Progesterone Diurnal Rhythm During Ovarian Stimulation for IVF

Sponsor

ART Fertility Clinics LLC (Other)

Overall Status

Terminated

CT.gov ID

NCT02975713

Collaborator

(none)

Enrollment

Location

Actual Duration (Days)

28.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ovarian Hyperstimulation

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.

Study Design

Study Type:

Observational

Actual Enrollment :

12 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Progesterone Diurnal Rhythm During Ovarian Stimulation for IVF

Actual Study Start Date :

Nov 2, 2017

Actual Primary Completion Date :

Nov 14, 2017

Actual Study Completion Date :

Nov 15, 2017

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IVI Middle East Fertilty Clinic	Abu Dhabi		United Arab Emirates

Sponsors and Collaborators

ART Fertility Clinics LLC

Investigators

Principal Investigator: Human Mo Fatemi, Medical Director, IVI Middle East Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

Responsible Party:

Prof Dr. Human Fatemi, Medical Director, ART Fertility Clinics LLC

ClinicalTrials.gov Identifier:

NCT02975713

Other Study ID Numbers:

1609-ABU-070-HF

First Posted:

Nov 29, 2016

Last Update Posted:

Feb 28, 2018

Last Verified:

Feb 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Prof Dr. Human Fatemi, Medical Director, ART Fertility Clinics LLC

P4,ART,IVF,FSH,LH,AMH

Study Results

No Results Posted as of Feb 28, 2018