Dual Trigger for Elective Fertility Preservation (DUAL-T)
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|ClinicalTrials.gov Identifier: NCT04992468|
Recruitment Status : Recruiting
First Posted : August 5, 2021
Last Update Posted : October 7, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Infertility||Drug: Ovulation triggering with GnRH-a+rhCG Drug: Ovulation triggering with GnRH-a||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Dual Trigger vs.GnRH-a Trigger for Elective Fertility Preservation. A Randomized Controlled Trial|
|Actual Study Start Date :||October 5, 2021|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||December 2023|
Ovulation triggering with GnRH-a+rhCG
Drug: Ovulation triggering with GnRH-a+rhCG
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®)
Active Comparator: GnRH-a
Ovulation triggering with GnRH-a
Drug: Ovulation triggering with GnRH-a
rFSH 225-300 IU (Gonal-F®/Puregon®/Ovaleap®/ Rekovelle®) Micronized progesterone 200mg (Utrogestan®) Ovulation trigger: Triptorelin 0.2 mg (Decapeptyl®)
- Number of mature oocytes (MIIs) retrieved [ Time Frame: 7 -20 days from initiation of ovarian stimulation ]
- 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 ]
- Incidence of adverse events and serious adverse events [ Time Frame: Until 15 days after the end of ovarian stimulation ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04992468
|Contact: Nikolaos P Polyzos, MD PhDfirstname.lastname@example.org|
|Contact: Ignacio Rodríguez, MScemail@example.com|
|Study Chair:||Nikolaos P Polyzos, MD PhD||Hospital Universitari Dexeus|
|Principal Investigator:||Ana Neves, MD||Hospital Universitari Dexeus|