 10.1093/humrep/der284. Epub 2011 Sep 6.
PubMed 21896545Mills M, Rindfuss RR, McDonald P, te Velde E; ESHRE Reproduction and Society Task Force. Why do people postpone parenthood? Reasons and social policy incentives. Hum Reprod Update. 2011 Nov-Dec;17(6):848-60. doi: 10.1093/humupd/dmr026. Epub 2011 Jun 7.
PubMed 21652599
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Trigger vs.GnRH-a Trigger for Elective Fertility Preservation. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04992468
- Acronym / sponsor ID
- DUAL-T / FSD-PSE-2021-09
- Conditions
- Infertility
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Fundación Santiago Dexeus FontUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 5 Aug 2021 (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.
The widespread availability of efficient contraception as well as women's increased education has led to childbearing postponement. Combined with the increased recognition of the concept of "ovarian aging", this has opened the Pandora´s box of EOC, which is currently considered a safe and cost-efficient approach among assisted reproduction techniques.
Previous studies have shown that two main factors determine the CLBR after EOC: 1) patient's age at the time of oocyte banking, and 2) the number of oocytes retrieved. Therefore, measures aiming at increasing the oocyte yield, specially the number of mature oocytes retrieved, will maximize the success of this technique.
In the last few years, the dual trigger for final oocyte maturation has emerged has an approach that seems to improve both oocyte yield and quality when compared to the hCG trigger alone. Nowadays, the standard of care in EOC patients is final oocyte maturation with a single bolus of GnRH-a. Understanding the impact of the dual trigger on the number of MII oocytes retrieved in patients undergoing EOC will improve the treatment protocols and allow for a better patient counselling.
Detailed description
Elective oocyte cryopreservation (EOC) has been gaining increasing importance in the last few years, driven by the widespread information regarding the concept of 'age-related fertility decline', as well as the availability of efficient contraception and women's increasing educational and professional aspirations. Considering the similar clinical outcomes regarding live birth rate after vitrified-warmed and fresh oocytes and the proven cost-effectiveness of this approach, oocyte banking is now considered an efficient technique in assisted reproduction.
Previous studies have shown that both patient's age and the number of oocytes retrieved have a significant impact on the cumulative live birth rate (CLBR) in patients undergoing EOC, highlighting the importance of maximizing oocyte yield in these patients.
In all these former reports, final follicular maturation was triggered by one bolus of human chorionic gonadotropin (hCG) or, following recent trends in clinical practice, by a single bolus of Gonadotropin Releasing Hormone agonist (GnRH-a).
More recently, the concomitant administration of both GnRH-a and a bolus of HCG prior to oocyte retrieval (dual trigger) has been proposed as a new strategy for final follicular maturation, aiming to improve oocyte and embryo quality . When compared to HCG trigger, the dual trigger adds the more physiologic follicular stimulating hormone (FSH) and luteinizing hormone (LH) peak provided by GnRH-a. With this approach, several studies have reported an increase in the number of MII oocytes retrieved, as well as in the number of good quality embryos and improved pregnancy outcomes in different subpopulations of infertile patients.
Nowadays, the standard of care in patients undergoing a freeze-all approach, either for oocyte or embryo cryopreservation, is final follicular maturation with GnRH-a due to its more physiologic and shorter surge of both LH and FSH, terminating 24h after its onset, and reducing the risk of ovarian hyperstimulation syndrome (OHSS). So far, no study has compared the dual trigger approach to the use of a single bolus of GnRH-a. By adding HCG activity and, therefore, generating higher intracellular cyclic adenosine monophosphate (cAMP) accumulation, an amplification of the steroidogenic response of the pre-ovulatory follicle might be achieved with the dual trigger when compared to the GnRH-a trigger alone.
