Variation of Progesterone in IVF Cycles

Sponsor
ART Fertility Clinics LLC (Other)
Overall Status
Completed
CT.gov ID
NCT03519776
Collaborator
(none)
30
1
10.7
2.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Progesterone variation

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
30 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Variation of Progesterone in IVF Cycles
Actual Study Start Date :
May 10, 2018
Actual Primary Completion Date :
Feb 28, 2019
Actual Study Completion Date :
Mar 31, 2019

Outcome Measures

Primary Outcome Measures

  1. The variation of serum progesterone around the ovulation triggering in IVF-cycles [6-8 months]

    the circadian secretion-pattern of progesterone during early follicular phase of normal cycling females

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

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: Upma Shanker, ART Fertility Clinics LLC

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
ART Fertility Clinics LLC
ClinicalTrials.gov Identifier:
NCT03519776
Other Study ID Numbers:
  • 1710-MUS-106-LB
First Posted:
May 9, 2018
Last Update Posted:
Feb 26, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 26, 2020