Infertility Clinical Trial
Official title:
Impact of FSH Dosage During Ovarian Stimulation for IVF/ICSI on the Expression of FSH- and LH-receptors in Granulosa Cells
To study the influence of different daily rec-FSH dosages (150 IU versus 300 IU), performed in the same patient in consecutive cycles, on the relation between FSH- and LH-receptors of the granulosa cells of the growing follicle.
Status | Recruiting |
Enrollment | 10 |
Est. completion date | January 30, 2024 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 38 Years |
Eligibility | Inclusion Criteria: - Desire to perform oocyte freezing for social fertility preservation, age 18 - 38 years - BMI of 18-32 kg/m2 - Regular menstrual cycles with a length of 24-35 days - Anti-Muellerian-Hormone levels between 1.3 - 6.25 ng/ml (Ferraretti and Gianaroli, 2014; Calzada et al., 2019) Exclusion Criteria: - Occurrence of ovarian hyperstimulation syndrome (OHSS) - Occurrence of poor ovarian response (AFC < 5 and AMH < 0,5ng/ml) in previous ovarian stimulation treatment (20) - Polycystic ovary syndrome (PCOS) (21) |
Country | Name | City | State |
---|---|---|---|
United Arab Emirates | ART Fertility Clinics LLC | Abu Dhabi |
Lead Sponsor | Collaborator |
---|---|
ART Fertility Clinics LLC | Organon and Co |
United Arab Emirates,
Baker VL, Brown MB, Luke B, Smith GW, Ireland JJ. Gonadotropin dose is negatively correlated with live birth rate: analysis of more than 650,000 assisted reproductive technology cycles. Fertil Steril. 2015 Nov;104(5):1145-52.e1-5. doi: 10.1016/j.fertnstert.2015.07.1151. Epub 2015 Aug 18. — View Citation
Bosch E, Valencia I, Escudero E, Crespo J, Simon C, Remohi J, Pellicer A. Premature luteinization during gonadotropin-releasing hormone antagonist cycles and its relationship with in vitro fertilization outcome. Fertil Steril. 2003 Dec;80(6):1444-9. doi: 10.1016/j.fertnstert.2003.07.002. — View Citation
Calzada M, Lopez N, Noguera JA, Mendiola J, Hernandez AI, Corbalan S, Sanchez M, Torres AM. AMH in combination with SHBG for the diagnosis of polycystic ovary syndrome. J Obstet Gynaecol. 2019 Nov;39(8):1130-1136. doi: 10.1080/01443615.2019.1587604. Epub 2019 Jun 17. — View Citation
Erickson GF, Wang C, Hsueh AJ. FSH induction of functional LH receptors in granulosa cells cultured in a chemically defined medium. Nature. 1979 May 24;279(5711):336-8. doi: 10.1038/279336a0. No abstract available. — View Citation
Fauser BC. Towards the global coverage of a unified registry of IVF outcomes. Reprod Biomed Online. 2019 Feb;38(2):133-137. doi: 10.1016/j.rbmo.2018.12.001. Epub 2018 Dec 14. No abstract available. — View Citation
Ferraretti AP, Gianaroli L. The Bologna criteria for the definition of poor ovarian responders: is there a need for revision? Hum Reprod. 2014 Sep;29(9):1842-5. doi: 10.1093/humrep/deu139. Epub 2014 Jul 9. — View Citation
Filicori M, Cognigni GE, Gamberini E, Parmegiani L, Troilo E, Roset B. Efficacy of low-dose human chorionic gonadotropin alone to complete controlled ovarian stimulation. Fertil Steril. 2005 Aug;84(2):394-401. doi: 10.1016/j.fertnstert.2005.02.036. — View Citation
Huang B, Ren X, Wu L, Zhu L, Xu B, Li Y, Ai J, Jin L. Elevated Progesterone Levels on the Day of Oocyte Maturation May Affect Top Quality Embryo IVF Cycles. PLoS One. 2016 Jan 8;11(1):e0145895. doi: 10.1371/journal.pone.0145895. eCollection 2016. — View Citation
Jeppesen JV, Kristensen SG, Nielsen ME, Humaidan P, Dal Canto M, Fadini R, Schmidt KT, Ernst E, Yding Andersen C. LH-receptor gene expression in human granulosa and cumulus cells from antral and preovulatory follicles. J Clin Endocrinol Metab. 2012 Aug;97(8):E1524-31. doi: 10.1210/jc.2012-1427. Epub 2012 Jun 1. — View Citation
