A Proof of Concept Study of Serum Progesterone Levels for IVF/ICSI Following HCG Trigger for Oocyte Maturation

NCT04417569 | Completed DMC

• 1 other identifier: 2002-ABU-001-CC
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine the rise of progesterone levels after human chorionic gonadotrophin (hCG) trigger in stimulated cycles IVF/ICSI

Conditions

Infertility; Infertility, Female; IVF; hCG

Outcome Measures

Primary Outcomes (1)

• Level of progesterone day of trigger

  day of the hCG trigger between 1000h - 1200h, before trigger, 1 hour after trigger, 2 hrs after trigger

  1 day

Secondary Outcomes (1)

• Level of progesterone day of egg retrieval

  1 day

Study Arms (1)

stimulated cycles

Patients will have blood drawn on five separate occasions: before and following hCG trigger on the day of final oocyte maturation and day of egg collection

Drug: hCG; Diagnostic Test: Ultrasound; Other: Blood test

Interventions

hCG DRUG

human chorionic gonadotropin

Also known as: human chorionic gonadotropin

stimulated cycles

Ultrasound DIAGNOSTIC_TEST

Endometrial thickness monitoring

Also known as: transvaginal scan

stimulated cycles

Blood test OTHER

Progesterone, Luteinizing Hormone, Estradiol

Also known as: Progesterone, Luteinizing Hormone, Estradiol

stimulated cycles

Eligibility Criteria

• Age: 18 Years - 42 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Female patients who are planned to commence ovarian stimulation for IVF/ICSI with hCG trigger for oocyte maturation and plan to avail of pre-implantation genetic screening with embryo vitrification of their biopsied embryos at blastocyst stage

You may qualify if:

• Females aged 18 to 42 years with regular menstrual cycles of 26-34 days
• Undergoing ovarian stimulation for IVF/ICSI \& PGS.
• Receiving recombinant FSH for stimulation
• hCG 5000iu IM as trigger injection for oocyte maturation.
• Ovarian stimulation in GnRH-antagonist protocols
• BMI 18- 35 kg/m2
• Having 1 or 2 euploid embryos for transfer in spontaneous natural cycles.

You may not qualify if:

• Poor ovarian reserve as defined by Bologna criteria
• PCOS in accordance with Rotterdam criteria

Sponsors & Collaborators

• ART Fertility Clinics LLC: lead

Study Sites (1)

ART Fertility Clinics LLC

Abu Dhabi, 60202, United Arab Emirates

Location

Related Publications (21)

• Bourgain C, Devroey P. The endometrium in stimulated cycles for IVF. Hum Reprod Update. 2003 Nov-Dec;9(6):515-22. doi: 10.1093/humupd/dmg045.

  PMID: 14714588 RESULT

• Devroey P, Bourgain C, Macklon NS, Fauser BC. Reproductive biology and IVF: ovarian stimulation and endometrial receptivity. Trends Endocrinol Metab. 2004 Mar;15(2):84-90. doi: 10.1016/j.tem.2004.01.009.

  PMID: 15036255 RESULT

• Kolibianakis E, Bourgain C, Albano C, Osmanagaoglu K, Smitz J, Van Steirteghem A, Devroey P. Effect of ovarian stimulation with recombinant follicle-stimulating hormone, gonadotropin releasing hormone antagonists, and human chorionic gonadotropin on endometrial maturation on the day of oocyte pick-up. Fertil Steril. 2002 Nov;78(5):1025-9. doi: 10.1016/s0015-0282(02)03323-x.

  PMID: 12413988 RESULT

• Nikas G, Develioglu OH, Toner JP, Jones HW Jr. Endometrial pinopodes indicate a shift in the window of receptivity in IVF cycles. Hum Reprod. 1999 Mar;14(3):787-92. doi: 10.1093/humrep/14.3.787.

  PMID: 10221715 RESULT

• Simon C, Garcia Velasco JJ, Valbuena D, Peinado JA, Moreno C, Remohi J, Pellicer A. Increasing uterine receptivity by decreasing estradiol levels during the preimplantation period in high responders with the use of a follicle-stimulating hormone step-down regimen. Fertil Steril. 1998 Aug;70(2):234-9. doi: 10.1016/s0015-0282(98)00140-x.

  PMID: 9696213 RESULT

• Weinerman R, Mainigi M. Why we should transfer frozen instead of fresh embryos: the translational rationale. Fertil Steril. 2014 Jul;102(1):10-8. doi: 10.1016/j.fertnstert.2014.05.019. Epub 2014 Jun 2.

  PMID: 24890274 RESULT

• Liu Y, Lee KF, Ng EH, Yeung WS, Ho PC. Gene expression profiling of human peri-implantation endometria between natural and stimulated cycles. Fertil Steril. 2008 Dec;90(6):2152-64. doi: 10.1016/j.fertnstert.2007.10.020. Epub 2008 Jan 14.

  PMID: 18191855 RESULT

• Haouzi D, Assou S, Mahmoud K, Tondeur S, Reme T, Hedon B, De Vos J, Hamamah S. Gene expression profile of human endometrial receptivity: comparison between natural and stimulated cycles for the same patients. Hum Reprod. 2009 Jun;24(6):1436-45. doi: 10.1093/humrep/dep039. Epub 2009 Feb 26.

  PMID: 19246470 RESULT

• Roque M, Lattes K, Serra S, Sola I, Geber S, Carreras R, Checa MA. Fresh embryo transfer versus frozen embryo transfer in in vitro fertilization cycles: a systematic review and meta-analysis. Fertil Steril. 2013 Jan;99(1):156-162. doi: 10.1016/j.fertnstert.2012.09.003. Epub 2012 Oct 3.

