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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
Sponsor:
Information provided by (Responsible Party):
Institut Universitari Dexeus ( Fundación Santiago Dexeus Font )

Brief 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 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

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: GnRH-a+rhCG
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®)




Primary Outcome Measures :
  1. Number of mature oocytes (MIIs) retrieved [ Time Frame: 7 -20 days from initiation of ovarian stimulation ]

Secondary Outcome Measures :
  1. Number of oocytes retrieved [ Time Frame: 7 -20 days from initiation of ovarian stimulation ]
  2. Change in Progesterone values [ Time Frame: Day 1 of ovarian stimulation, Day of HCG/HCG+Decapeptyl administration and Day after HCG/HCG+Decapeptyl ]
  3. Change in Estradiol values [ Time Frame: Day 1 of ovarian stimulation, Day of HCG/HCG+Decapeptyl administration and Day after HCG/HCG+Decapeptyl ]
  4. Change in FSH values [ Time Frame: Day 1 of ovarian stimulation, Day of HCG/HCG+Decapeptyl administration and Day after HCG/HCG+Decapeptyl ]
  5. Change in LH values [ Time Frame: Day 1 of ovarian stimulation, Day of HCG/HCG+Decapeptyl administration and Day after HCG/HCG+Decapeptyl ]
  6. Ovarian hyperstimulation syndrome (OHSS) (percent) [ Time Frame: Until 15 days after the end of ovarian stimulation ]

Other Outcome Measures:
  1. Incidence of adverse events and serious adverse events [ Time Frame: Until 15 days after the end of ovarian stimulation ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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).

Information from the National Library of Medicine

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


Contacts
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Contact: Nikolaos P Polyzos, MD PhD 0034932274700 nikpol@dexeus.com
Contact: Ignacio Rodríguez, MSc 0034932274700 nacrod@dexeus.com

Locations
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Spain
Hospital Universitario Quiron Dexeus Recruiting
Barcelona, Spain, 08028
Contact: Nikolaos P Polyzos, MD PhD    0034932274700    nikpol@dexeus.com   
Contact: Ignacio Rodriguez, MSc    0034932274700    nacrod@dexeus.com   
Principal Investigator: Ana Neves, MD         
Sponsors and Collaborators
Fundación Santiago Dexeus Font
Investigators
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Study Chair: Nikolaos P Polyzos, MD PhD Hospital Universitari Dexeus
Principal Investigator: Ana Neves, MD Hospital Universitari Dexeus
Additional Information:
Publications:

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Responsible Party: Fundación Santiago Dexeus Font
ClinicalTrials.gov Identifier: NCT04992468    
Other Study ID Numbers: FSD-PSE-2021-09
2021-002467-22 ( EudraCT Number )
First Posted: August 5, 2021    Key Record Dates
Last Update Posted: October 7, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Prolactin Release-Inhibiting Factors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs