Variation of Progesterone in IVF Cycles

NCT03519776 | Completed

• 1 other identifier: 1710-MUS-106-LB
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

to examine if a natural daytime variation in progesterone levels may explain parts of the inconsistent findings from studies reporting divergent results concerning this matter and will be carried out by several blood samples from the same patient during the day of ovulation triggering.

Conditions

Progesterone Resistance

Outcome Measures

Primary Outcomes (1)

• The variation of serum progesterone around the ovulation triggering in IVF-cycles

  the circadian secretion-pattern of progesterone during early follicular phase of normal cycling females

  6-8 months

Interventions

Progesterone variation DIAGNOSTIC_TEST

The potential gain for medical caretakers and patients would be a certainty if the progesterone level is affected by variations during daytime

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patient who will undergo IVF treatment

You may qualify if:

• patients 18-45 years
• BMI 18-35 kg/m2
• Menstrual cycle length 24-35 days
• Stimulation with rFSH or hMG

You may not qualify if:

• None

Sponsors & Collaborators

• ART Fertility Clinics LLC: lead

Study Sites (1)

IVI Middle East Fertilty Clinic

Abu Dhabi, United Arab Emirates

Location

Related Publications (10)

• Venetis CA, Kolibianakis EM, Bosdou JK, Lainas GT, Sfontouris IA, Tarlatzis BC, Lainas TG. Estimating the net effect of progesterone elevation on the day of hCG on live birth rates after IVF: a cohort analysis of 3296 IVF cycles. Hum Reprod. 2015 Mar;30(3):684-91. doi: 10.1093/humrep/deu362. Epub 2015 Jan 12.

  PMID: 25586787 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Requena A, Cruz M, Bosch E, Meseguer M, Garcia-Velasco JA. High progesterone levels in women with high ovarian response do not affect clinical outcomes: a retrospective cohort study. Reprod Biol Endocrinol. 2014 Jul 26;12:69. doi: 10.1186/1477-7827-12-69.

  PMID: 25064138 BACKGROUND

• 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 BACKGROUND

• Patton PE, Lim JY, Hickok LR, Kettel LM, Larson JM, Pau KY. Precision of progesterone measurements with the use of automated immunoassay analyzers and the impact on clinical decisions for in vitro fertilization. Fertil Steril. 2014 Jun;101(6):1629-36. doi: 10.1016/j.fertnstert.2014.02.037. Epub 2014 Mar 21.

  PMID: 24661729 BACKGROUND

• Bungum L, Jacobsson AK, Rosen F, Becker C, Yding Andersen C, Guner N, Giwercman A. Circadian variation in concentration of anti-Mullerian hormone in regularly menstruating females: relation to age, gonadotrophin and sex steroid levels. Hum Reprod. 2011 Mar;26(3):678-84. doi: 10.1093/humrep/deq380. Epub 2011 Jan 11.

  PMID: 21227943 BACKGROUND

• 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 BACKGROUND

• Thomsen LH, Kesmodel US, Andersen CY, Humaidan P. Daytime Variation in Serum Progesterone During the Mid-Luteal Phase in Women Undergoing In Vitro Fertilization Treatment. Front Endocrinol (Lausanne). 2018 Mar 19;9:92. doi: 10.3389/fendo.2018.00092. eCollection 2018.

  PMID: 29615975 BACKGROUND

• Shanker U, Lawrenz B, Bungum L, Depret Bixio L, Ruiz F, Coughlan C, Fatemi HM. Significant Serum Progesterone Variations on the Day of Final Oocyte Maturation in Stimulated IVF Cycles. Front Endocrinol (Lausanne). 2019 Nov 20;10:806. doi: 10.3389/fendo.2019.00806. eCollection 2019.

  PMID: 31824423 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be drawn. Each blood sample will consist of 10 cc of blood, to be centrifuged and the serum shared into 3 vials before freezing at minus 20 degrees.

MeSH Terms

Conditions

Progesterone Resistance

Study Officials

• Upma Shanker

  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: April 25, 2018
• First Posted: May 9, 2018
• Study Start: May 10, 2018
• Primary Completion: February 28, 2019
• Study Completion: March 31, 2019
• Last Updated: February 26, 2020

Record last verified: 2020-02

Locations

AE (1)