Lawrenz B, Beligotti F, Engelmann N, Gates D, Fatemi HM. Impact of gonadotropin type on progesterone elevation during ovarian stimulation in GnRH antagonist cycles. Hum Reprod. 2016 Nov;31(11):2554-2560. doi: 10.1093/humrep/dew213. Epub 2016 Sep 12. — View Citation
Lawrenz B, Fatemi HM. Effect of progesterone elevation in follicular phase of IVF-cycles on the endometrial receptivity. Reprod Biomed Online. 2017 Apr;34(4):422-428. doi: 10.1016/j.rbmo.2017.01.011. Epub 2017 Jan 24. — View Citation
Lawrenz B, Labarta E, Fatemi H, Bosch E. Premature progesterone elevation: targets and rescue strategies. Fertil Steril. 2018 Apr;109(4):577-582. doi: 10.1016/j.fertnstert.2018.02.128. — View Citation
Lawrenz B, Melado L, Fatemi H. Premature progesterone rise in ART-cycles. Reprod Biol. 2018 Mar;18(1):1-4. doi: 10.1016/j.repbio.2018.01.001. Epub 2018 Jan 6. — View Citation
Macklon NS, Stouffer RL, Giudice LC, Fauser BC. The science behind 25 years of ovarian stimulation for in vitro fertilization. Endocr Rev. 2006 Apr;27(2):170-207. doi: 10.1210/er.2005-0015. Epub 2006 Jan 24. — View Citation
Munch EM, Sparks AE, Zimmerman MB, Van Voorhis BJ, Duran EH. High FSH dosing is associated with reduced live birth rate in fresh but not subsequent frozen embryo transfers. Hum Reprod. 2017 Jul 1;32(7):1402-1409. doi: 10.1093/humrep/dex094. — View Citation
Oktem O, Akin N, Bildik G, Yakin K, Alper E, Balaban B, Urman B. FSH Stimulation promotes progesterone synthesis and output from human granulosa cells without luteinization. Hum Reprod. 2017 Mar 1;32(3):643-652. doi: 10.1093/humrep/dex010. — View Citation
Sunkara SK, Rittenberg V, Raine-Fenning N, Bhattacharya S, Zamora J, Coomarasamy A. Association between the number of eggs and live birth in IVF treatment: an analysis of 400 135 treatment cycles. Hum Reprod. 2011 Jul;26(7):1768-74. doi: 10.1093/humrep/der106. Epub 2011 May 10. — View Citation
Venetis CA, Kolibianakis EM, Bosdou JK, Tarlatzis BC. Progesterone elevation and probability of pregnancy after IVF: a systematic review and meta-analysis of over 60 000 cycles. Hum Reprod Update. 2013 Sep-Oct;19(5):433-57. doi: 10.1093/humupd/dmt014. Epub 2013 Jul 4. — View Citation
Wilcox AJ, Baird DD, Weinberg CR. Time of implantation of the conceptus and loss of pregnancy. N Engl J Med. 1999 Jun 10;340(23):1796-9. doi: 10.1056/NEJM199906103402304. — View Citation
* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of FSHR- and LHR of the GC, obtained from one follicle on the morning of day 5, before the administration of the first GnRH-antagonist, punctured during the ovarian stimulation cycle | 5 days | ||
Primary | Number of FSHR- and LHR of the GC, obtained from tone follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm, punctured during the ovarian stimulation cycle | 1 day | ||
Primary | Number of FSHR- and LHR of the GC, obtained from two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation, punctured during the ovarian stimulation cycle | 1 day | ||
Primary | Number of FSHR- and LHR of the GC, obtained from the follicular fluid of follicles aspirated during OPU | 1 day | ||
Secondary | Level of E2 hormone in the blood, the morning of day 5, before the administration of the first GnRH-antagonist | 5 days | ||
Secondary | Level of P4 hormone in the blood, the morning of day 5, before the administration of the first GnRH-antagonist | 5 days | ||
Secondary | Level of FSH hormone in the blood, the morning of day 5, before the administration of the first GnRH-antagonist | 5 days | ||
