Progesterone Diurnal Rhythm During Ovarian Stimulation for IVF

Ovarian Hyperstimulation Clinical Trial

Official title:

Progesterone Diurnal Rhythm During Ovarian Stimulation for IVF

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02975713
• Other study ID #: 1609-ABU-070-HF
• Status: Terminated
• Phase: N/A
• First received: November 23, 2016
• Last updated: February 27, 2018
• Start date: November 2, 2017
• Est. completion date: November 15, 2017

Study information

• Verified date: February 2018
• Source: IVI Middle East Fertility Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To evaluate the influence of circadian rhythm on progesterone levels during follicular phase of natural cycle and during follicular phase of controlled ovarian stimulation during IVF.

Description:

The primary aim of this study is to determine the circadian rhythm of progesterone in a stimulated cycle. Sample size calculations show that the study needs to recruit 10 women to show any significant differences in progesterone secreted in the morning at 8 am compared to that secreted in the evening at 8 pm. We have increased the number of participants to 12 in order to compensate for any possible drop outs. The hormones FSH, LH, Progesterone and Estradiol will be measured at days 2/3, 8, 10 and 12 of a normal and stimulated cycle so that each patient serves as her own control.

This study will provide the basis to establish the optimal blood sampling time for progesterone measurement and to more accurately determine the cut-off level for progesterone for favourable pregnancy outcomes in ART.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: November 15, 2017
• Est. primary completion date: November 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Indication for IVF / ICSI - treatment

• Age = 18 years and = 35 years

• Ovarian reserve parameters in the adequate age - range, determined by Anti-Mullerian-Hormone (AMH) and Antral Follicle Count (AFC)(16)

• Able to understand the aim of the study and to provide consent

• Regular cycle (25-35 days)

Exclusion Criteria:

• Diagnosis of polycystic ovarian syndrome (PCOS) Rotterdam criteria

• Endometriosis stage 3 or 4 AFS

• Treatment with GnRH-analogues during the previous 6 months

• Intake of oral contraceptive pill (OCP) or any hormonal treatment during the last 3 months

Related Conditions & MeSH terms

• Ovarian Hyperstimulation
• Ovarian Hyperstimulation Syndrome

Locations

Country	Name	City	State
United Arab Emirates	IVI Middle East Fertilty Clinic	Abu Dhabi

Sponsors (1)

Lead Sponsor	Collaborator
IVI Middle East Fertility Clinic

Country where clinical trial is conducted

United Arab Emirates, 

References & Publications (14)

Bosch E, Labarta E, Crespo J, Simón C, Remohí 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( — View Citation

Bungum L, Franssohn F, Bungum M, Humaidan P, Giwercman A. The circadian variation in Anti-Müllerian hormone in patients with polycystic ovary syndrome differs significantly from normally ovulating women. PLoS One. 2013 Sep 4;8(9):e68223. doi: 10.1371/jour — View Citation

Bungum L, Jacobsson AK, Rosén F, Becker C, Yding Andersen C, Güner N, Giwercman A. Circadian variation in concentration of anti-Müllerian hormone in regularly menstruating females: relation to age, gonadotrophin and sex steroid levels. Hum Reprod. 2011 Ma — View Citation

Fatemi HM, Van Vaerenbergh I. Significance of premature progesterone rise in IVF. Curr Opin Obstet Gynecol. 2015 Jun;27(3):242-8. doi: 10.1097/GCO.0000000000000172. Review. — View Citation

Huang R, Fang C, Xu S, Yi Y, Liang X. Premature progesterone rise negatively correlated with live birth rate in IVF cycles with GnRH agonist: an analysis of 2,566 cycles. Fertil Steril. 2012 Sep;98(3):664-670.e2. doi: 10.1016/j.fertnstert.2012.05.024. Epu — View Citation

Kyrou D, Popovic-Todorovic B, Fatemi HM, Bourgain C, Haentjens P, Van Landuyt L, Devroey P. Does the estradiol level on the day of human chorionic gonadotrophin administration have an impact on pregnancy rates in patients treated with rec-FSH/GnRH antagon — View Citation

Labarta E, Martínez-Conejero JA, Alamá P, Horcajadas JA, Pellicer A, Simón C, Bosch E. Endometrial receptivity is affected in women with high circulating progesterone levels at the end of the follicular phase: a functional genomics analysis. Hum Reprod. 2 — View Citation

Ochsenkühn R, Arzberger A, von Schönfeldt V, Gallwas J, Rogenhofer N, Crispin A, Thaler CJ, Noss U. Subtle progesterone rise on the day of human chorionic gonadotropin administration is associated with lower live birth rates in women undergoing assisted r — View Citation

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. — View Citation

Seifer DB, Baker VL, Leader B. Age-specific serum anti-Müllerian hormone values for 17,120 women presenting to fertility centers within the United States. Fertil Steril. 2011 Feb;95(2):747-50. doi: 10.1016/j.fertnstert.2010.10.011. Epub 2010 Nov 13. — View Citation

Strott CA, Yoshimi T, Lipsett MB. Plasma progesterone and 17-hydroxyprogesterone in normal men and children with congenital adrenal hyperplasia. J Clin Invest. 1969 May;48(5):930-9. — View Citation

Van Vaerenbergh I, Fatemi HM, Blockeel C, Van Lommel L, In't Veld P, Schuit F, Kolibianakis EM, Devroey P, Bourgain C. Progesterone rise on HCG day in GnRH antagonist/rFSH stimulated cycles affects endometrial gene expression. Reprod Biomed Online. 2011 M — 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. Epu — View Citation

Xu B, Li Z, Zhang H, Jin L, Li Y, Ai J, Zhu G. Serum progesterone level effects on the outcome of in vitro fertilization in patients with different ovarian response: an analysis of more than 10,000 cycles. Fertil Steril. 2012 Jun;97(6):1321-7.e1-4. doi: 1 — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progesterone levels during follicular phase	The primary aim of this study is to determine the circadian rhythm of progesterone in a stimulated cycle.	2-4 months

External Links

•   Changes in Plasma Progesterone Concentrations around the Time of the Luteinizing Hormone Surge in Women Superovulated for in Vitro Fertilization
•   Progesterone rise on the day of human chorionic gonadotropin administration impairs pregnancy outcome in day 3 single-embryo transfer, while has no effect on day 5 single blastocyst transfer