Variation of Progesterone in IVF Cycles

Progesterone Resistance Clinical Trial

Official title:

Variation of Progesterone in IVF Cycles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03519776
• Other study ID #: 1710-MUS-106-LB
• Status: Completed
• Start date: May 10, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: February 2020
• Source: IVI Middle East Fertility Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The impact of the progesterone level at the end of the follicular phase in stimulated IVF/ICSI cycles and its effect on the pregnancy rate and oocyte quality is controversial, which arises from conflicting results in retrospective studies and meta-analyses. This study is assumed 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. If variation is present, the impact of variation on the developing oocyte and embryo quality will be estimated by embryo quality indicators.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 31, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• patients 18-45 years

• BMI 18-35 kg/m2

• Menstrual cycle length 24-35 days

• Stimulation with rFSH or hMG

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Progesterone Resistance

Intervention

Diagnostic Test:
• Progesterone variation
The potential gain for medical caretakers and patients would be a certainty if the progesterone level is affected by variations during daytime

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 (9)

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(8):2092-100. doi: 10.1093/humrep/deq125. Epub 2010 Jun 10. — 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 Mar;26(3):678-84. doi: 10.1093/humrep/deq380. Epub 2011 Jan 11. — View Citation

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. — 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

Requena A, Cruz M, Bosch E, Meseguer M, García-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. — View Citation

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. — View Citation

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. — 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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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