Secondary | Level of LH hormone in the blood, the morning of day 5, before the administration of the first GnRH-antagonist | 5 days | ||
Secondary | Level of E2 hormone in the blood, when there are at least 2 to 3 follicles with a size of 12 to 14 mm | 1 day | ||
Secondary | Level of P4 hormone in the blood, when there are at least 2 to 3 follicles with a size of 12 to 14 mm | 1 day | ||
Secondary | Level of FSH hormone in the blood, when there are at least 2 to 3 follicles with a size of 12 to 14 mm | 1 day | ||
Secondary | Level of LH hormone in the blood, when there are at least 2 to 3 follicles with a size of 12 to 14 mm | 1 day | ||
Secondary | Level of E2 hormone in the blood, on the morning of the day of final oocyte maturation | 1 day | ||
Secondary | Level of P4 hormone in the blood, on the morning of the day of final oocyte maturation | 1 day | ||
Secondary | Level of FSH hormone in the blood, on the morning of the day of final oocyte maturation | 1 day | ||
Secondary | Level of LH hormone in the blood, on the morning of the day of final oocyte maturation | 1 day | ||
Secondary | Level of E2 hormone in the blood, on the day of OPU | 1 day | ||
Secondary | Level of P4 hormone in the blood, on the day of OPU | 1 day | ||
Secondary | Level of FSH hormone in the blood, on the day of OPU | 1 day | ||
Secondary | Level of LH hormone in the blood, on the day of OPU | 1 day | ||
Secondary | Level of E2 hormone in the follicular fluid of one follicle on the morning of day 5, before the administration of the first GnRH-antagonist | 5 days | ||
Secondary | Level of P4 hormone in the follicular fluid of one follicle on the morning of day 5, before the administration of the first GnRH-antagonist | 5 days | ||
Secondary | Level of FSH hormone in the follicular fluid of one follicle on the morning of day 5, before the administration of the first GnRH-antagonist | 5 days | ||
Secondary | Level of LH hormone in the follicular fluid of one follicle on the morning of day 5, before the administration of the first GnRH-antagonist | 5 days | ||
Secondary | Level of E2 hormone in the follicular fluid of one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm | 1 day | ||
Secondary | Level of P4 hormone in the follicular fluid of one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm | 1 day | ||
Secondary | Level of FSH hormone in the follicular fluid of one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm | 1 day | ||
Secondary | Level of LH hormone in the follicular fluid of one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm | 1 day | ||
Secondary | Level of E2 hormone in the follicular fluid of two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation | 1 day | ||
Secondary | Level of P4 hormone in the follicular fluid of two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation | 1 day | ||
Secondary | Level of FSH hormone in the follicular fluid of two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation | 1 day | ||
Secondary | Level of LH hormone in the follicular fluid of two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation | 1 day | ||
Secondary | Level of E2 hormone in the follicular fluid of follicles aspirated during OPU | 1 day | ||
Secondary | Level of P4 hormone in the follicular fluid of follicles aspirated during OPU | 1 day | ||
Secondary | Level of FSH hormone in the follicular fluid of follicles aspirated during OPU | 1 day | ||
Secondary | Level of LH hormone in the follicular fluid of follicles aspirated during OPU | 1 day |
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