Variation of Progesterone in IVF Cycles

NCT ID: NCT03519776

Last Updated: 2020-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-10

Study Completion Date

2019-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Progesterone Resistance

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Progesterone variation

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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ART Fertility Clinics LLC

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Upma Shanker

Role: PRINCIPAL_INVESTIGATOR

ART Fertility Clinics LLC

Locations

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IVI Middle East Fertilty Clinic

Abu Dhabi, , United Arab Emirates

Site Status

Countries

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United Arab Emirates

References

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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.

Reference Type BACKGROUND
PMID: 25586787 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23827986 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24083873 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25064138 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21665546 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24661729 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21227943 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20539042 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29615975 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31824423 (View on PubMed)

Other Identifiers

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1710-MUS-106-LB

Identifier Type: -

Identifier Source: org_study_id

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