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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-516621-31-00 | EU Trial (CTIS) Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subcutaneous Triptorelin | Active Comparator | 200 mcg subcutaneous triptorelin 34-36 hours prior to planned oocyte collection |
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| Intranasal Nafarelin | Active Comparator | 800 mcg intranasal nafarelin 36 hours prior to planned oocyte collection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of MII (metaphase 2) oocyte retrieved | Until study completion - average of 10-20 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nikolaos P Polyzos, MD, PhD | Contact | 0034932274700 | nikpol@dexeus.com | |
| Ignacio Rodríguez, MSc | Contact | 0034932274700 | 22029 | nacrod@dexeus.com |
| Name | Affiliation | Role |
|---|---|---|
| Nikolaos P Polyzos, MD, PhD | Dexeus Fertility | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dexeus Mujer Sabadell | Sabadell | Barcelona | 08203 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25358904 | Background | Youssef MA, Van der Veen F, Al-Inany HG, Mochtar MH, Griesinger G, Nagi Mohesen M, Aboulfoutouh I, van Wely M. Gonadotropin-releasing hormone agonist versus HCG for oocyte triggering in antagonist-assisted reproductive technology. Cochrane Database Syst Rev. 2014 Oct 31;2014(10):CD008046. doi: 10.1002/14651858.CD008046.pub4. | |
| Background | V. Donno, A. R. Neves, S. Garcia Martinez, N. P. Polyzos. O-074 Dual trigger is not superior to GnRH Agonist alone for final oocyte maturation in elective fertility preservation. A Randomized Controlled Trial. Hum Reprod. 2024;39(Supp 1). | ||
| Background | Davenport MJ, MacLachlan VB, Vollenhoven BJ, Talmor AJ, Healey M. How we trigger matters: intranasal GnRH-agonist trigger may reduce oocyte maturation compared to subcutaneous administration in ICSI cycles. Fertility and Sterility. 2019 | ||
| Label | URL |
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| Related Info | View source |
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| 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. |
|
| 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 | . Participant-reported pain (measured using a visual analogue scale from 0 (no pain) to 10 (severe pain)) | Until study completion - average of 10-20 days |
| Medication ease of use | Medication ease of use (measured using a visual analogue scale from 0 (very easy) to 10 (very difficult)) | Until study completion - average of 10-20 days |
| Medication preference | 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") | Until study completion - average of 10-20 days |
| Adverse events | Until study completion - average of 10-20 days |
| Dexeus Mujer Sant Cugat | Sant Cugat del Vallès | Barcelona | 08190 | Spain |
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| Dexeus Mujer Reus | Reus | Tarragona | 43202 | Spain |
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| Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus | Barcelona | 08037 | Spain |
| Dexeus Mujer Tarragona | Tarragona | 43206 | Spain |
|
| Background |
| Bar Hava I, Yafee H, Omer Y, Humaidan P, Ganer Herman H. GnRHa for trigger and luteal phase support in natural cycle frozen embryo transfer - A proof of concept study. Reprod Biol. 2020 Sep;20(3):282-287. doi: 10.1016/j.repbio.2020.07.009. Epub 2020 Jul 30. |
| 27114332 | Background | Bar-Hava I, Mizrachi Y, Karfunkel-Doron D, Omer Y, Sheena L, Carmon N, Ben-David G. Intranasal gonadotropin-releasing hormone agonist (GnRHa) for luteal-phase support following GnRHa triggering, a novel approach to avoid ovarian hyperstimulation syndrome in high responders. Fertil Steril. 2016 Aug;106(2):330-3. doi: 10.1016/j.fertnstert.2016.04.004. Epub 2016 Apr 22. |
| 19573287 | Background | Golan A, Weissman A. Symposium: Update on prediction and management of OHSS. A modern classification of OHSS. Reprod Biomed Online. 2009 Jul;19(1):28-32. doi: 10.1016/s1472-6483(10)60042-9. |