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

Acıbadem University Medical Faculty Atakent Hospital IVF Unit

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.

Study Overview

• Status: Unknown
• Conditions: HCG Day Follicle Diameter, Reproduction Results
• Intervention / Treatment: Other: descriptive

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34457
    • Active, not recruiting
    • Acibadem MAA University Atakent Hospital
  • Küçükçekmece
    • Istanbul, Küçükçekmece, Turkey, 34303
      • Recruiting
      • Acıbadem University Atakent Hospital
      • Contact: Turgut Aydın; Phone Number: 0905323722713; Email: drturgutaydin@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Live birth rate	live birth rate of participants	15 months
Clinical pregnancy rate	clinical pregnancy rate of participants	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oocyte maturation	Oocyte maturation rate of participants	6 months

Collaborators and Investigators

• Sponsor: Acibadem University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 20, 2020
• Primary Completion (ANTICIPATED): August 20, 2021
• Study Completion (ANTICIPATED): December 20, 2021

Study Registration Dates

• First Submitted: December 17, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (ACTUAL): December 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 6, 2021
• Last Update Submitted That Met QC Criteria: January 5, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: ATAKIVF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No