Comparision of three different methods for egg maturation, in the double stimulation protocol, in the low responder patients.

Dual Stim comparison of triggers for the second egg collection: Is there any advantage using 3 different methods of trigger for the second egg collection in Dual Stim cycles in predicted low responders?

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001225-43-ES

Enrollment

165

Registered

2021-09-02

Start date

2021-06-14

Completion date

Unknown

Last updated

2021-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with predictive indicators of low ovarian response (according to Poseidon criteria) and who undergo double ovarian stimulation (Dual Stim).

Interventions

Trade Name: Ovitrelle 250 micrograms solution for injection in pre-filled pen. Product Name: Ovitrelle 250 micrograms solution for injection in pre-filled pen Pharmaceutical Form: Solution for inject

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age: less than or equal to 43 years old 2. Body Mass Index (BMI): =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Non-compliance with instructions and/or non-formalization of consents or legal requirements for IVF. 2. Concurrent participation in another study

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare the efficacy of Double Trigger (Ovitrelle® + Decapeptyl®) vs. hCG-rec (Ovitrelle®) or aGnRG (Decapeptyl®) isolated in terms of number of total and mature oocytes obtained in the second cycle of a Dual Stim sequence.;Secondary Objective: - To analyze the number of total and mature oocytes obtained in the 1st and 2nd cycle of the Dual Stim sequence. - To analyze the number of blastocysts per patient. - To analyze the number of blastocysts vitrified per patient after the 1st and 2nd stimulation. - To analyze the implantation rate, clinical pregnancy, clinical miscarriage and biochemical miscarriage. - To analyze the newborn rate.;Primary end point(s): To compare the number of total oocytes and MII in patients with probable low ovarian response (Poseidon classification group 3 and 4) obtained in the 2nd cycle of a Dual Stim sequence applying in this Dual Trigger (aGnRH and hCG-rec together) vs. aGnRH or hCG-rec alone.;Timepoint(s) of evaluation of this end point: Egg collection of the second ovarian stimulation in the Dual Stim protocol.	—

Measure

Time frame

Main Objective: To compare the efficacy of Double Trigger (Ovitrelle® + Decapeptyl®) vs. hCG-rec (Ovitrelle®) or aGnRG (Decapeptyl®) isolated in terms of number of total and mature oocytes obtained in the second cycle of a Dual Stim sequence.;Secondary Objective: - To analyze the number of total and mature oocytes obtained in the 1st and 2nd cycle of the Dual Stim sequence. - To analyze the number of blastocysts per patient. - To analyze the number of blastocysts vitrified per patient after the 1st and 2nd stimulation. - To analyze the implantation rate, clinical pregnancy, clinical miscarriage and biochemical miscarriage. - To analyze the newborn rate.;Primary end point(s): To compare the number of total oocytes and MII in patients with probable low ovarian response (Poseidon classification group 3 and 4) obtained in the 2nd cycle of a Dual Stim sequence applying in this Dual Trigger (aGnRH and hCG-rec together) vs. aGnRH or hCG-rec alone.;Timepoint(s) of evaluation of this end point: Egg collection of the second ovarian stimulation in the Dual Stim protocol.

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Secondary

Measure	Time frame
Secondary end point(s): 1. To analyze the number of total oocytes and MII obtained in the 1st and 2nd cycle of the Dual Stim sequence. 2. To analyze the number of blastocysts per patient. 3. To analyze the number of blastocysts vitrified per patient after the 1st and 2nd stimulation. 4. To analyze the implantation rate, clinical pregnancy, clinical miscarriage and biochemical miscarriage. 5. To analyze the newborn rate;Timepoint(s) of evaluation of this end point: 1. Egg collection of the second ovarian stimulation in the Dual Stim protocol. 2, 3. Five to six days after the second egg collection. 4. up till 9 months after the second egg collection. 5. From 9 to 12 months after the second egg collection.	—

Measure

Time frame

Secondary end point(s): 1. To analyze the number of total oocytes and MII obtained in the 1st and 2nd cycle of the Dual Stim sequence. 2. To analyze the number of blastocysts per patient. 3. To analyze the number of blastocysts vitrified per patient after the 1st and 2nd stimulation. 4. To analyze the implantation rate, clinical pregnancy, clinical miscarriage and biochemical miscarriage. 5. To analyze the newborn rate;Timepoint(s) of evaluation of this end point: 1. Egg collection of the second ovarian stimulation in the Dual Stim protocol. 2, 3. Five to six days after the second egg collection. 4. up till 9 months after the second egg collection. 5. From 9 to 12 months after the second egg collection.

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Countries

Spain

Contacts

Public ContactInstituto Bernabeu

Instituto Bernabeu

apitas@institutobernabeu.com0034965154000

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026