NCT04679688

Brief Summary

Evaluation of follicle diameters on human chorionic gonadotrophin(hCG) day and oocyte pick up (OPU) day of follicles developing after gonadotropin treatment, the relationship between follicle diameter and maturation in oocytes obtained after OPU and its effect on pregnancy outcomes will be investigated. In order to make it easier to measure and enumerate the follicle diameters with the help of vaginal ultrasound, patients under 35 years of age with at most five follicles in any ovary and at least four follicles in both ovaries will be included in the study.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

December 20, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

January 6, 2021

Status Verified

December 1, 2020

Enrollment Period

8 months

First QC Date

December 17, 2020

Last Update Submit

January 5, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • Live birth rate

    live birth rate of participants

    15 months

  • Clinical pregnancy rate

    clinical pregnancy rate of participants

    6 months

Secondary Outcomes (1)

  • Oocyte maturation

    6 months

Interventions

Those who apply for IVF treatment and have an antral follicle number of 4-10 will be included in the treatment. The reason for including patients with this number of antral follicles in the study is to determine the follicle locations and to determine each growing follicle separately on the day of hCG and egg collection.

Also known as: The effect of follicle diameters on embryo development and pregnancy outcomes.

Eligibility Criteria

Age23 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patient group with at least 5 and at most 10 follicles in each ovary whose hCG day exceeds 11 mm,
  • Patient group with BMI below 30.

You may not qualify if:

  • PCO patient group,
  • Male factor group with severe OAT,
  • Patient group with endometriosis,
  • Patient group with PGD indication,
  • The group under the age of 40 and legally deserving of double embryo transfer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Acıbadem University Atakent Hospital

Istanbul, Küçükçekmece, 34303, Turkey (Türkiye)

RECRUITING

Acibadem MAA University Atakent Hospital

Istanbul, 34457, Turkey (Türkiye)

ACTIVE NOT RECRUITING

MeSH Terms

Interventions

Pregnancy Outcome

Intervention Hierarchy (Ancestors)

PrognosisDiagnosisPregnancyReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2020

First Posted

December 22, 2020

Study Start

December 20, 2020

Primary Completion

August 20, 2021

Study Completion

December 20, 2021

Last Updated

January 6, 2021

Record last verified: 2020-12

Locations