Clinical trial NCT04679688: 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
Official title: Acıbadem University Medical Faculty Atakent Hospital IVF Unit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HCG Day Follicle Diameter, Reproduction Results
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 100
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Live birth rate
timeFrame: 15 months
measure: Clinical pregnancy rate
timeFrame: 6 months
Secondary outcomes:
measure: Oocyte maturation
timeFrame: 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acıbadem University Atakent Hospital
state: Küçükçekmece
city: Istanbul
country: Turkey
facility: Acibadem MAA University Atakent Hospital
Study officials:
References: