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Intranasal Nafarelin For Triggering Oocyte Maturation

ConditionFertility Preservation
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorFundacion Dexeus

About this trial

This is a non-inferiority randomised, controlled clinical trial comparing subcutaneous triptorelin to intranasal nafarelin for the final maturation of oocytes in women undergoing fertility preservation cycles with oocyte cryopreservation undergoing ovarian stimulation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women undergoing fertility preservation cycles with oocyte cryopreservation

Undergoing a progesterone-primed ovarian stimulation cycle (PPOS) with any commercially available gonadotropin preparation(s)

BMI 18 - 30 kg/m2

Disqualifiers

Allergy or hypersensitivity to either of the study drugs

Hypopituitarism

Known pituitary tumour

Contraindication to intranasal medication administration

Trial design

Design model

Parallel

Treatments tested in this trial

  • Subcutaneous Triptorelin

    Drug

    Women undergoing fertility preservation will undergo progesterone-primed ovarian stimulation according to the standard operating protocol for the clinical unit.. For participants taking oral contraceptives before the treatment, the pill-free interval before starting ovarian stimulation will be 5 days. Participants will administer exogenous gonadotropins (recombinant or urinary), along with 200mg oral micronized progesterone per day for pituitary suppression. Participants using any commercially available gonadotropin preparation will be eligible for inclusion. Once 3 follicles ≥18mm are observed, participants will be randomised to one of the study arms. n the control group, 200 mcg subcutaneous triptorelin will be administered 34-36 hours prior to planned oocyte collection.

  • Intranasal nafarelin

    Drug

    Women undergoing fertility preservation will undergo progesterone-primed ovarian stimulation according to the standard operating protocol for the clinical unit. For participants taking oral contraceptives before the treatment, the pill-free interval before starting ovarian stimulation will be 5 days. Participants will administer exogenous gonadotropins (recombinant or urinary), along with 200mg oral micronized progesterone per day for pituitary suppression. Participants using any commercially available gonadotropin preparation will be eligible for inclusion. Once 3 follicles ≥18mm are observed, participants will be randomised to one of the study arms.In the experimental group, 800 mcg intranasal nafarelin will be administered 34-36 hours prior to planned oocyte collection.

Treatment groups

154 Participants
are divided into 2 treatment groups
Group A: Subcutaneous TriptorelinActive comparator 1 intervention
Group B: Intranasal NafarelinActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of MII (metaphase 2) oocyte retrieved

Time frame
Until study completion - average of 10-20 days

Secondary outcomes

1

Total number of oocytes retrieved

Time frame
Until study completion - average of 10-20 days
2

Incidence of ovarian hyperstimulation syndrome

Time frame
Until study completion - average of 10-20 days
3

Serum FSH levels 10-14 hours after trigger

Time frame
1 day after study medication
4

Serum LH levels at time of oocyte collection

Time frame
2 days after study medication

Other outcomes

Sponsors and contacts

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Fundacion Dexeus

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: