Fertility Preservation
Conditions
Keywords
IVF, GnRH agonist
Brief summary
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.
Detailed description
Women meeting the inclusion criteria will be randomised to receive triggering for final oocyte maturation with 200 micrograms of subcutaneous triptorelin (control group) or 800 micrograms of intranasal nafarelin (experimental group). The primary outcome is the number of mature (metaphase 2 (MII)) oocytes collected. The study has been designed with a non-inferiority limit of a difference of 2 mature oocytes, with 80% power and two-sided alpha of 0.05.
Interventions
DRUGSubcutaneous Triptorelin
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.
DRUGIntranasal nafarelin
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.
Sponsors
Fundacion Dexeus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Allergy or hypersensitivity to either of the study drugs * Hypopituitarism * Known pituitary tumour * Contraindication to intranasal medication administration * Previous poor response to agonist trigger
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of MII (metaphase 2) oocyte retrieved | Until study completion - average of 10-20 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total number of oocytes retrieved | Until study completion - average of 10-20 days | — |
| Incidence of ovarian hyperstimulation syndrome | Until study completion - average of 10-20 days | — |
| Serum FSH levels 10-14 hours after trigger | 1 day after study medication | — |
| Serum LH levels at time of oocyte collection | 2 days after study medication | — |
| Serum FSH levels at time of oocyte collection | 2 days after study medication | — |
| Serum progesterone levels at time of oocyte collection | 2 days after study medication | — |
| Participant-reported pain | Until study completion - average of 10-20 days | . Participant-reported pain (measured using a visual analogue scale from 0 (no pain) to 10 (severe pain)) |
| Medication ease of use | Until study completion - average of 10-20 days | Medication ease of use (measured using a visual analogue scale from 0 (very easy) to 10 (very difficult)) |
| Medication preference | Until study completion - average of 10-20 days | Medication preference (measured using a 5-point Likert scale from (a) "I would strongly prefer the nasal spray" to (e) "I would strongly prefer the injection") |
| Adverse events | Until study completion - average of 10-20 days | — |
Countries
Spain
Contacts
CONTACTNikolaos P Polyzos, MD, PhD
CONTACTIgnacio Rodríguez, MSc
PRINCIPAL_INVESTIGATORNikolaos P Polyzos, MD, PhD
Dexeus Fertility
Outcome results
None listed