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Trial · Interventional

CompletedPhase 4Registry data

Dual Trigger for Elective Fertility Preservation

Short name DUAL-T

NCTNCT04992468 (opens ClinicalTrials.gov in a new tab)Other idFSD-PSE-2021-09Other id2021-002467-22
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Triptorelin (Trelstar, Decapeptyl), does not test it. It appears in the description.
  • Names hCG (human chorionic gonadotropin), does not test it. It appears in the summary.

Overview

Status
Completed
Phase
Phase 4
Enrollment
136 participants (actual)
Sponsor
Fundación Santiago Dexeus Font · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Spain

Start
5 Oct 2021
Primary completion
25 Apr 2023
Completion
25 Apr 2023
First posted
5 Aug 2021
Last update posted
25 Jul 2023
Conditions
Infertility

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2021202220232024
  1. Ph 4

    DUAL-T

    NCT04992468

    5 Oct 2021 to 25 Apr 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Ovulation triggering with GnRH-a+rhCGDrug
  • Ovulation triggering with GnRH-aDrug

Arms2

  • Experimental

    GnRH-a+rhCG

    Ovulation triggering with GnRH-a+rhCG

  • Active comparator

    GnRH-a

    Ovulation triggering with GnRH-a

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of mature oocytes (MIIs) retrieved

    Time frame · 7 -20 days from initiation of ovarian stimulation

Secondary outcomes(6)

  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Observational study · 2013

4 results

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.

Lin et al. 2013Fertility and sterilitycited by 110

PMID 23993928DOI 10.1016/j.fertnstert.2013.07.1976PUB-23993928

Full text at the publisher4 results
Publisher pageSee results (4)

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 40 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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).

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