Infertility, Female Clinical Trial
Official title:
Comparación de Dos Modelos de PPOS Para supresión Hipofisaria en Ciclos de estimulación ovárica, Desogestrel vs Medroxiprogesterona
The scarcity of evidence regarding the interchangeable use of different progestogens poses challenges, particularly in international egg donation and fertility preservation programs where standardizing protocols is crucial for achieving consistent efficacy, efficiency, and safety outcomes. Consequently, there's a pressing need for clinical studies to assess the effects of various progestogens on clinical outcomes in controlled ovarian hyperstimulation cycles. This study, a pioneering effort, aims to compare the effects of two progestogens on oocyte performance, safety, and efficiency in an egg donation program involving young, healthy, normo-responding patients.
Status | Not yet recruiting |
Enrollment | 210 |
Est. completion date | December 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 34 Years |
Eligibility | Inclusion Criteria: - BMI of 18-29,9 kg/m2 - Ultrasound count of antral follicles prior to COH = 12 follicles - Meeting the criteria for inclusion in the egg donation program - Normal karyotype and no active sexually transmitted diseases - No use of combined hormonal contraceptives one month before COH Exclusion Criteria: - Patients excluded from the egg donation program - Untreated sexually transmitted diseases, positive serology for HBV, HIV, HCV - Blood disorders, neurodegenerative/psychiatric diseases, carriers of X-linked genetic diseases, oncological diseases, endometriosis. - Oligomenorrhea (<1 menstrual cycle in 3 months) - Use of combined hormonal contraceptives before COH |
Country | Name | City | State |
---|---|---|---|
Spain | NextFertility | Valencia | Comunidad Valenciana |
Lead Sponsor | Collaborator |
---|---|
NextFertility | SINAE SL |
Spain,
Begueria R, Garcia D, Vassena R, Rodriguez A. Medroxyprogesterone acetate versus ganirelix in oocyte donation: a randomized controlled trial. Hum Reprod. 2019 May 1;34(5):872-880. doi: 10.1093/humrep/dez034. — View Citation
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Kazemi A, Ramezanzadeh F, Nasr-Esfahani MH. The relations between dietary antioxidant vitamins intake and oxidative stress in follicular fluid and ART outcomes. Iran J Reprod Med. 2015 Sep;13(9):533-40. — View Citation
La Marca A, Capuzzo M. Use of progestins to inhibit spontaneous ovulation during ovarian stimulation: the beginning of a new era? Reprod Biomed Online. 2019 Aug;39(2):321-331. doi: 10.1016/j.rbmo.2019.03.212. Epub 2019 Mar 29. — View Citation
Martinez F, Rodriguez-Purata J, Beatriz Rodriguez D, Clua E, Rodriguez I, Coroleu B. Desogestrel versus antagonist injections for LH suppression in oocyte donation cycles: a crossover study. Gynecol Endocrinol. 2019 Oct;35(10):878-883. doi: 10.1080/09513590.2019.1604661. Epub 2019 May 7. — View Citation
Martinez F, Rodriguez-Purata J, Clua E, Garcia S, Coroleu B, Polyzos N. Ovarian response in oocyte donation cycles under LH suppression with GnRH antagonist or desogestrel progestin: retrospective and comparative study. Gynecol Endocrinol. 2019 Oct;35(10):884-889. doi: 10.1080/09513590.2019.1604662. Epub 2019 May 12. — View Citation
Massin N. New stimulation regimens: endogenous and exogenous progesterone use to block the LH surge during ovarian stimulation for IVF. Hum Reprod Update. 2017 Mar 1;23(2):211-220. doi: 10.1093/humupd/dmw047. — View Citation
Mikkelsen AL, Lindenberg S. Morphology of in-vitro matured oocytes: impact on fertility potential and embryo quality. Hum Reprod. 2001 Aug;16(8):1714-8. doi: 10.1093/humrep/16.8.1714. — View Citation
Phillips A, Hahn DW, Klimek S, McGuire JL. A comparison of the potencies and activities of progestogens used in contraceptives. Contraception. 1987 Aug;36(2):181-92. doi: 10.1016/0010-7824(87)90013-8. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total number of oocytes retrieved from follicular puncture | The total number of oocytes retrieved from the follicular puncture shall be counted. | 5 months | |
Primary | Number of mature oocytes (MII) retrieved from follicular puncture | The number of mature oocytes (MII) recovered from the follicular puncture shall be counted. | 5 months | |
Secondary | Oocyte quality variables | Oocyte morphology will be assessed following the standard grading system established in Next Fertility, according to the criteria mentioned above. | 5 months | |
Secondary | Ovarian sensitivity index (OSI | total dose of gonadotrophin used/total number of MII oocytes obtained) x 1000 | 5 months | |
Secondary | Follicles | Number of basal antral follicles of each size at the time of starting COH, Total number of follicles on the day of the second control and Number of follicles at the time of administering the trigger. | 5 months |
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