  PMID: 23040524 RESULT

• Roque M, Valle M, Guimaraes F, Sampaio M, Geber S. Freeze-all policy: fresh vs. frozen-thawed embryo transfer. Fertil Steril. 2015 May;103(5):1190-3. doi: 10.1016/j.fertnstert.2015.01.045. Epub 2015 Mar 4.

  PMID: 25747130 RESULT

• Haas J, Smith R, Zilberberg E, Nayot D, Meriano J, Barzilay E, Casper RF. Endometrial compaction (decreased thickness) in response to progesterone results in optimal pregnancy outcome in frozen-thawed embryo transfers. Fertil Steril. 2019 Sep;112(3):503-509.e1. doi: 10.1016/j.fertnstert.2019.05.001. Epub 2019 Jun 24.

  PMID: 31248618 RESULT

• Testart J, Frydman R, Feinstein MC, Thebault A, Roger M, Scholler R. Interpretation of plasma luteinizing hormone assay for the collection of mature oocytes from women: definition of a luteinizing hormone surge-initiating rise. Fertil Steril. 1981 Jul;36(1):50-4. doi: 10.1016/s0015-0282(16)45617-7.

  PMID: 7250407 RESULT

• Irani M, Robles A, Gunnala V, Reichman D, Rosenwaks Z. Optimal parameters for determining the LH surge in natural cycle frozen-thawed embryo transfers. J Ovarian Res. 2017 Oct 16;10(1):70. doi: 10.1186/s13048-017-0367-7.

  PMID: 29037231 RESULT

• Groenewoud ER, Macklon NS, Cohlen BJ; ANTARCTICA Study Group. The effect of elevated progesterone levels before HCG triggering in modified natural cycle frozen-thawed embryo transfer cycles. Reprod Biomed Online. 2017 May;34(5):546-554. doi: 10.1016/j.rbmo.2017.02.008. Epub 2017 Feb 28.

  PMID: 28319018 RESULT

• Fatemi HM, Kyrou D, Bourgain C, Van den Abbeel E, Griesinger G, Devroey P. Cryopreserved-thawed human embryo transfer: spontaneous natural cycle is superior to human chorionic gonadotropin-induced natural cycle. Fertil Steril. 2010 Nov;94(6):2054-8. doi: 10.1016/j.fertnstert.2009.11.036. Epub 2010 Jan 25.

  PMID: 20097333 RESULT

• Bosch E, Labarta E, Crespo J, Simon C, Remohi J, Jenkins J, Pellicer A. Circulating progesterone levels and ongoing pregnancy rates in controlled ovarian stimulation cycles for in vitro fertilization: analysis of over 4000 cycles. Hum Reprod. 2010 Aug;25(8):2092-100. doi: 10.1093/humrep/deq125. Epub 2010 Jun 10.

  PMID: 20539042 RESULT

• Griesinger G, Mannaerts B, Andersen CY, Witjes H, Kolibianakis EM, Gordon K. Progesterone elevation does not compromise pregnancy rates in high responders: a pooled analysis of in vitro fertilization patients treated with recombinant follicle-stimulating hormone/gonadotropin-releasing hormone antagonist in six trials. Fertil Steril. 2013 Dec;100(6):1622-8.e1-3. doi: 10.1016/j.fertnstert.2013.08.045. Epub 2013 Sep 29.

  PMID: 24083873 RESULT

• 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.

  PMID: 23827986 RESULT

• Yding Andersen C, Bungum L, Nyboe Andersen A, Humaidan P. Preovulatory progesterone concentration associates significantly to follicle number and LH concentration but not to pregnancy rate. Reprod Biomed Online. 2011 Aug;23(2):187-95. doi: 10.1016/j.rbmo.2011.04.003. Epub 2011 Apr 28.

  PMID: 21665546 RESULT

• Friis Wang N, Skouby SO, Humaidan P, Andersen CY. Response to ovulation trigger is correlated to late follicular phase progesterone levels: A hypothesis explaining reduced reproductive outcomes caused by increased late follicular progesterone rise. Hum Reprod. 2019 May 1;34(5):942-948. doi: 10.1093/humrep/dez023.

  PMID: 30927415 RESULT

• Coughlan C, Vitorino R, Melado L, Digma S, Sibal J, Patel R, Lawrenz B, Fatemi H. Evolution of serum progesterone levels in the very early luteal phase of stimulated IVF/ICSI cycles post hCG trigger: a proof of concept study. J Assist Reprod Genet. 2022 May;39(5):1095-1104. doi: 10.1007/s10815-022-02474-4. Epub 2022 Apr 7.

  PMID: 35391631 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Infertility; Infertility, Female

Interventions

Chorionic Gonadotropin; Ultrasonography; Hematologic Tests; Progesterone; Luteinizing Hormone; Estradiol

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Placental Hormones; Peptides; Amino Acids, Peptides, and Proteins; Pregnancy Proteins; Proteins; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Clinical Laboratory Techniques; Investigative Techniques; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Progesterone Congeners; Gonadal Steroid Hormones; Gonadotropins, Pituitary; Pituitary Hormones, Anterior; Pituitary Hormones; Estrenes; Estranes; Estradiol Congeners

Study Officials

• Raquel Loja Vitorino, Specialist

  ART Fertility Clinics LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: June 4, 2020
• Study Start: February 4, 2021
• Primary Completion: May 26, 2021
• Study Completion: June 30, 2021
• Last Updated: February 18, 2022

Record last verified: 2022-02

Locations

AE (1)