Progesterone Diurnal Rhythm During Ovarian Stimulation for IVF

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02975713

Enrollment

Registered

2016-11-29

Start date

2017-11-02

Completion date

2017-11-15

Last updated

2018-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Hyperstimulation

Keywords

P4,ART,IVF,FSH,LH,AMH

Brief 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.

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United Arab Emirates

Outcome results