Therefore, the investigators set out to perform this randomized controlled trial aiming to compare, for the first time, the dual trigger and the GnRH-a trigger regarding the number of MII oocytes retrieved in patients undergoing EOC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GnRH-a+rhCG | Experimental | Drug: Ovulation triggering with GnRH-a+rhCGOvulation triggering with GnRH-a+rhCG |
| GnRH-a | Active comparator | Drug: Ovulation triggering with GnRH-aOvulation triggering with GnRH-a |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Able and willing to sign the Patient Consent Form and adhere to study visitation schedule
- antral follicle count (AFC) <20
- Anti-Mullerian hormone (AMH) ≤3ng/ml (AMH result of up to one year will be valid)
- Age >=18 and ≤40 years
- BMI >18 and <30 kg/m2
Key exclusion criteria (7 listed)
- Medically indicated fertility preservation
- AFC ≥ 20
- Polycystic ovarian syndrome (PCOS) according to the Rotterdam criteria
- FSH ≥ 20
- History of untreated autoimmune, endocrine or metabolic disorders
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 |
|---|---|---|
| Ovulation triggering with GnRH-a+rhCGrecombinant follicle stimulating hormone (rFSH) 225-300 IU (Gonal-F®/Puregon®/ Ovaleap®/Rekovelle®) Micronized progesterone 200mg (Utrogestan®) Ovulation trigger: Triptorelin 0.2 mg (Decapeptyl®) + Recombinant human chorionic gonadotropin (rhCG) 250μg (Ovitrelle®) | Drug | GnRH-a+rhCG |
| Ovulation triggering with GnRH-arFSH 225-300 IU (Gonal-F®/Puregon®/Ovaleap®/ Rekovelle®) Micronized progesterone 200mg (Utrogestan®) Ovulation trigger: Triptorelin 0.2 mg (Decapeptyl®) | Drug | GnRH-a |
Primary outcome
Number of mature oocytes (MIIs) retrieved
Time frame: 7 -20 days from initiation of ovarian stimulation
6 secondary outcomes
Number of oocytes retrieved
Time frame: 7 -20 days from initiation of ovarian stimulation
Change in Progesterone values
Time frame: Day 1 of ovarian stimulation, Day of HCG/HCG+Decapeptyl administration and Day after HCG/HCG+Decapeptyl
Change in Estradiol values
Time frame: Day 1 of ovarian stimulation, Day of HCG/HCG+Decapeptyl administration and Day after HCG/HCG+Decapeptyl
Change in FSH values
Time frame: Day 1 of ovarian stimulation, Day of HCG/HCG+Decapeptyl administration and Day after HCG/HCG+Decapeptyl
Change in LH values
Time frame: Day 1 of ovarian stimulation, Day of HCG/HCG+Decapeptyl administration and Day after HCG/HCG+Decapeptyl
Ovarian hyperstimulation syndrome (OHSS) (percent)
Time frame: Until 15 days after the end of ovarian stimulation
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 25 Jul 2023.
- Background: PubMed 32395637Ovarian Stimulation TEGGO, Bosch E, Broer S, Griesinger G, Grynberg M, Humaidan P, Kolibianakis E, Kunicki M, La Marca A, Lainas G, Le Clef N, Massin N, Mastenbroek S, Polyzos N, Sunkara SK, Timeva T, Toyli M, Urbancsek J, Vermeulen N, Broekmans F. ESHRE guideline: ovarian stimulation for IVF/ICSIdagger. Hum Reprod Open. 2020 May 1;2020(2):hoaa009. doi: 10.1093/hropen/hoaa009. eCollection 2020.
- Background: PubMed 23071612Casarini L, Lispi M, Longobardi S, Milosa F, La Marca A, Tagliasacchi D, Pignatti E, Simoni M. LH and hCG action on the same receptor results in quantitatively and qualitatively different intracellular signalling. PLoS One. 2012;7(10):e46682. doi: 10.1371/journal.pone.0046682. Epub 2012 Oct 5.
- Background: PubMed 30383235Cobo A, Garcia-Velasco J, Domingo J, Pellicer A, Remohi J. Elective and Onco-fertility preservation: factors related to IVF outcomes. Hum Reprod. 2018 Dec 1;33(12):2222-2231. doi: 10.1093/humrep/dey321.
