AzTrials
AzTrials

Ovarian HyperstimulationNCT02975713

Progesterone Diurnal Rhythm During Ovarian Stimulation for IVF

An observational study of Ovarian Hyperstimulation, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Ovarian Hyperstimulation
How many people
12 participants
Where
1 siteUnited Arab Emirates
Study dates
2 Nov 2017to 15 Nov 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Study population: Patients who have to undergo IVF due to primary or secondary infertility.

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United Arab Emirates1 site

  • IVI Middle East Fertilty Clinic

    Abu Dhabi

Other trials in United Arab Emirates

About this study

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.

Read the detailed 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.

Keywords
P4,ART,IVF,FSH,LH,AMH

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progesterone levels during follicular phase

    The primary aim of this study is to determine the circadian rhythm of progesterone in a stimulated cycle.

    Measured: 2-4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2016 (estimated)
  2. Study start2 Nov 2017
  3. Primary completion14 Nov 2017
  4. Study completion15 Nov 2017

Why it stopped: no participants were recruited,study stopped

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02975713
Sponsor's protocol ID
1609-ABU-070-HF
Status last verified
Feb 2018
First submitted
23 Nov 2016
Last updated
28 Feb 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25811257

  • 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.

    PubMed 24661729

  • 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.

    PubMed 23827986

  • 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. Epub 2012 Jun 15.

    PubMed 22704632

  • Ochsenkuhn R, Arzberger A, von Schonfeldt 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 reproductive technology: a retrospective study with 2,555 fresh embryo transfers. Fertil Steril. 2012 Aug;98(2):347-54. doi: 10.1016/j.fertnstert.2012.04.041. Epub 2012 May 24.

    PubMed 22633265

  • 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: 10.1016/j.fertnstert.2012.03.014. Epub 2012 Apr 10.

    PubMed 22494924

  • Labarta E, Martinez-Conejero JA, Alama P, Horcajadas JA, Pellicer A, Simon 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. 2011 Jul;26(7):1813-25. doi: 10.1093/humrep/der126. Epub 2011 May 2.

    PubMed 21540246

  • 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 Mar;22(3):263-71. doi: 10.1016/j.rbmo.2010.11.002. Epub 2010 Nov 13.

    PubMed 21273126

  • 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.

    PubMed 20539042

  • 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 antagonist? Hum Reprod. 2009 Nov;24(11):2902-9. doi: 10.1093/humrep/dep290. Epub 2009 Aug 11.

    PubMed 19671625

  • 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. doi: 10.1172/JCI106052.

    PubMed 4305376

  • 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.

    PubMed 21227943

  • Bungum L, Franssohn F, Bungum M, Humaidan P, Giwercman A. The circadian variation in Anti-Mullerian hormone in patients with polycystic ovary syndrome differs significantly from normally ovulating women. PLoS One. 2013 Sep 4;8(9):e68223. doi: 10.1371/journal.pone.0068223. eCollection 2013.

    PubMed 24023708

  • Seifer DB, Baker VL, Leader B. Age-specific serum anti-Mullerian 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.

    PubMed 21074758

Questions about this trial

What is this clinical trial studying?

An observational study of Ovarian Hyperstimulation, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: no participants were recruited,study stopped). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progesterone levels during follicular phase (time frame: 2-4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02975713, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2018.

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