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Comparison of Follicle Diameter on hCG Day and Follicle Diameters on OPU (Oocyte Pick up) Day and the Effect of Follicle Diameters on Embryo Development and Pregnancy Outcomes

Sponsor
Acibadem University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04679688
Collaborator
(none)
100
Enrollment
2
Locations
12
Anticipated Duration (Months)
50
Patients Per Site
4.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: descriptive
 N/A

Detailed Description

In our study, patients with 5 and 10 follicles exceeding 11 mm will be included in order to define the follicles whose hCG day is measured more clearly on the day of OPU in patients with whom we performed controlled ovarian hyperstimulation for in vitro fertilisation(IVF). The localizations and diameters of these follicles in both ovaries will be drawn and the hCG day will be numbered and their measurements will be indicated. On the day of opu, the marked and numbered follicles will be measured, noted and aspirated one by one, the collected eggs will be followed in individually numbered culture dish and it will be evaluated whether they are mature or not prepared for microinjection. And mature oocytes will be followed in numbered culture dishes after microinjection. The relationship between hCG and OPU day follicle diameter will be evaluated by following the follicle diameter and follicle diameters on the day of egg collection, the relationship between the mature egg, the rate of reaching the blastocyst stage, the clinical pregnancy and live birth rates

Especially the relationship between mature egg and follicle diameter and the resulting clinical results may guide clinicians in practice.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
Single (Participant)
Primary Purpose:
Diagnostic
Official Title:
Acıbadem University Medical Faculty Atakent Hospital IVF Unit
Actual Study Start Date :
Dec 20, 2020
Anticipated Primary Completion Date :
Aug 20, 2021
Anticipated Study Completion Date :
Dec 20, 2021

Outcome Measures

Primary Outcome Measures

  1. Live birth rate [15 months]

    live birth rate of participants

  2. Clinical pregnancy rate [6 months]

    clinical pregnancy rate of participants

Secondary Outcome Measures

  1. Oocyte maturation [6 months]

    Oocyte maturation rate of participants

Eligibility Criteria

Criteria

Ages Eligible for Study:
23 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

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

  2. Patient group with BMI below 30.

Exclusion Criteria:

  1. PCO patient group,

  2. Male factor group with severe OAT,

  3. Patient group with endometriosis,

  4. Patient group with PGD indication,

  5. The group under the age of 40 and legally deserving of double embryo transfer

Contacts and Locations

Locations

Site City State Country Postal Code
1 Acıbadem University Atakent Hospital Istanbul Küçükçekmece Turkey 34303
2 Acibadem MAA University Atakent Hospital Istanbul Turkey 34457

Sponsors and Collaborators

  • Acibadem University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Acibadem University
ClinicalTrials.gov Identifier:
NCT04679688
Other Study ID Numbers:
  • ATAKIVF
First Posted:
Dec 22, 2020
Last Update Posted:
Jan 6, 2021
Last Verified:
Dec 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 6, 2021