- Background: PubMed 26688429Cobo A, Garcia-Velasco JA, Coello A, Domingo J, Pellicer A, Remohi J. Oocyte vitrification as an efficient option for elective fertility preservation. Fertil Steril. 2016 Mar;105(3):755-764.e8. doi: 10.1016/j.fertnstert.2015.11.027. Epub 2015 Dec 10.
- Background: PubMed 25813281Devine K, Mumford SL, Goldman KN, Hodes-Wertz B, Druckenmiller S, Propst AM, Noyes N. Baby budgeting: oocyte cryopreservation in women delaying reproduction can reduce cost per live birth. Fertil Steril. 2015 Jun;103(6):1446-53.e1-2. doi: 10.1016/j.fertnstert.2015.02.029. Epub 2015 Mar 23.
- Background: PubMed 28957685Ding N, Liu X, Jian Q, Liang Z, Wang F. Dual trigger of final oocyte maturation with a combination of GnRH agonist and hCG versus a hCG alone trigger in GnRH antagonist cycle for in vitro fertilization: A Systematic Review and Meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2017 Nov;218:92-98. doi: 10.1016/j.ejogrb.2017.09.004. Epub 2017 Sep 14.
- Background: PubMed 26604065Doyle JO, Richter KS, Lim J, Stillman RJ, Graham JR, Tucker MJ. Successful elective and medically indicated oocyte vitrification and warming for autologous in vitro fertilization, with predicted birth probabilities for fertility preservation according to number of cryopreserved oocytes and age at retrieval. Fertil Steril. 2016 Feb;105(2):459-66.e2. doi: 10.1016/j.fertnstert.2015.10.026. Epub 2015 Nov 18.
- Background: PubMed 11836309Fauser BC, de Jong D, Olivennes F, Wramsby H, Tay C, Itskovitz-Eldor J, van Hooren HG. Endocrine profiles after triggering of final oocyte maturation with GnRH agonist after cotreatment with the GnRH antagonist ganirelix during ovarian hyperstimulation for in vitro fertilization. J Clin Endocrinol Metab. 2002 Feb;87(2):709-15. doi: 10.1210/jcem.87.2.8197.
- Background: PubMed 19573287Golan A, Weissman A. Symposium: Update on prediction and management of OHSS. A modern classification of OHSS. Reprod Biomed Online. 2009 Jul;19(1):28-32. doi: 10.1016/s1472-6483(10)60042-9.
- Background: PubMed 28166330Goldman RH, Racowsky C, Farland LV, Munne S, Ribustello L, Fox JH. Predicting the likelihood of live birth for elective oocyte cryopreservation: a counseling tool for physicians and patients. Hum Reprod. 2017 Apr 1;32(4):853-859. doi: 10.1093/humrep/dex008.
- Background: PubMed 24842671Griffin D, Feinn R, Engmann L, Nulsen J, Budinetz T, Benadiva C. Dual trigger with gonadotropin-releasing hormone agonist and standard dose human chorionic gonadotropin to improve oocyte maturity rates. Fertil Steril. 2014 Aug;102(2):405-9. doi: 10.1016/j.fertnstert.2014.04.028. Epub 2014 May 17.
- Background: PubMed 32563188Haas J, Bassil R, Samara N, Zilberberg E, Mehta C, Orvieto R, Casper RF. GnRH agonist and hCG (dual trigger) versus hCG trigger for final follicular maturation: a double-blinded, randomized controlled study. Hum Reprod. 2020 Jul 1;35(7):1648-1654. doi: 10.1093/humrep/deaa107.
- Department of Obstetrics, Gynaecology and Reproduction Hospital Universitari Quiron DexeusLink provided by the sponsor.
- 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.
Nikolaos P Polyzos, MD PhD study chair
Hospital Universitari Dexeus
Ana Neves, MD principal investigator
Hospital Universitari Dexeus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ovulation triggering with GnRH-a+rhCG and Ovulation triggering with GnRH-a in people with Infertility, run by Fundación Santiago Dexeus Font 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 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 25 Jul 2023. 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 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?
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 (MIIs) retrieved (time frame: 7 -20 days from initiation of ovarian stimulation). 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 NCT04992468, which also lists 18 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 25 Jul 2023.